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<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:36.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:712.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:723.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:733.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:744.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:157.50pt;top:50.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">ATDEPARTMENT OF HEALTH AND HUMAN SERVICES</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:240.75pt;top:77.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">FOOD AND DRUG ADMINISTRATION</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:215.25pt;top:266.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">APPLICATION OF NUCLEIC ACID TESTING</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:161.25pt;top:293.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">TO BLOOD BORNE PATHOGENS AND EMERGING TECHNOLOGIES</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:262.50pt;top:321.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">OBRR/CBER/FDA WORKSHOP</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.25pt;top:512.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Tuesday, December 4, 2001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:309.00pt;top:539.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">8:30 a.m.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:262.50pt;top:675.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Lister Hill Auditorium</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:237.00pt;top:689.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">National Institutes of Health</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:792.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:828.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:1504.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:1515.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:1525.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:1536.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:273.00pt;top:842.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">8600 Rockville Pike</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:276.75pt;top:855.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Bethesda, Maryland</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:1584.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:1620.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:2296.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:2307.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:2317.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:2328.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:287.25pt;top:1647.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">C O N T E N T S</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:528.75pt;top:1675.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">PAGE</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:1702.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Opening Remarks: J. Epstein</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:1702.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:1729.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Overview of NAT and Reduction of Residual Risk</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:1742.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in Infectious Disease Transmission: M. Busch</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:550.50pt;top:1742.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:1769.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">New "Hepatitis" Viruses: Do they Make Sense?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:1784.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">H. Alter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:1784.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">38</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:208.50pt;top:1810.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I. Regulatory Issues and Perspectives</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:291.00pt;top:1823.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">(Mied/Hewlett)</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:1851.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">US FDA: Implementation of NAT for HCV and HIV:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:1865.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">P. Mied</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:1865.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">56</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:1878.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">PEI: M. Nubling</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:1878.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">72</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:165.00pt;top:1905.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">II. Standardization/Quality Assurance (Yu/Biswas)</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:1933.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NIBSC/WHO Program: J. Saldanha</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:543.00pt;top:1933.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">94</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:1946.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Europe: M Nubling</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:1946.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">110</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:1960.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">CBER/FDA: M.W. Yu</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:1960.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">123</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:204.75pt;top:1986.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">III.  Experience with Minipool NAT for</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:287.25pt;top:2000.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Donor Screening</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:294.75pt;top:2014.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">(HIV/HBV/HCV)</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.75pt;top:2027.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Industry Presentations (Yuwen/Li)</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2055.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Plasma for Further Manufacturing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:2082.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NGI: A. Conrad</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:2082.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">135</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:2096.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Alpha: L. Peddada</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:2096.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">143</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:2110.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Baxter: D. Baker</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:2110.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">149</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:2123.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">BaxterHylandImmuno: G. Zerlauth</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:535.50pt;top:2123.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">153</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:2137.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Bayer: B. Masecar</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:2137.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">157</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:2150.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Aventis: C. Watson</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:2150.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">167</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2177.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Blood Bank Experience</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:2204.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Gen-Probe: L. Mimms 170</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:2219.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Roche: J. Gallarda</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:2219.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">178</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:2232.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">ARC: S. Stramer</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:2232.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">186</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:2246.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">ABC: C. Bianco</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:2246.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">196</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:2259.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">AIBC: R. Gammon</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:2259.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">202</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:2376.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:2412.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:3088.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:3099.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:3109.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:3120.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:201.00pt;top:2425.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">IV. Progress Towards Single Unit NAT (Yuwen/Li)</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2453.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Duplex(HIV/HCV) TMA, Gen-Probe: S. McDonough</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:535.50pt;top:2453.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">211</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2467.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Triplex (HIV/HCV/HBV) TMA, Gen-Probe: C. Giachetti</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:535.50pt;top:2467.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">220</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2480.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Plans to Transition from Minipool Testing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2494.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to Single-Unit NAT Testing, Roche, J. Gallarda</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:535.50pt;top:2494.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">236</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2507.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Japanese Experience with Single Unit NAT:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:2521.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Y. Yoshikawa</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:2521.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">244</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:3168.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:3204.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:3880.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:3891.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:3901.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:3912.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:244.50pt;top:3245.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 12.00pt">C O N T E N T S </FONT></u><FONT STYLE="font-size: 12.00pt">(Continued)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:528.75pt;top:3272.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">PAGE</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:193.50pt;top:3299.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">V. Experience with Minipool NAT Screening</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:262.50pt;top:3312.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for HAV/Parvovirus B19</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:219.00pt;top:3326.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Industry Presentations (Yu/Kaplan)</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:3353.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Plans for Further Manufacturing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:3381.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Aventis: C. Watson</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:3381.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">249</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:3395.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NGI: R. Smith</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:3395.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">259</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:3408.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Alpha: L. Peddada</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:3408.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">270</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:3422.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Baxter: D. Baker</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:3422.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">276</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:3435.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">BaxterHylandImmuno, G. Zerlauth</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:535.50pt;top:3435.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">279</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:3449.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Bayer: T. Gierman</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:3449.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">285</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:3476.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Blood Bank Experience</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:3503.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Gen-Probe: L. Stringfellow</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:535.50pt;top:3503.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">294</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:3517.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Roche: C. Majewski</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:3517.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">298</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:3530.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">ARC: S. Stramer</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:3530.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">308</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:3960.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:3996.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:4672.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:4683.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:4693.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:4704.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:265.50pt;top:4022.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">P R O C E E D I N G S</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:287.25pt;top:4048.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Opening Remarks</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:4076.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. EPSTEIN:  Good morning.  Welcome to our two-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4102.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">day workshop on the application of a nucleic acid-based</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4128.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">test for the blood supply.  I am especially pleased to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4154.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">welcome here the participation of investigators from other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4181.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">countries who have been in the vanguard of research to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4208.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">evaluate the use of nucleic acid tests to screen blood and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4234.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">plasma for relevant viral agents.  In particular, we are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4261.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">pleased to have several representatives from Europe and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4287.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Japan at the workshop and we are looking forward to hearing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4313.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">about their extensive experience with NAT.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:4340.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">CBER began meeting with industry representatives</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4367.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in 1998 in order to guide the development of nucleic acid</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4393.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">testing.  At this time, nearly all the blood and plasma</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4419.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">collected in the United States is being screened by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4445.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">minipool methods using NAT for hepatitis C and HIV.  Some</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4472.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">plasma is also being screened for hepatitis B by minipool</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4499.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NAT.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:4525.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">It is also, I think, a landmark that on September</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4551.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">18th FDA approved two NAT procedures for screening source</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4578.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">plasma by minipool testing, those being the tests of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4604.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">National Genetics Institute, the so-called UltraQual HIV-1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4631.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and HCV reverse transcription polymerase chain reaction</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4658.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">assays, and one company, Alpha Therapeutic Corporation, is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:4752.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:4788.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:5464.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:5475.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:5485.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:5496.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4814.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">licensed for use of these procedures in screening of source</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4841.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">plasma.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:4868.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">FDA is developing a draft guidance on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4894.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">implementation of licensed NAT for screening minipools of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4920.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">source plasma, which is in the final stages of preparation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4946.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and the concepts will be discussed later in the workshop by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:4973.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Dr. Mied.  The processing of blood and plasma collected in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5000.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the United States includes screening by highly sensitive,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5026.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">so-called conventional immunoassays which are able to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5053.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">eliminate units harboring infection for hepatitis C, HIV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5079.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and hepatitis B.  It needs to be recognized that the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5105.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">technology to detect these viruses already permits a very</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5132.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">high degree of safety.  Nevertheless, we know that some</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5159.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">infectious units do escape detection by immunoassays.  The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5185.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">nucleic acid methods permit us to eliminate many of these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5211.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">remaining infectious units due to their remarkable</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5237.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sensitivity.  Indeed, it is now possible to detect, at 95</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5264.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">percent confidence, as few as 10 copies per milliliter of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5291.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">these agents using nucleic acid test methods.  Indeed, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5317.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sensitivity is now limited mainly by dilutional factors</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5343.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">such as used in the minipool format.  So, we expect that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5370.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the progression from the minipool to the single unit NAT,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5396.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">when technologically and practically feasible, will make it</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5423.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">possible to eliminate virtually all window period</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5450.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donations.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:5544.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:5580.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:6256.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:6267.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:6277.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:6288.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:5606.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We all know that plasma derivatives are subjected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5633.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to procedures that would remove or inactivate all hepatitis</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5660.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">C, HIV and hepatitis B when performed appropriately.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5686.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">However, FDA does see the highly sensitive screening as a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5712.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">necessary additional safeguard which serves to limit the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5738.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">viral burden in any fractionation pool, thereby helping to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5765.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">assure the sufficiency of inactivation procedures.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:5792.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, today's and tomorrow's agendas have been well</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5818.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">crafted to address a spectrum of issues.  I am just going</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5845.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to note what they are.  We will review the experience to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5871.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">date with the implementation of NAT for hepatitis C, HIV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5897.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and hepatitis B; the status of standardization of NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5924.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">testing which, you know, has been a major international</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5951.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">cooperative effort; progress toward the development of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:5977.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">single-unit NAT; the salient differences for NAT directed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6003.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to hepatitis A and parvovirus B19 as they night be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6029.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">implemented in the donor and manufacturing setting; the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6056.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">potential for NAT to replace certain existing tests, such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6083.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">as the HIV-1 p24 antigen test; additional infectious agents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6109.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for which NAT screening may be possible, including emerging</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6135.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">pathogens; and the use of new technologies to make high</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6162.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">throughput NAT even more cost effective.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:6188.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Personally, I am looking forward to a highly</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6215.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">productive exchange of information at this workshop, and I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6242.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">hope that this meeting will again enable FDA and the blood</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:6336.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:6372.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:7048.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:7059.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:7069.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:7080.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6398.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">industry to move quickly and effectively toward full</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6425.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">implementation of NAT in a way that best serve the public</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6452.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">health.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:6478.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, again, my warmest welcome and I will call on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6504.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Dr. Michael Busch, from Blood Centers of the Pacific, who</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6530.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">will speak to us on an overview of NAT and reduction of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6557.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">residual risk in infectious disease transmission.  Mike?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:175.50pt;top:6583.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Overview of NAT and Reduction of Residual Risk</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:219.00pt;top:6609.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in Infectious Disease Transmission</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:6637.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. BUSCH:  Thank you, Jay.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:6663.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:6689.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">It is my privilege to be able to briefly review</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6716.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the history of screening, the great success story that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6743.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">blood screening has achieved, and talk particularly about</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6769.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the issues around the staging of early infection,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6795.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">particularly focusing on HIV, HCV and HBV.  Then, what I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6821.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">will do is briefly address the current issue.  As we have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6848.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">moved to these highly sensitive NAT assays from minipool</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6875.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and considerations of individual donation, the question has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6901.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">arisen as to when infectivity develops in very early</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6927.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">infection.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:6954.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, I will address some of the issues and some of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:6980.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the current studies that are trying to better clarify the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7007.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">relationship between infectivity and RNA during the very</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7034.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">early window phases. Then I will review the international</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:7128.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:7164.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:7840.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:7851.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:7861.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:7872.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7190.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">experience with NAT yield, compiling data from around the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7217.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">world, particularly the whole blood sector, and then close</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7244.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">briefly with just a little bit of discussion about cost</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7270.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">effectiveness, not so much to necessarily move us away from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7296.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the direction in which we are going, which is progressive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7322.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">implementation of these assays, but more to juxtapose the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7349.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">enormous resources we are putting here with what is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7376.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">actually an incredibly difficult problem in other countries</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7402.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">where, in fact, nucleic acid testing could have a dramatic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7429.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">yield. Then, I will finally just mention some of the other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7455.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">research applications that come out of the wide-scale</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7481.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">implementations of NAT screening.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:7508.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:7535.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This slide is one that many of you have seen.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7561.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The only difference is up here, where I have actually added</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7587.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in a series of assays as they have been implemented over</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7613.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the last three decades, moving from the introduction of HIV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7640.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antibody to surrogate tests for hepatitis, to HTLV,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7667.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">progressive improved generation HCV assays, HIV-1,2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7693.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">testing, p24 antigen, HCV-3.0, HTLV-1,2 and finally the NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7719.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">assays, here.  Through the progressive implementation of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7746.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">these enhanced detection, mostly serologic and now nucleic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7772.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">acid assays, we have achieved dramatic reduction in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7799.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">risk for HIV and HCV.  We are now in the range of one in a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7826.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">million.  There is, however, residual risk, as we all know,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:7920.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:7956.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:8632.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:8643.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:8653.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:8664.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:7982.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">particularly in the pre-NAT screening era, and we now</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8009.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">appreciate that the vast majority of this risk comes from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8036.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">window phase donations.  These other concerns around</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8062.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">variant viral strains, chronic antibody negative carriers</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8088.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and errors in testing did exist with serologic tests but</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8114.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have essentially been eliminated with the introduction of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8141.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NAT because NAT really is a redundant system that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8168.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">inherently is able to independently detect these other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8194.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">types of risk sources.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:8221.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, the major focus over the last few years has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8247.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">been on the window period, and as we have struggled to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8273.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">understand the dynamics of early infection and with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8300.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">implementation of NAT and detection of individuals both in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8327.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the plasma and whole blood sector who are viremic and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8353.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">seronegative, we have been able to more carefully study the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8379.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">primary infection phases.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:8405.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:8432.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Through those studies we have defined a series of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8459.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">evolution of phases, beginning with what is termed the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8485.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">eclipse phase, the period of exposure to the first</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8511.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">detectable viremia which seems to last typically for days</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8538.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to weeks.  During this period, we think the viruses are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8564.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">replicating either in liver tissue or in lymphoid tissue in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8591.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the inoculation site before the virus really disseminates</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8618.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">into the plasma.  It is during this period that one cannot</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:8712.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:8748.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:9424.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:9435.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:9445.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:9456.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8774.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">detect viral nucleic acid essentially by definition, and at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8801.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">present most of the risk models assume infectivity exists</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8828.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">during the eclipse period.  We will come back to this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8854.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">because I think recent data suggests that is probably not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8880.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">quite the case, and this may explain why some of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8906.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">current estimates of risk seem to be out of line with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8933.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">regard to the observed residual infections that are taking</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:8960.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">place.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:8986.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">One of the things both our group and several</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9013.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">others, and Dr. Nubling in Germany, have uncovered is a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9039.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">phenomenon called pre-ramp-up viremia which is kind of a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9065.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">smoldering low-level virus with intermittent detection</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9092.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">prior to this exponential increase in viral load to ramp-up</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9119.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">viremia.  For HCV, we know there is a long plateau phase.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9145.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">For most of the other viruses there is peak viremia,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9171.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">followed by a drop in viral load associated with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9197.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">seroconversion.  As I will illustrate, in a number of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9224.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">infections we do see, around the time of seroconversion,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9251.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">dramatic fluctuation in viral load that we term now peri-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9277.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">seroconversion viremia, presumably reflecting the immune</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9303.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">system's effort to try to resolve the infection.  Then,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9330.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">after seroconversion individuals can become persistent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9356.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">carriers or, in the case of hepatitis C or hepatitis B,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9383.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">some do resolve the infection.  There are rare cases that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:9504.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:9540.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:10216.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:10227.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:10237.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:10248.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9566.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have been uncovered, and I will illustrate some, of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9593.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">immunosilent or transient viremia.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:9620.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:9646.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I will quickly buzz through these for each virus.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9672.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is HIV.  As we know, there is a period typically of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9698.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">about ten days from exposure to ramp-up viremia.  There is,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9725.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in some cases, as we have uncovered in collaboration with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9752.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Alpha and NGI, a transient blip phase viremia that seems to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9778.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">occur shortly after exposure.  Then there is the eclipse</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9805.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">period followed by the ramp-up.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:363.90pt;top:9805.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">As we know, depending on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9831.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the sensitivity of the individual minipool p24 antigen, one</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9857.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">can detect this exponential increase in viremia, and then</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9884.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">progressively the detection of antibody by first, improved</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9911.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">second and finally third generation antibody assays.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:9937.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:9963.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Just one illustration of an HIV pre-ramp-up blip</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:9989.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">viremia case, in this case this plasma donor was identified</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10016.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">by minipool NAT screening at what is defined here as day</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10043.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">zero.  At that point their viral load was around 260 and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10069.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">they exponentially increased to ramp-up over the ensuing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10095.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">week.  What was of interest was that as we tested back</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10122.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">samples extending several weeks prior to this ramp-up</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10148.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">phase, we detected a reproducible transient viremia, again,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10175.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">about 20 days prior to this ramp-up viremia.  This was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10202.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reproducible on multiple runs and seems to be a real</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:10296.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:10332.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:11008.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:11019.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:11029.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:11040.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10358.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">phenomenon.  Again, by sequence analysis in one of these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10385.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">cases the virus is identical and highly homogeneous,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10412.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">consistent with exactly what evolved with ramp-up phase,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10438.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">which is probably consistent more with an early replication</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10464.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">phenomenon than the inoculum itself.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:10490.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In all the viruses we have done a lot of work to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10517.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">compile large numbers of ramp-up phase panels that allow us</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10544.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to derive an estimate for the exponential increase, termed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10570.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the doubling time, as illustrated here for HIV.  It is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10597.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">fairly brisk, around 21 hours.  It is this kind of analysis</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10623.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and model that allows us to model the relative detection by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10649.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">minipool versus individual, as I will summarize later.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:10676.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:10703.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">For hepatitis C, there is a different phenomenon</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10729.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in that again there seems to be a pre-seroconversion blip.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10755.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">It is much more intermittent and tends to extend over</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10781.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">periods of weeks and occasionally months.  Then, there is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10808.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this very rapid ramp-up phase, averaging about 17 hours of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10835.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">doubling time.  So, there is a very minimal difference in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10861.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">days to detection between individual and minipool NAT and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10887.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">even the newer HCV antigen tests, as we will hear tomorrow,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10914.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">can detect viremia within days of nucleic acid</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10940.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">detectability.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:10967.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">What is remarkable for HCV is this very</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:10994.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">prolonged, almost two-month high titer plateau phase</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:11088.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:11124.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:11800.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:11811.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:11821.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:11832.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11150.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">viremia.  It is really this viremia that resulted in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11177.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">high level transmission of HCV in the setting of serologic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11204.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">screening, and has translated into a fairly high yield of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11230.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">pooled NAT almost irrespective of pool size.  This is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11256.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">followed by a brief rise in ALT about ten days before</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11282.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antibody conversion, which typically occurs about 70 days</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11309.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">out with the first generation assays but the second and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11336.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">third generation HCV antibody tests had dramatically less</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11362.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sensitivity.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:11389.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:11415.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is just an illustration of an HCV ramp-up</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11441.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">viremia.  In this case, this donor was detected as ramp-up</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11468.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">phase at day zero by, again, NGI minipool NAT and Alpha</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11495.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">panel, followed by the early plateau phase.  This is well</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11521.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">before seroconversion.  Testing back the stored plasma from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11547.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">several months prior to seroconversion demonstrated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11573.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">intermittent detection of HCV RNA.  In this case we used</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11600.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the Gen Probe TMA assay.  Replicate analysis was performed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11627.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">on each of these donations, and what we are showing here is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11653.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the percentage of four replicates that were detected by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11679.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">high input qualitative assay.  You see that we went through</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11706.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">a week here where three or four reps were detected; then</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11732.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the person went negative; then another week where we could</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11759.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">detect the low-level viremia; then negative; then another</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11786.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">blip of viremia.  This was corroborated by NGI PCR well</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:11880.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:11916.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:12592.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:12603.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:12613.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:12624.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11942.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">below the limit of quantitation, so all less than 100</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11969.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">copies.  The contribution of this blip viremia to residual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:11996.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">risk really awaits the determination of the infectivity of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12022.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this phenomenon.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:12048.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:12074.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In terms of the plateau phase in a few outlier</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12101.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">types of cases, this is data from Sue Stramer, the Red</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12128.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Cross experience with bona fide not only yield cases, a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12154.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">total of 35 cases.  These are plotted here by day of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12181.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">first NAT positive, antibody negative donation.  The yellow</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12207.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">portion of each bar represents the period when the donors</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12233.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">were viremic prior to seroconversion.  The red at the end</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12260.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of virtually all these bars represents the date when they</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12287.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">became seropositive.  You can see that these average about</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12313.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">50 days following NAT detection that these donors</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12339.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">seroconverted.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:12365.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I want to focus your attention on these several</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12392.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">outlier cases towards the bottom.  These represent two</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12419.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">individuals who are what we are called immunosilent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12445.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">carriers.  They have been viremic and seronegative.  Each</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12471.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of these hatches represents samples that were corroborated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12498.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to be viremic and seronegative for well over a year in this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12524.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">case and over two years in this case.  So, these are bona</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12551.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">fide immunosilent carriers that we are trying to understand</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12578.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the immunologic basis for.  These are clearly another</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:12672.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:12708.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:13384.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:13395.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:13405.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:13416.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12734.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">contribution of NAT.  These people probably were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12761.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transmitting infection serially, and this has been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12788.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">documented in a case from France where a donor who was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12814.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">persistent seronegative, on look-back follow-up transmitted</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12840.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">infection to a number of recipients.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:12866.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">There are also some unusual cases here where</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12893.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donors were viremic and then went negative for RNA and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12920.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">then, in fact, in one case went negative for virus by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12946.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antibody and RNA and then became viremic again.  So, there</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12973.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">are some unusual intermittent phenomena that we are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:12999.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">uncovering as we implement wide-scale NAT and enroll and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13025.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">follow these donors.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:13052.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:13079.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Just one example of a case of what we are terming</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13105.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">fluctuating viremia around the time of seroconversion.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13131.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This was a donor identified in Florida through the Gen</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13157.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Probe screening system.  This donor was detected as high-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13184.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">level viremic by TMA.  The viral loads have fluctuated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13211.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">around the time prior to seroconversion and, in fact, even</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13237.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">TMA went negative right at the time of seroconversion as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13263.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antibody kicked in.  This is just one example of how viral</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13290.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">load can fluctuate dramatically during the peri-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13316.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">seroconversion phase.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:13316.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:13343.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I will just briefly touch on hepatitis B.  That</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13370.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">will be discussed in more detail by Sue tomorrow.  With</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:13464.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:13500.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:14176.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:14187.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:14197.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:14208.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13526.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HBV, we have also uncovered examples where there is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13553.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">intermittent pre-ramp-up viremia, in this case about two</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13580.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">months, a month and a half prior to antigenemia.  This is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13606.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">surface antigen coming up in yellow.  That is followed by a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13632.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">typical ramp-up phase with viral loads increasing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13658.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">exponentially, a doubling time of about four days for HBV.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:13685.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:13712.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is again a slide from Sue, which she will</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13738.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">focus on but basically illustrating that because the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13765.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">doubling time is relatively slow there is a fairly long</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13791.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">period of about 20 days when you can detect viremia by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13817.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">individual donation NAT before it reaches levels detected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13844.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">by minipool NAT, shown by the line here.  Then, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13871.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">improved antigen assays have substantially reduced the pre-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13897.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antigenemic phase by virtue of detection of lower levels of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13923.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">viremia.  This will be discussed in detail tomorrow in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:13949.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">implications for why we are not doing HBV minipool NAT.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:13976.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:14003.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This slide just summarizes the data from the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14029.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">panels that we have studied.  Again, HCV is unique in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14055.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">having this plateau phase.  The doubling times for each</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14082.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">virus and the frequency of detecting this pre-ramp-up</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14108.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">viremia -- again, we see it in about a third of the HIV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14135.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">cases; a good half or so of the HCV cases and, again, about</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:14256.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:14292.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:14968.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:14979.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:14989.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:15000.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14318.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">half of the HBV cases seem to evidence this intermittent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14345.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">fluctuating viremia during the eclipse phase.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:14372.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:14398.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is just to illustrate that using the viral</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14424.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">load ramp-up dynamics we can then model out the impact of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14450.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reducing the sensitivity or enhancing the sensitivity from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14477.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">minipool to individual or NAT versus antigen, and by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14504.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">knowing the sensitivity of the assays we can derive an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14530.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">estimate for the window period closure one achieves by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14557.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">moving toward a more sensitive test.  It is that window</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14583.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">period closure which, when combined with incidence rates,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14609.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">can estimate the yield of that transition.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:14636.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, as Jay indicated, there continues to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14663.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">interest in moving to individual donation NAT for minipool</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14689.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and this is just an example of what the projected impact</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14715.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">would be of detecting ramp-up viremia, were one to do so,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14741.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">given the model estimates of the window period closure that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14768.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">would be achieved by moving from, for example, pools of 16-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14795.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">24 down to individual samples.  So, what you can see here</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14821.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is that for hep C and HIV, because the viral load ramps up</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14847.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">so quickly, less than a day, the window period closure by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14874.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">enhancing the sensitivity of the assay is about 20-fold.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14900.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">There is only about three to four days.  These viruses have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14927.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">similar incidence rates of about 4/100,000.  So, that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:14954.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">really only translates into a projected two additional</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:15048.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:15084.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:15760.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:15771.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:15781.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:15792.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15110.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">infections detected per ten million donations, which is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15137.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">about the U.S. whole blood collection -- so, fairly modest</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15164.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">improvement with respect to HCV and HIV attributable to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15190.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">going to individual donation.  For HBV, in contrast,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15216.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">because the doubling time is slower, the enhanced window</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15242.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">closure would be more dramatic, about 12 days, and the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15269.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">yield would be a little higher.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:15296.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:15322.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This just briefly summarizes the current</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15349.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">estimates of risk for each virus in the pre-NAT, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15375.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">minipool NAT and the single donation era.  Again, these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15401.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">numbers, expressed both as number of cases detected per</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15428.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">million as well as rates in 1/1.3 million, for example, for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15455.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HIV, all assume that the pre-seroconversion eclipse phase</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15481.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">may be infectious.  Again, I think that is a question we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15507.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">will focus on now, but what you can see is that we have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15533.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">moved from risks in the range of one in a million for HIV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15560.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and one in about 100,000 to about 200,000 for HCV and HBV.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15587.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">As we implement minipool NAT for HIV and HCV those risks</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15613.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have dropped to one in two million or so, and going to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15639.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">individual NAT will drop them a little bit lower, in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15666.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">range of one in three million.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:15692.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:15719.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Again, the question that has been posed, I think,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15746.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">most critically by Mico Leli is whether we are really sure</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:15840.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:15876.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:16552.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:16563.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:16573.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:16584.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15902.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that that pre-ramp-up phase is infectious.  As we have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15929.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">moved from serologic testing or antigen assays to various</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15956.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">pool size sensitivity nucleic acid tests, the question has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:15982.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">been raised as to whether infectivity, in fact, is present</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16008.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">at all of these levels of viremia, and also whether</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16034.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">infectivity may exist even in the pre-ramp-up phase, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16061.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">eclipse phase, and are these blips infectious.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:16088.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:16114.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Toward that end, there have been studies</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16141.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">undertaken, and some others are in progress, to try to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16167.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">better understand this relationship between infectivity and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16193.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">viral load during the pre-seroconversion period.  I am just</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16220.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">going to touch on these for lack of time. The first</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16247.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">approach is to simply take plasma stocks that have been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16273.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">titered out in chimps to define chimp infectivity</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16299.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">concentrations.  By correlating the NAT detection of those</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16325.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">assays, either by doing quantitative viral load on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16352.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">starting stock or by testing, by the qualitative NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16379.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">assays, serial dilutions of these pedigreed stocks, one can</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16405.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">estimate how many genome equivalents correspond to a chimp</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16431.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">infections dose.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:16458.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In those studies, although they are limited, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16484.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the precision of the titration of these panels is limited,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16511.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">they suggest that for HBV and HCV as little as ten genome</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16538.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">equivalents in an inoculum, in the total volume of plasma</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:16632.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:16668.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:17344.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:17355.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:17365.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:17376.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16694.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">introduced into the recipient, would be equivalent to one</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16721.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">chimp infectious dose 50.  So, this suggests that for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16748.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">window phase HBV and HCV extremely infectious and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16774.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">essentially all viral particles probably are capable of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16800.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transmitting, and very low concentrations are able to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16826.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transmit.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:16853.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">For HIV, the chimp model is relatively less</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16880.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">susceptible and there are issues around potential defective</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16906.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">virus.  So, those studies suggest that 1000 to 10,000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16933.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">copies may be required to transmit in the chimp model.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:16959.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Other studies have been undertaken -- this well-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:16985.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">known study by Harvey Alter, where you can infect an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17012.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">animal, and this can be done with chimps and HIV or HCV or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17039.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">with SIV models, for example.  The animal can be infected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17065.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and then sampled serially, plasma and cells, purified and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17091.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">stored away.  Those samples can be characterized by NAT and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17117.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antigen and antibody tests.  Then one can transfuse those</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17144.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">serial samples, stored unit volumes of material from the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17171.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">eclipse phase through the seroconversion phase, in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17197.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">secondary test animals and correlate detection of viremia</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17223.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">with development of antibody.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:17250.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This was a study by Chris Murthy, the first</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17276.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">author, published in </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 12.00pt">Transfusion </FONT></u><FONT STYLE="font-size: 12.00pt">a few years ago, that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17303.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">looked at this for HIV and demonstrated that there was no</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17330.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">ability to transmit until the animal became viremic as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:17424.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:17460.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:18136.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:18147.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:18157.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:18168.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17486.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">detectable by NAT.  So, through the eclipse phase there did</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17513.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">not seem to be infectivity.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:17540.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">One of the concerns though is that the chimp</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17566.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">isn't highly susceptible to primary HIV.  So, in order to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17592.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">further address that, what is going on now are studies</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17618.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">where we are using these plasma donor panels and actually</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17645.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">infusing material from the plasma panels into chimps.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:17672.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:17698.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is, again, a study with Harvey Alter and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17725.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Chris Murthy.  This is just to illustrate the design.  So,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17751.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">we are really trying to understand the phenomenon of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17777.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">blips within the eclipse phase.  So, what we are doing is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17804.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transfusing 50 ml of plasma from each of five donors into</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17831.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">chimps, beginning with samples collected prior to any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17857.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">detectable viremia, any blips or ramp-ups, and then going</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17883.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to the valley between the blips and the ramp-up and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17909.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">following that same animal after a period where we evaluate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17936.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the transition from the initial inocula, following up with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17963.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">inocula from the valley between the blips and the ramp-up.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:17989.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Then, if that does not transmit, moving to the ramp-up</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18015.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">itself to ask is this actually infectious in a chimpanzee.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18042.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">If not, then we will work our way up the ramp-up phase.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18068.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, these studies are currently under way.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:18095.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:18216.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:18252.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:18928.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:18939.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:18949.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:18960.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:18278.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The other approach to understand infectivity is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18305.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to really try to milk, if you will, the human experience</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18332.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that is going on all the time through transfusion.  One</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18358.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">approach is to follow, in essence, donor-directed look-back</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18384.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">strategies where a donor seroconverts to either NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18410.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">positivity or antibody and the recipients are traced</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18437.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">through look-back.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:18464.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Now, there have been a series of cases that have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18490.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">been studied, and I will touch on several of these, that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18517.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reported recipient infection from pre-NAT or pre-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18543.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">seroconversion units and then went back and have studied</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18569.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">these prior donations to ask did they have viremia that we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18596.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">can detect retrospectively.  In a number of countries there</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18623.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">are stored units or there may be recovered plasma off the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18649.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donation.  So, this allows us to really directly ask the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18675.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">question of the relationship between RNA levels and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18701.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">detectable viremia in the human context.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:18728.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Once you have data from a number of these cases,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18755.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">you can then begin to model the duration of the infectious</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18781.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">window period based on the inter-donation interval between</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18807.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the prior donation and the first positive, and compiling</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18834.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the whole data set.  The model for this was first presented</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:18860.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">by Lyle Peterson almost a decade ago.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:18887.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:19008.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:19044.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:19720.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:19731.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:19741.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:19752.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:19070.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Just a few examples.  This is the so-called</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19097.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Singapore case, which was published in JAMA about a year</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19124.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and a half ago.  In this case, a donor seroconverted to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19150.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antibody.  The prior donation was determined and confirmed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19176.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">by molecular methods to have transmitted HIV to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19202.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">recipient.  We obtained that material, the plasma was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19229.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">available, and evaluated that by both the Chiron Gen-Probe</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19256.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and Roche assays, serially diluting the sample to model the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19282.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">pool sizes that were used.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:19309.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">What one can see is that out of the pool sizes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19335.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that are currently employed in the U.S. of 1 to 16 and 1 to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19361.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">24 both assays began to detect the viremia.  This unit was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19388.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">estimated to have about 100 genome equivalents per</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19415.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">milliliter.  So, clear documentation of an HIV.  Although</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19441.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in this example, this was actually prior to NAT screening.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19467.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This was sort of a retrospective study of an HIV antibody</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19493.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">seroconverter where the plasma was available.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:19520.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:19547.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">A second case was reported from Germany, in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19573.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 12.00pt">Lancet</FONT></u><FONT STYLE="font-size: 12.00pt">, where there was an HICV transmission by NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19599.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">negative blood.  Again, a donor seroconverted to HCV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19626.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antibody.  The donation was eight weeks prior.  The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19652.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">platelet transmitted interestingly -- platelets have about</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19679.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">50 ml of plasma, whereas the red cells do not -- only 5 ml</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19706.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of plasma.  The plasma was available and was able to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:19800.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:19836.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:20512.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:20523.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:20533.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:20544.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19862.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">tested.  In the publication it was tested by an enhanced</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19889.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">input PCR that was modeled or projected to have sensitivity</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19916.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">down in the range of 10-30 copies and it was negative.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19942.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Interestingly, we obtained that plasma and were able to run</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19968.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the Gen Probe and NGI assays, and Gen Probe could detect</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:19994.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">virus, qualitative high input analysis, in two of three</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20021.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reps.  So, again, suggesting that an infectious unit for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20048.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HCV could have extremely low levels of viremia, right at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20074.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the limit of detection.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:20101.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:20127.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This case is probably new to most of you.  This</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20153.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">was a recent documented transmission in the U.S.  It</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20180.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">represents, to our knowledge, the first case of HIV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20207.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transmission prospectively identified by NAT screened</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20233.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">blood.  This was identified at the San Antonio blood</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20259.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">center.  In this case, similar to the Singapore case, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20285.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donor seroconverted to antibody two months earlier.  The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20312.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donation that was transfused did infect the recipient.  As</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20339.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I will show you in a moment the genetic studies confirmed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20365.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that this was a linked transmission.  In the same context,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20391.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">we identified the plasma component and have now run the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20418.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">serial dilutions by the two U.S. licensed NAT assays.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20444.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Essentially identical to the Singapore case, in both assays</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20471.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">--</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:148.05pt;top:20471.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">here is the summary -- this sample consistently detected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20498.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">undiluted and high rate of detection at 1 to 8 but at 1 to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:20592.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:20628.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:21304.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:21315.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:21325.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:21336.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20654.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">16, 1 to 24 the assays began to miss this unit -- estimated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20681.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">copy number, again, about 100 genome equivalent.  Clearly,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20708.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transmissions can occur by minipool negative blood but in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20734.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the cases that have been studied aggressively we can detect</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20760.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">viremia in transmission cases.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:20786.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:20813.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This just shows the linkage, the donor and the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20840.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">recipient, both in the envelop and gag regions -- virtually</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20866.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">identical.  So, this is an unequivocal transmission from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20893.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">minipool screened blood.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:20919.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:20945.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">A compilation of data on a larger scale though is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20972.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">really needed to feed a model as Lyle Peterson developed.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:20999.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is probably best illustrated by what Kurt Roth has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21025.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">done in Germany and Austria where, in the setting where</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21051.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">they are doing NAT screening they have rigorously followed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21077.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">all prior donations from seroconverting recipients, by they</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21104.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NAT or antibody seroconverters.  Then, when they follow</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21131.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">those recipients, they determine whether the recipients</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21157.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">were infected and they also have a repository so they can</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21183.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">test the stored donation samples.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:21210.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Interestingly, in this analysis of a number of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21236.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">seroconverters for all three viruses none of the recipients</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21263.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">were infected.  This is important to emphasize.  We tend to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21290.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">focus on these cases where transmission did occur but there</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:21384.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:21420.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:22096.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:22107.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:22117.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:22128.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21446.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">are lots of look-backs that are done where recipients</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21473.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">aren't infected.  Again, in order to get a comprehensive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21500.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">understanding of the infectivity of this window, we really</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21526.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">need to generate data like this that feeds the model with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21552.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">both the transmitting and non-transmitting case data.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:21578.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:21605.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Finally, the other approach to human evaluation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21632.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is when recipients are reported to be infected potentially</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21658.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">by transfusion, and then the donors get investigated, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21685.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">so-called recipient trace back.  Here one can retest</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21711.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">aliquots of the donation plasma from all those donors if</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21737.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">available or recall the donors, and if a transmission does</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21764.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">occur it is important to validate that because we all know</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21791.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">there is a higher level of background infections now than</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21817.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transfusion related.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:21843.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:21869.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I am not going to go through this in detail, but</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21896.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in a study just published in </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 12.00pt">Transfusion</FONT></u><FONT STYLE="font-size: 12.00pt">, the Japanese</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21923.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">investigators did a very rigorous investigation of reported</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21949.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transfusion cases.  They had 103 reported HBV, 92 reported</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:21975.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HCV cases and no reported HIV cases.  The bottom line here</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22002.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">was that of the 103 HBV, only 16 could be determined to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22028.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">really be transfusion related, and most of those would have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22055.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">been detected by either NAT or even contemporary surface</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22082.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antigen assays.  Of the 92 HCV recipient infections</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:22176.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:22212.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:22888.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:22899.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:22909.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:22920.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22238.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">detected, none of them proved to be real.  All of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22265.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donors were negative by NAT and on follow-up.  So, just</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22292.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">again to emphasize that not every case of post-transfusion</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22318.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">hepatitis or HIV really is transfusion determined.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:22344.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:22370.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">With Sue Stramer, just over the last week, we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22397.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sort of canvassed the world about the experience with NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22424.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and this is the whole blood sector yield.  I can make this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22450.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">available to anyone who is interested.  I think there</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22477.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">really needs to be kind of a global collaboration to keep</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22503.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">up to date and compile the NAT yield experience.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:22529.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, what we see here again are the various</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22556.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">countries that have implemented NAT; the pool size</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22583.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">currently employed; the number of units screened in each</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22609.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">region; the number of NAT positives for hep C; and then the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22635.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">yield.  An important observation here is that we seem to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22661.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">see countries like the U.S., Japan and Australia that, with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22688.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HCV, have NAT yields very similar, in the range of 1 in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22715.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">300,000.  Germany and Austria is about 1 in 600,000.  Then</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22741.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">there are a number of countries that seem to have a much</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22767.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">lower rate of NAT detection, in the range of less than one</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22794.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in a million donations.  Some countries, like Holland, 2.4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22820.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">million without a single yield case to date.  So, there is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22847.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">quite a variance in yield, with really the U.S. kind of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:22874.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">driving the high end.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:22968.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:23004.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:23680.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:23691.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:23701.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:23712.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:23030.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:23057.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Here, HIV rates again.  One in about two million</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23084.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in several countries, but then a number of countries again</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23110.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that have yet to have a single detection of an HIV NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23136.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">yield case.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:23162.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:23189.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In trying to understand this variance in yield,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23216.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">we recognize that the model predictions actually may give</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23242.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">us the answer, and the incidence rates model allows us to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23269.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">predict yield.  Toward this end, this is an analysis that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23295.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Sue Stramer just reported at the AABB, where she looked in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23321.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the U.S. at the CDC area division of the United States, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23348.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">broke her donor pool up into a pattern consistent with CDC-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23375.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">defined healthcare regions.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:23401.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">What this slide compares is the HCV incidence,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23427.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">estimated by the anti-HCV frequency in repeat donors,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23453.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">relative to the HCV NAT yield.  One sees the relationship</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23480.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that is actually clarified on this regression map which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23507.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">shows, again, the HCV NAT yield and the incidence rate or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23533.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">anti-HCV prevalence in repeat donors.  One sees a nice</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23559.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">relationship sort of on a micro level within the U.S.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23586.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">itself.  So, we are now trying to get incidence estimates</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23612.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">from these various countries, and we are going to extend</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23639.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this analysis of NAT yield relative to incidence rates to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23666.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">an international perspective.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:23760.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:23796.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:24472.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:24483.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:24493.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:24504.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:23822.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:23849.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Just briefly, a quick mention of cost</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23876.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">effectiveness and kind of issues around the relative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23902.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">benefits of the different NAT target agents.  Importantly -</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23928.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:140.60pt;top:23928.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and this is some work that is going to be coming out in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23954.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 12.00pt">Annals of Internal Medicine </FONT></u><FONT STYLE="font-size: 12.00pt">shortly, if you look at these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:23981.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">various agents, we tend to group them all together and say</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24008.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the yield is this or that, assuming that each one is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24034.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">equally important.  But on a clinical consequence analysis,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24061.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HIV, as we all know, is really a terribly important and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24087.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">pathogenic virus.  So, for every HIV transmission we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24113.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">prevent we actually save the patient society seven quality</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24140.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">life years.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:24167.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Importantly, relatively for HCV one only saves</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24193.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">0.6 quality life years per infection prevented.  One-tenth</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24219.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is important from a clinical prevention perspective.  In</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24245.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HBV one-fifth is as important as HCV.  Again, we know most</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24272.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">people resolve HBV spontaneously.  So, this really fits,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24299.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and it is important to take this into account when we talk</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24325.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">about adding other agent detection -- hepatitis A, parvo-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24351.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">B19 -- because these are even less important clinically for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24378.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the patient.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:24404.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This translates out into the dollars per quality</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24431.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">life years saved.  For example, with HIV we will only</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24458.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">detect about three additional infections by adding minipool</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:24552.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:24588.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:25264.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:25275.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:25285.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:25296.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24614.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NAT and a total of six by going to single donation NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24641.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">relative to HCV, where we are detecting 60 or so per year</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24668.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">with minipool NAT and, yet, the quality saved is virtually</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24694.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">identical.  Again, that is because HIV is much more</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24720.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">important and prevents much more disease by implementing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24746.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NAT.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:24773.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:24800.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I am not going to go through this again.  This is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24826.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">a paper that is in press, but the bottom line is, as we all</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24853.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">know, this is extremely expensive technology with fairly</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24879.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">modest yields.  So, the result is that we are dealing with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24905.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">cost effectiveness in the range of two, three million</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24932.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">dollars per quality life year and we are not going to do</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24959.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">any better by going from minipool NAT with or without HBV;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:24985.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">a little bit of benefit if we can drop some other assays</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25011.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">like antigen and anti-core to offset the cost; and even</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25037.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">going to single donation NAT will still leave us with a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25064.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">technology that is extremely expensive, in the range of two</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25091.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">million dollars per quality life year, and we are spending</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25117.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">just in the U.S. hundreds of millions of dollars to prevent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25143.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">these modest numbers of infections.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:25170.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:25196.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I am sure you can't see this but I just want to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25223.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">juxtapose that with reality.  Unfortunately, in much of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25250.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">world where the incidence of these agents is much greater</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:25344.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:25380.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:26056.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:26067.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:26077.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:26088.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25406.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and, therefore, the benefits of NAT would be dramatic.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25433.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is some data developed with Anton Hanes, in South</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25460.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Africa, where we did what is called the detuned assay on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25486.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">all of the HIV positive donors detected in about a year and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25512.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">a half period.  In South Africa, the prevalence of HIV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25538.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antibody in their donor pool is about 1.2 percent.  They</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25565.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">currently stratify their donor pool into relative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25592.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">prevalence groups, defined by region of the country and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25618.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">race ethnicity parameters, and the high prevalence groups</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25645.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have about a 5 percent prevalence of HIV antibody, whereas</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25671.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">low prevalence groups are at 0.7 percent, almost the same</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25697.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">as in developed countries.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:25724.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:25751.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Now, when we did the detuned assay we could</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25777.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">project incidence rates for each of these different groups.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25803.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">What you can see is that the incidence rate in some</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25829.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">settings, like the high prevalence donors, is 1.9 percent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25856.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">annual incidence -- just an extraordinarily high incidence</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25883.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">rate.  If we then translate that into the window period</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25909.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">yield by adding nucleic acid testing, they would pick up</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25935.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">8/10,000 donations as viremic and seronegative from this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25962.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">high prevalence setting.  As I think we will see later in a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:25988.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">trial that Chiron has done in South Africa, they, indeed,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26015.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have picked up in the range of 1/1000 NAT positive,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26042.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antibody negative donations in this high prevalence</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:26136.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:26172.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:26848.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:26859.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:26869.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:26880.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26198.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">setting.  So, one of the things that I hope this meeting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26225.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">will at least briefly address is the technology transfer of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26252.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">nucleic acid testing so it can become available in these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26278.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">resource-poor countries.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.00pt;top:26278.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:26304.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Finally, my last slide is just to mention that I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26330.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">think the availability of NAT really presents us with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26357.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">important opportunities to contribute to the broader</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26384.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">research agenda around these various infections.  By</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26410.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">identifying large numbers of donors in the plasma and whole</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26437.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">blood screening sector in these very early primary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26463.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">infection stages, we can help characterize the epidemiology</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26489.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of these infections in the broad, general populations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26516.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">looking at incidence trends, the demographics and the risk</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26543.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">factors associated with acquisition of these infections.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:26569.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We can contribute to the molecular surveillance,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26595.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">characterizing the subtypes and the resistance patterns of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26621.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">these newly transmitting strains in the donor pool.  We can</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26648.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">help identify patients and enroll them into pathogenesis</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26675.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">studies, particularly important for both HIV and HCV where</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26701.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">there is enormous interest in better understanding the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26727.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">mechanisms of  control of viremia in early infection,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26754.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">contributing towards development of vaccine strategies or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26780.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">early treatment strategies.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:26807.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">There, again, I think there is just a recent </FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">New</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26834.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 12.00pt">England Journal </FONT></u><FONT STYLE="font-size: 12.00pt">paper on the benefits of early HCV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:26928.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:26964.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:27640.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:27651.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:27661.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:27672.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:26990.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">treatment -- still controversial, but through NAT screening</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27017.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">we are identifying hundreds of people in the viremic pre-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27044.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">seroconversion phase who could then be enrolled into early</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27070.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">treatment trials to evaluate the relative benefit of early</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27096.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">versus delayed treatment, and begin to look not only at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27122.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">early antiviral therapies but immune enhancement</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27149.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">strategies, such as supplemental vaccination or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27176.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">immunomodulatory strategies.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:27202.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, that is the conclusion of my talk.  What I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27229.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have tried to do is to frame the broad issues both in terms</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27255.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of the window period, as well as the yield of NAT and,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27281.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">again, tried to focus a little bit in the end on the cost</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27308.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">effectiveness and the important challenge of bringing this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27335.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">technology to developing countries.  Thank you.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:27361.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. EPSTEIN:  Thank you.  We are running a little</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27387.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">bit late but perhaps one or two questions if there is a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27413.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">burning question.  Yes, Jean-Pierre?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:27440.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. ALLAIN:  Mike, I didn't remember exactly in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27467.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the Schuttler paper, in </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 12.00pt">Lancet</FONT></u><FONT STYLE="font-size: 12.00pt">, whether the individual who</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27493.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">received platelets was significantly or not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27519.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">immunosuppressed.  Because I think in the infectivity</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27546.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">studies the state of the recipient is a complicating factor</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27572.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and that has to be taken into consideration because the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27599.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">same amount of viral copies in an individual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:27720.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:27756.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:28432.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:28443.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:28453.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:28464.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27782.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">immunosuppressed is probably more infectious than in an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27809.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">immunocompetent individual.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:27836.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. BUSCH:  That is an excellent point.  I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27862.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">honestly don't recall either.  It also points out that in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27888.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">many of our populations there are immunosuppressed patients</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27914.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">who could have more prolonged eclipse and early phenomenon.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27941.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, what we are doing with these window period models is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27968.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">really using plasma donors, healthy people, community</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:27994.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">acquired infections.  So, as we are looking at recipients -</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28021.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:140.70pt;top:28021.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">you know, Harvey Alter's ongoing NIH studies -- these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28047.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">recipients are being monitored by nucleic acid tests in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28073.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">addition to serologic methods to be sure we are not missing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28100.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">some transmissions in that setting.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:28127.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. EPSTEIN:  Thank you very much, Mike.  Now I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28153.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">would like to call on Harvey Alter, from the NIH, who will</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28179.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">discuss new hepatitis viruses: Do they make sense?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:183.00pt;top:28205.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">New "Hepatitis" Viruses: Do They Make Sense?</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:28232.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. ALTER:  Well, my talk is a little bit out of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28259.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">order because I have to leave for another meeting.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:28285.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:28311.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, putting these emerging agents at the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28338.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">beginning of this session is like putting the cart before</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28364.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the horse.  If the horse represents me, it is because when</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28391.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">it comes to a test of these agents I am sort of a naysayer.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28418.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">If the cart looks empty, it is because it is hard to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:28512.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:28548.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:29224.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:29235.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:29245.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:29256.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28574.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">interpret the data that I will be presenting.  But I think</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28601.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">it is an interesting group of viruses.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:28628.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:28654.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In any event, I will proceed by saying that my</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28680.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">talk will prove that there is absolutely no substitute for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28706.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">a genuine lack of preparation.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:28733.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Laughter]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:28760.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">When HCV was discovered there was some evidence,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28786.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that I am not going to get into because there isn't time,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28813.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to suggest that there might be additional hepatitis agents,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28839.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">so-called non-ABC agents.  And, the commercial success of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28865.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">hepatitis C testing led companies to pursue the potential</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28892.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of the hepatitis agents.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:28919.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:28945.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The first discovery, if you will, was the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28971.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">resurrection of the GB story.  GB was a surgeon who</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:28997.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">developed acute hepatitis in the 1950's.  His serum was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29024.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transmitted to or put into marmosets and caused hepatitis</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29051.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in the marmoset model.  The marmoset infection could then</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29077.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">be serial passaged to other marmosets.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:29103.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Then a tremendous debate ensued as to whether</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29130.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this was a human hepatitis agent that had been transmitted</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29156.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">or a marmoset agent that had been reactivated.  This was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29183.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">never resolved, but the debate was quite vigorous.  Then</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29210.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this story just kind of died.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:29304.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:29340.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:30016.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:30027.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:30037.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:30048.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:29366.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In the 1990's Abbott resurrected these serial</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29393.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">passage samples from the marmoset and, using new technology</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29420.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of representational difficult analysis, and having pre and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29446.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">post transfusion samples from the marmoset, Abbott</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29472.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">discovered a new agent that they termed GBV-A.  GB, for the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29498.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">surgeon's initials; virus A.  It turns out that GBV-A was a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29525.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">marmoset agent, but as they continued to work they found</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29552.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">GBV-B and eventually then, using the degenerate primers</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29578.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">between these agents and hepatitis C virus, they found GBV-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29605.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">C which is, indeed, a human agent.  And, they showed that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29631.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">GBV-C is transmissible to man and to the chimpanzee.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:29657.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:29684.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Well, simultaneously, Gene Labs found another</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29711.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">agent that was called the hepatitis G virus.  This is the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29737.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">genomic map of the hepatitis G virus.  As you will see, it</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29763.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is very similar to hepatitis C virus because these agents,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29789.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">GBV and HCV and HGV are flaviviruses, very similar to HCV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29816.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">but the one difference is that they seem to lack a core</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29843.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">region.  Otherwise, the non-structural regions and the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29869.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">envelope region seem very similar.  One can speculate that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29895.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">it is the absence of this core region that might attenuate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29922.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the pathogenicity of these agents, but nobody has proven</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29948.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that.  But what was shown is that GVC and HGV are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:29975.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">essentially the same agent, just strain variants of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30002.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">same agent discovered by different companies.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:30096.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:30132.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:30808.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:30819.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:30829.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:30840.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:30158.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:30185.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We then began to look at HGV in particular but</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30212.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the data are interchangeable.  What you find is that in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30238.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">volunteer donor population the rate of viremia was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30264.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">somewhere between one to two percent, and an additional</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30290.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">relatively small number had antibody to HGV.  So, the total</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30317.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">burden in the donor population was not excessively high.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30344.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">But when we went to commercial donors you can see that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30370.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">there was a high rate of viremia, 17 percent; 57 percent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30397.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">had been exposed to these agents.  When you went to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30423.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">intravenous drug use, 15 percent were carriers and 82</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30449.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">percent overall had been exposed.  So, these were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30476.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">parenterally treated donors.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:30503.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:30529.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We then looked at our prospective study of donors</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30555.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and recipients and we found that we only had 13 cases of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30581.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">non-ABC hepatitis in the prospective studies.  Twenty-three</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30608.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">percent of these patients developed an acute HGV infection</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30635.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in the wake of blood transfusion.  However, this rate was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30661.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">not significantly different than the rate of new HGV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30687.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">infections, patients who had minor ALT raises that we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30714.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">didn't really consider post-transfusion hepatitis or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30740.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">patients who had no hepatitis at all.  It looks like more</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30767.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">but the numbers are small and statistically these are not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30794.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">different.  The only difference was that these agents were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:30888.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:30924.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:31600.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:31611.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:31621.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:31632.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30950.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">clearly much higher in the patients who were not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:30977.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transfused.  So, this was a transmissible disease that was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31004.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">not clearly associated with non-ABC hepatitis.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:31030.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:31056.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Overall, we calculated that since the number of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31082.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">hepatitis cases was small and the number of non-hepatitis</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31109.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">cases was very large that even if HGV was a cause of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31136.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">hepatitis, no more than four percent of HGV infections</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31162.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">would have transmitted hepatitis and the vast majority of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31189.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">people who got this infection either had no hepatitis or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31215.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">had coexistent hepatitis C.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:31241.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:31268.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Time is short and I am not going to show you</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31295.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">data, but we then went on to show that we couldn't find</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31321.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this agent in the liver, or the techniques were not good.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31347.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">But we did look at different disease states.  This actually</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31373.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is a study from Thomas and Hadzylannis, in England, and it</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31400.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">showed that the rate of HGV in patients with acute non-AB</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31427.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">hepatitis or chronic hepatitis was relatively low and that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31453.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">it didn't differ from the rate in patients who had immune</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31479.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">hepatitis or alcoholic group of diseases or chronic HBV or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31506.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HCV.  So, there is no specific hepatitis association of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31532.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">these agents.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:31559.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:31680.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:31716.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:32392.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:32403.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:32413.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:32424.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:31742.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, we kind of dropped the HGV story.  It seemed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31769.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">like an unimportant virus.  But just recently there have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31796.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">been two studies reported in </FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The New England Journal of</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31822.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 12.00pt">Medicine</FONT></u><FONT STYLE="font-size: 12.00pt">.  This is the first one from Tillman, in Germany.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31848.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is Michael Monza's group.  For reasons not clear, they</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31874.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">looked at cases of HIV infection and looked at those who</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31901.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">were co-infected with GBV-C in this case, but synonymous</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31928.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">with HCV, and basically showed that if you were infected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31954.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">with HIV and then co-infected with GBV-C your survival was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:31981.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">very significantly improved over patients who had never</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32007.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">been exposed to GBV-C, and intermediate were patients who</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32033.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">had been previously exposed who had antibody to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32060.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">envelope GBV-C or were not viremic.  A very striking</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32087.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">difference.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:32113.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:32139.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">That difference was shown even in patients who</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32165.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">had already developed AIDS, in patients who already had</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32192.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">AIDS.  If you were GBV-C positive your survival was much</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32219.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">longer than patients who were GBV-C negative or had prior</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32245.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">exposure to GBV.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:32271.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:32298.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">One could be skeptical about a finding that one</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32324.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">doesn't expect, but simultaneously Jack Stapleton's group,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32351.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in Iowa, and Dr. Xiang found exactly the same thing in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32378.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">another large HIV cohort.  Patients who were GBV-C/HIV co-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:32472.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:32508.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:33184.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:33195.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:33205.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:33216.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32534.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">infected have a significantly better survival than patients</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32561.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">who were GBV-C negative.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:32588.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:32614.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Stapleton then went on to see if he could figure</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32640.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">out why and they did </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 12.00pt">in vitro </FONT></u><FONT STYLE="font-size: 12.00pt">studies where they used</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32666.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">peripheral blood mononuclear cells and infected them with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32693.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HIV, and then used an infectious clone for GBV-C.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32720.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Basically, what this shows is the six-day production of p24</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32746.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antigen in cultured mononuclear cells.  This would be HIV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32773.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">alone, so a high level p24 antigen; a significantly lower</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32799.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">level of p24 antigen.  This is only about a third of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32825.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">production in patients who were given HGV in cells that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32852.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">were inoculated with HIV and GBV-C simultaneously, or cells</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32879.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that were given HIV first, followed 24 hours later by GBV-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32905.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">C.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:32931.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">What was dramatic is that if the cells were first</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32957.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">infected with GBV-C and then HIV inoculated 24 hours later,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:32984.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">there was a 98 percent reduction in p24 antigen production.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33011.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, there was an </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 12.00pt">in vitro </FONT></u><FONT STYLE="font-size: 12.00pt">inhibition, and this is the mock</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33037.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">infection so it is almost the same as a mock infection.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33063.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">They speculated that somehow GBV-C/HGB was inhibiting the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33090.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">replication of HIV; that it wasn't a matter of cell surface</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33116.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">receptor or entry into the cell; it was a matter of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33143.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">intracellular replication by mechanisms which aren't yet</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33170.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">clear.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:33264.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:33300.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:33976.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:33987.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:33997.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:34008.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:33326.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:33353.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, we have been scratching our heads about this.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33380.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">It doesn't make a lot of sense but it probably is true.  It</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33406.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">may be the production of intracellular cytokines from one</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33432.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">viral agent interfering with another, but we don't really</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33458.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">know at this point.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:33485.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:33512.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">There are a lot of things we don't know, such as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33538.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">why they sterilize needles for lethal injections.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:33565.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Laughter]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:33591.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:33617.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Anyway, that is where the HGV story is right now.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33644.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Subsequently, a Japanese group with Dr. Nishizawa reported</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33671.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">a new agent called TT virus -- TT for the initials of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33697.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">first patient in which this virus was found.  This is three</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33723.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">patients out of five that they studied with post-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33749.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transfusion hepatitis.  Shown here, in blue, are the ALT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33776.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">levels and, in yellow, the level of TT viremia.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:33803.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">What you can see is that post-transfusion there</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33829.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is the appearance of this new agent and a rough correlation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33855.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">with ALT levels, sometimes a very close correlation.  They</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33882.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">suggested that TT was a new agent of post-transfusion</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:33908.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">hepatitis accounting for the non-ABC cases.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:33935.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:34056.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:34092.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:34768.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:34779.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:34789.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:34800.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:34118.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">As it turns out, the characteristics of TTV are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34145.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that it is a very small virus, about 3700 nucleotides.  It</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34172.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is non-envelope so it has proved to be an important agent.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34198.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">It would not be killed by solvent detergent.  It is a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34224.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">single-stranded, circular DNA virus.  It is clearly</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34250.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transmitted parenterally but there is also evidence that it</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34277.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is transmitted fecaly/orally.  And, there is evidence for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34304.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this agent that it does replicate in the liver.  There are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34330.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">now an increasing number of members in this group,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34357.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">including the prototype TTV virus, some later Japanese</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34383.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">isolates named YONBAN and SANBAN, the SEN agent that I will</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34409.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">talk about and many others.  So, this family is now felt to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34436.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">be members of the circoviridae which are classically animal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34463.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and plant viruses.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:34489.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:34515.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The prevalence of TTV is higher than HTV, about</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34541.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">7.5 percent of the volunteer donors in the U.S.  This is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34568.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">patients sampled prior to transfusion, so somewhere between</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34595.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">seven and ten percent of the population is TTV infected.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34621.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">But this was using initial primers.  The Japanese used a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34647.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">more inclusive primer set and found that over 19 percent of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34674.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Japanese donors were TTV infected.  I am sure if we had</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34700.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">used those primers in the U.S. population these numbers</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34727.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">would be higher.  So, it is a very prevalent agent.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:34754.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:34848.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:34884.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:35560.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:35571.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:35581.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:35592.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:34910.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In this study, as we did with HTV, we then looked</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34937.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">at patients who had been prospectively followed post-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34964.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transfusion.  What we found is that among transfused</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:34990.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">patients 26 percent were TTV negative prior to transfusion</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35016.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and developed an acute TTV infection following transfusion.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35042.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This difference was highly significant.  This was highly</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35069.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">significantly different from those who were not transfused,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35096.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">but almost five percent of patients who were not transfused</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35122.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">also acquired a new TTV infection while in the hospital so</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35149.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this has a nosocomial route of transmission that is quite</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35175.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">prevalent.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:35201.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:35228.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I didn't show you on a prior slide to save time</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35255.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that clearly this was a transfusion transmitted disease,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35281.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and we could sequence donor and recipient samples and prove</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35307.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that there was donor-recipient transmission.  But, again,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35333.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the key was to look at the patients who had non-A-to-G</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35360.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">hepatitis versus those who were transfused and had no</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35387.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">hepatitis.  There is absolutely no difference in the rate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35413.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of TTV infection.  The rate in patients who developed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35439.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">hepatitis C appeared higher but it was not significantly</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35466.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">higher, and it is because this group received more blood</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35492.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transfusions.  So, we could show no direct association with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35519.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">post-transfusion of non-ABC hepatitis.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:35546.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:35640.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:35676.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:36352.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:36363.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:36373.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:36384.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:35702.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We looked at patients who had hepatitis C</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35729.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">infection.  There was no impact of coexistent TTV infection</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35756.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">either on the peak of the ALT level or in the rate of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35782.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">chronic HCV infection.  So, these agents were the same; had</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35808.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">no apparent impact on other known hepatitis viruses.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:35834.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:35861.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, this looks like deja-G all over again and we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35888.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">were ready to bury the whole other viruses story when</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35914.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Danieli Primi approached us with still a new agent that he</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35941.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">called SEN, again the initials of the patient, SEN.  He</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35967.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">swore this was not TTV.  He had discovered this agent using</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:35993.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the highly degenerate primers from TTV but felt this was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36020.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">not TTV.  Well, it turns out that SEN is a highly diverse</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36047.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">family.  Shown here in pink is the total diversity of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36073.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">hepatitis C virus.  You can see the diversity of the SEN</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36099.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">family is dramatically more so than HCV.  Members of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36125.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">same family differ from each other by 50 percent in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36152.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">nucleotide sequences.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:36179.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:36205.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I hate to show phylogenetic maps but just quickly</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36231.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to give you the idea that there seemed to be -- and this is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36258.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">from Dr. Tanaka in our own group -- there appear to be four</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36284.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">major groups of these circoviruses.  Here is TTV in group</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36311.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">2.  Here is the YONBAN, the second finding of the Japanese.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36338.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Here is still another Japanese agent called PMV.  Here is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:36432.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:36468.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:37144.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:37155.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:37165.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:37176.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36494.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the SEN family which also includes the Japanese-discovered</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36521.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">agent TUS.  You can see how diverse the SEN family is and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36548.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">how far away it is from TTV.  Yet, these are all</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36574.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">circoviridae and they have similar physical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36600.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">characteristics.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:36626.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:36653.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">When one goes to the same algorithms for SEN, you</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36680.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">find it in low prevalence in the U.S. donor population,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36706.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">volunteer population, about two percent, but very high</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36733.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">prevalence in the Japanese population.  All of these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36759.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">circoviridae are more prevalent, highly more prevalent in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36785.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Japan for reasons which aren't clear.  When you look at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36812.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">parenterally exposed groups where the transfused subjects</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36839.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">are drug users or dialyses patients, again, very high rates</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36865.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of transmission and prevalence.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:36891.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:36917.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The same procedures with SEN came up with a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36944.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">different outcome.  Again, when we looked at transfused</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36971.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">subjects versus non-transfused subjects 30 percent of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:36997.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transfused subjects developed a new SEN infection, again</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37023.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">highly different than the non-transfused subjects but,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37050.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">again, there was a background transmission, a nosocomial</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37076.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transmission even in those not transfused.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:37103.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:37224.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:37260.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:37936.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:37947.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:37957.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:37968.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:37286.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">But the difference was in this slide.  When we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37313.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">looked at 12 of those same 13 cases of post-transfusion</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37340.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">non-ABC hepatitis, 11 out of 12, or 92 percent of them,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37366.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">developed a new SEN infection post transfusion.  We were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37392.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">looking at only two of the SEN agents, SEN-D and SEN-H,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37418.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">because we had previously shown that these agents were in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37445.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">relatively low prevalence of the donor supply and seemed to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37472.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">associate with the hepatitis cases.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:37498.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, we selected the agents that might be most</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37525.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">likely to pay off, and it seemed to pay off in that there</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37551.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">was a high rate of positivity in the hepatitis cases; a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37577.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">significantly lower rate in the non-hepatitis cases, but</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37604.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the rate was still high in patients who didn't get</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37631.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">hepatitis.  Again, because this group was large and this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37657.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">group was small, one could calculate that no more than five</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37683.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">percent of all SEN infections would have been associated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37709.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">with hepatitis.  It was co-associated with hepatitis C</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37736.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">virus, and here is the rate of non-transfused people.  So,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37763.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">we are stuck with a significant association with post-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37789.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transfusion non-ABC hepatitis, but that doesn't necessarily</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37815.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">mean that it is a causal association.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:37842.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:37868.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">When we looked at people with other liver</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37895.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">diseases the rate of SEN infection, the same two agents,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:37922.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">was identical in patients who had non-AB hepatitis.  We</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:38016.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:38052.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:38728.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:38739.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:38749.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:38760.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38078.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">looked at patients with acute liver failure because most of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38105.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">these cases are unexplained.  It doesn't look like SEN is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38132.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the answer to these, and the rates in hepatitis B and C and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38158.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">even non-viral liver disease are all the same.  So, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38184.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">only association of these SEN agents with hepatitis is that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38210.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">they were found in a very high rate in this particular</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38237.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">group of post-transfusion cases.  We are waiting for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38264.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">analysis of the TTV study that Blaine Hollinger is doing to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38290.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">see if a similar finding will be forthcoming in that study.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:38317.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:38343.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In conclusion, we don't really know what these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38369.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">agents mean.  Despite the fact that we found these cases, I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38396.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">don't really think this was the cause of their hepatitis.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38423.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I think it is somehow an artifact of our selection process,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38449.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">but it is very hard to rule that out.  We are going to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38475.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">discover molecular agents.  The sensitivity of our</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38501.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">techniques is so high now that we will continue to discover</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38528.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">new agents, and there are three possibilities for these new</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38555.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">agents.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:38581.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">One is that they are not pathogenic; that these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38607.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">really represent commensal agents or, if you will, a normal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38634.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">viral flora.  Perhaps these agents have other purposes.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38660.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Perhaps they are there for evolutionary purposes.  So, that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38687.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is one possibility.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:38808.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:38844.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:39520.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:39531.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:39541.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:39552.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:38870.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Secondly, it is possible that most members of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38897.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">these families are benign; that there may be some variants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38924.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that cause disease of the liver, as perhaps in DNH, but</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38950.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">also of other organs.  There are many unexplained diseases.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:38976.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Are these an agent of some unexplained disease?  There is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39002.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">no evidence for that as yet.  But it is difficult to study</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39029.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this because the prevalence is so high.  You have to find</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39056.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this enormously high association with a disease to work on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39082.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">causality.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:39109.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Lastly, they may cause disease only in persons</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39135.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">who are uniquely susceptible, either genetically</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39161.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">susceptible or by immune deficiency or by some other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39188.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">susceptibility factor.  Thus far there is no evidence for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39215.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this and they don't appear to cause more disease in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39241.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">patients, like HIV-infected patients.  But it is very</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39267.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">difficult to prove any one of these three hypothesis.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:39293.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:39320.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">But we are working on it and, as a government</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39347.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">worker, I want you to know that I give a hundred percent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39373.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">effort to whatever I do.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:39399.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Laughter]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:39426.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We have distributed funding and today happens to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39452.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">be a 23 percent day so you are getting a pretty good</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39479.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">effort.  Thank you very much.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:39600.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:39636.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:40312.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:40323.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:40333.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:40344.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:39662.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. EPSTEIN:  Harvey, thank you.  That was both</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39689.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">informative and entertaining.  Again, one or two questions.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39716.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Steve?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:39742.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. KLEINMAN:  Steve Kleinman.  Harvey, I know</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39768.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">some years ago you reported CMV hepatitis in your patients.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39794.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">You know, maybe that is an analogy for SENV where it is a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39821.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">virus that really doesn't cause hepatitis in most people</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39848.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and, if it does, it can just cause mild hepatitis and, in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39874.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">fact, you don't see any chronic sequelae because it is a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39901.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">rare event and it is really clinically not a very</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39927.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">significant event.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:39953.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. ALTER:  Yes.  When I grew up, that was a $64</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:39980.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">dollar question; now it is a 64 million dollar question.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40007.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">It is hard to rule out the possibility that it only causes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40033.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">disease in an occasional patient or even that it causes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40059.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">diseases that we are not looking for right now.  There is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40085.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">no evidence now that we should be testing.  But the counter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40112.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">argument is always, "well, what if?"  What if it might do</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40139.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">something.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:40165.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. KLEINMAN:  But not even going there, just to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40191.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the extent that you have a clinical finding that you need</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40218.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to explain and you can explain it as an unusual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40244.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">manifestation of this viral infection that isn't very</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40271.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">clinically significant.  I mean, that is why you get CMV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:40392.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:40428.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:41104.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:41115.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:41125.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:41136.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40454.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">hepatitis; it happens but nobody really thinks of CMV as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40481.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">being a hepatitis agent.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:40508.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. ALTER:  Well, you do know that hepatitis is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40534.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">part of the CMV story and in some people it can</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40560.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">predominate.  So, there is a little difference but I can't</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40586.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">rule it out.  That is why we have been reluctant to give up</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40613.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">on these viruses, because there may be something there.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40640.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">They could be a very interesting class of viruses, and why</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40666.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">do we have all these viruses in our body?  That is what</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40693.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">intrigues me.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:40719.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. EPSTEIN:  I don't think we should give up on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40745.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">viruses that haven't given up on us.  Any other questions?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40772.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">No?  Thank you again.  We are going to move on to our next</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40799.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">set of speakers on the topic of regulatory issues and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40825.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">perspectives, and Dr. Paul Mied will first talk about the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40851.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">FDA agenda on implementation of NAT for hepatitis C and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:40877.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HIV.  Paul?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:204.75pt;top:40904.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I.  Regulatory Issues and Perspectives</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:179.25pt;top:40930.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">US FDA: Implementation of NAT for HCV and HIV</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:40957.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. MIED:  Thank you, Dr. Epstein.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:40983.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:41010.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This morning I would like to briefly outline for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41036.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">you FDA's current thinking on implementation of NAT on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41063.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">pooled source plasma and whole blood samples, HIV RNA and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41090.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HCV RNA.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:41184.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:41220.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:41896.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:41907.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:41917.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:41928.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:41246.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:41273.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">By way of background, let me discuss some FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41300.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">perspectives that were summarized, the recent history and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41326.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the current regulatory status of pooled sample NAT.  Back</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41352.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in September of 1994, we held a workshop to discuss the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41378.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">potential application of nucleic acid based methods to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41405.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">screening of blood and plasma donations for HIV.  It was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41432.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">felt at that time that although these methods were clearly</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41458.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sensitive, they were not ready for implementation on a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41485.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">large scale.  But the industry actively pursued the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41511.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">development of NAT for screening blood and plasma donors.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41537.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Due to the cost and labor intensiveness of NAT, there was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41564.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">much interest in testing pools of plasma samples, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41591.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">minipools by NAT.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:41617.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">By 1997, some manufacturers in Europe had</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41643.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">voluntarily instituted NAT on minipools.  About that time,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41669.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the European Union issued a directive, and this directive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41696.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">stated that by July 1, 1999 HCV RNA testing would be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41723.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">required in Europe for all plasma for fractionation, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41749.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that the requirement for HIV-1 RNA testing would follow at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41775.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">a later date.  In the United States NAT or minipools were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41802.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">first introduced as an in-process control test for plasma</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:41828.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for fractionation.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:41855.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:41976.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:42012.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:42688.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:42699.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:42709.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:42720.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:42038.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">However, the European directive and our own</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42065.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">position at that time that pooled sample testing by NAT for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42092.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HIV or HCV constituted a form of donor screening provided</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42118.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">impetus for the rapid development of NAT for all blood and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42144.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">plasma donations.  We have taken the position that NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42170.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">tests used to screen blood and plasma for HIV RNA and HCV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42197.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">RNA are subject to regulation as biological products under</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42224.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the licensing mechanism.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:42250.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NAT screening of blood and plasma donations was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42277.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">expected to improve blood safety while not interfering with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42303.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">current measures of safety.  Therefore, we permitted the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42329.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">clinical study of this investigational technology on a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42356.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">large scale under IND.  Such large-scale studies were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42383.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">necessary to demonstrate the efficacy of NAT in further</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42409.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reducing the residual risk of infectious disease</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42435.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transmission primarily because of the low frequency of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42461.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">window period donations.  Testing of pooled specimens</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42488.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">rather than single donations was identified as a preferred</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42515.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">format due to the technical state of the development of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42541.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NAT.  Test kit manufacturers and testing laboratories</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42567.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">submitted INDs describing their test method and validation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42594.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">at the preclinical level.  Blood organizations and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42620.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">establishments intending to use the assay for donor</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42647.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">screening also filed INDs to describe their clinical trial</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42674.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">protocol for validation of pooled sample NAT. So, donor</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:42768.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:42804.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:43480.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:43491.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:43501.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:43512.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42830.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">screening by NAT for HIV and HCV on pooled specimens was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42857.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">implemented nationwide under the IND mechanism.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:42884.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:42910.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">On November 26, 1999 FDA published a draft</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42936.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">guidance for industry application of current statutory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42962.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">authority to nucleic acid testing of pooled plasma.  In</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:42989.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this guidance document we provided industry with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43016.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">alternative pathways for regulatory approval of pooled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43042.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sample NAT tests for HIV and HCV to screen blood and plasma</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43069.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donations.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:43095.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">On December 14, 1999 we published a guidance for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43121.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">industry on the validation of NAT methods to screen plasma</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43148.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donors in the manufacture and clinical evaluation of </FONT></FONT><u><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43175.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><u><FONT STYLE="font-size: 12.00pt">vitro </FONT></u><FONT STYLE="font-size: 12.00pt">tests to detect nucleic acid sequences of HIV-1 and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43201.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">2.  This document provided guidance on manufacturing and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43227.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">clinical trials to obtain licensure of the test method for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43253.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">use in donor screening for transfusion-transmitted viruses.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43280.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In this document FDA also discussed standards for NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43307.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">methods used to test pooled plasma.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:43333.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:43359.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">As Dr. Epstein mentioned, on September 18, 2001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43386.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">FDA licensed the first NAT system.  This is the NGI</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43412.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">UltraQual HIV-1 and HCV RT-PCR assays.  These assays are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43439.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">performed in-house by NGI.  And, Alpha Therapeutic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43466.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Corporation was licensed to use the NGI assays for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:43560.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:43596.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:44272.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:44283.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:44293.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:44304.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43622.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">qualitative testing of pooled samples from donors of source</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43649.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">plasma.  I should mention that data collected by NGI under</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43676.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">IND and submitted in their license application demonstrated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43702.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that the licensed NGI HIV NAT method is sufficiently</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43728.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sensitive to replace p24 antigen screening of pooled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43754.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">samples of source plasma.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:43781.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Also as Dr. Epstein mentioned, at the present</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43808.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">time nearly all source plasma and whole blood collected in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43834.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the U.S. are tested for HIV-1 RNA and HCV RNA, and this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43861.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">testing is being done using the licensed NGI pooled sample</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43887.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NAT method or under an approved IND for pooled sample NAT.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:43913.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Now that a NAT method has been licensed, I am</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43940.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">going to outline FDA's current thinking on NAT testing,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43967.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">product management and donor management using a licensed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:43993.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">method for NAT on pooled source plasma or whole blood</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44019.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">samples for HIV RNA and HCV RNA.  FDA intends that these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44045.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">elements of our current thinking form the basis for a draft</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44072.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">guidance document in the near future that provides</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44099.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">recommendations to blood and plasma establishments,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44125.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">manufacturers and testing laboratories that are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44151.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">implementing a licensed NAT method.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:44178.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">At the March, 2001 meeting of the Blood Products</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44204.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Advisory Committee FDA proposed uniform algorithms for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44231.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">management of whole blood and source plasma donations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44258.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">tested by pooled sample NAT and a multiplex test for both</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:44352.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:44388.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:45064.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:45075.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:45085.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:45096.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44414.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HIV RNA and HCV RNA.  If a reactive net result is obtained</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44441.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for a master pool, it is appropriate to perform subsequent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44468.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">testing to identify the individual unit that is positive as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44494.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the basis for the reactive result on the pool.  The focus</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44520.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of the FDA proposed algorithms was the action that should</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44546.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">be taken in the event of discrepant testing results, such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44573.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">as when the master pool was reactive but individual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44600.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donations are then found to be non-reactive.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:44626.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Data generated using NAT under IND showed that in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44653.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">each discrepant case it was the master pool that was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44679.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">falsely reactive.  This was due to contamination either</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44705.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">during specimen handling or during the assay run.  False</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44732.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">negatives on individual donations have not been seen in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44759.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">studies performed using various NAT methods under IND.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:44785.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The Blood Products Advisory Committee felt that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44811.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in each case in which there was a discrepancy between the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44837.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">master pool reactive NAT result and the negative NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44864.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">results on individual donations, the negative NAT result on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44891.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">individual donations should be considered the definitive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44917.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">test result.  Therefore, units could be released on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:44943.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">basis of the individual donation test results.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:44970.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:44996.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This first algorithm is likely to be used by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45023.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">establishments testing smaller pools, for example, pools of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45050.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">16 or 24 samples from whole blood or source plasma</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:45144.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:45180.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:45856.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:45867.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:45877.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:45888.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45206.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donations.  Those establishments would most likely prefer</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45233.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to directly test all individual donations from which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45260.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">samples were originally pooled to make the NAT reactive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45286.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">master pool.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:45312.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Now, if you are one of those blood</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45338.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">establishments, you should test the individual donations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45365.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">using the same NAT method -- primers, probes, etc. -- that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45392.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">was used in the original NAT on the original master pool.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45418.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">If one or more of those individual donations is reactive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45445.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">you may release the non-reactive donations provided</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45471.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">serologic tests on those donations are negative.  You</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45497.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">should discard the reactive donation, defer the donor</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45524.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">indefinitely, and test the reactive donation using a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45551.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">discriminatory NAT.  That is essentially the same NAT test</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45577.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for the RNA of the individual viruses.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:45603.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">If the discriminatory NAT is positive for HIV RNA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45629.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">or HCV RNA, you should notify and counsel the donor</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45656.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">regarding the meaning of the test result and the need for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45683.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">medical referral so that follow-up testing may be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45709.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">performed.  You should also perform look-back for HIV or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45735.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HCV to identify prior donations from that donor made within</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45762.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">a certain time period.  False-positive NAT results have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45788.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">been known to occur.  Therefore, the donor may be eligible</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45815.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for reentry depending upon serological test results and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:45842.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">other criteria.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:45936.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:45972.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:46648.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:46659.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:46669.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:46680.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:45998.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">If the donation is negative for both HIV RNA and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46025.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HCV RNA, you should test the donation using an additional</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46052.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NAT.  That is a NAT that uses an amplification technology</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46078.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and/or primers that are different from those that were used</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46104.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in the original NAT on the master pool.  If the additional</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46130.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NAT is positive, you should defer the donor permanently;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46157.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">notify or refer the donor for medical follow-up and perform</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46184.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">look-back for HIV or HCV.  If the additional NAT is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46210.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">negative, you should notify and appropriately counsel the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46237.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donor, and that donor may be eligible for reentry.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:46263.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">On the other hand, if all individual donations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46289.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">are non-reactive, our current thinking is to permit the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46316.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">release of all donations provided, of course, serologic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46343.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">tests for HIV and HCV on those donations are negative.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46369.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">However, as part of an overall quality assurance program,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46395.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">we encourage you to conduct additional testing to determine</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46421.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the cause of the initial reactivity of the master pool.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:46448.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:46475.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The second alternative algorithm is more likely</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46501.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to be used by source plasma establishments that prefer to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46527.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">perform a deconstruction of the master pool that contains a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46554.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">larger number of donations by testing archived or freshly</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46580.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">pooled subpools to identify the reactive individual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46607.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donation.  You should test the archived or freshly made</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46634.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">subpools using the same NAT method -- primers, probes, etc.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:46728.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:46764.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:47440.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:47451.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:47461.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:47472.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46790.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">--</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:148.20pt;top:46790.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that was used in the original NAT on the master pool.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46817.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This deconstruction of the master pool to determine the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46844.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">basis for the reactivity may actually involve several</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46870.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">layers of testing using archived or freshly pooled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46896.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">subpools.  If one or more of the subpools is reactive, you</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46922.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">may release the donations that comprise the non-reactive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46949.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">subpools provided, of course, serologic tests on those</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:46976.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donations are negative.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:47002.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">You should test the individual donations that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47029.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">comprise the reactive subpool using the same NAT method</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47055.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that was used in the original NAT on the master pool.  If</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47081.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">one or more of the individual donations is reactive, you</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47108.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">may release the non-reactive donations provided, of course,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47135.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that serologic tests on those donations are negative.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:47161.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">You should discard the reactive donation; defer</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47187.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the donor indefinitely; and test the reactive donation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47213.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">using a discriminatory NAT.  The rest of the algorithm is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47240.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the same as the first algorithm that went directly from the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47267.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">master pool to testing of individual donations.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:47293.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">On the other hand, if all subpools are non-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47319.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reactive, our current thinking is to permit the release of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47346.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">all donations that comprise the non-reactive subpools</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47372.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">provided, of course, that serologic tests for HIV and HCV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47399.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">on all donations in those subpools are negative.  However,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47426.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">as before, as part of an overall quality assurance program,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:47520.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:47556.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:48232.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:48243.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:48253.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:48264.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47582.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">we encourage you to conduct additional testing to determine</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47609.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the cause of the initial reactivity of the master pool.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:47636.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:47662.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">FDA's current thinking is to include</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47688.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">recommendations for donor reentry into a draft guidance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47714.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">document on NAT implementation.  We are also considering</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47741.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">using that draft guidance to update the reentry algorithms</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47768.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for donors deferred because of serologic HIV or HCV test</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47794.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">results since the reentry procedures for those donors</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47821.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">should also integrate both NAT and serology test results.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:47847.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We are considering recommending that three groups</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47873.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of donors, deferred because of HIV test results, be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47900.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">considered for reentry.  The first group consists of donors</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47927.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">who had NAT reactive results but were seronegative, those</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47953.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">we just talked about.  The HIV discriminatory NAT may have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:47979.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">been either positive or negative but if an additional NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48005.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">was performed, a NAT that uses amplification technology</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48032.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and/or primers that are different from those that were used</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48059.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in the original NAT method on the master pool, that test</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48085.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">must have been negative.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:48111.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The second and third groups consist of donors</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48138.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">with negative NAT who have a repeatedly reactive screening</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48164.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">test for HIV antibody and negative or indeterminate HIV-1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48191.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Western Blot or IFA results on the index sample, or who</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48218.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have a repeatedly reactive EIA for HIV-1 p24 antigen with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:48312.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:48348.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:49024.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:49035.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:49045.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:49056.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48374.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">an indeterminant, that is, an invalid or non-neutralized</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48401.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">result on the neutralization test.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:48428.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">For all three groups of donors deferred because</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48454.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of HIV NAT or HIV antibody or antigen test results, we are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48480.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">considering recommending that a follow-up sample be taken</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48506.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">after a minimum time period of eight weeks for follow-up</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48533.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">testing of the donor by both a licensed HIV NAT and a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48560.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">licensed HIV antibody EIA.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:48586.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Data that we saw presented at the June, 2001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48613.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Blood Products Advisory Committee meeting demonstrated that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48639.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">an eight-week follow-up period encompasses the pre-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48665.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">seroconversion window period for HIV with sufficient</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48692.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">confidence that negative serology tests after at least</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48719.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">eight weeks have passed rule out HIV infection.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:48745.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">If you wish to perform follow-up testing on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48771.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donor prior to the end of this eight-week period, you may</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48797.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">do so for donor notification purposes or for medical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48824.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reasons.  However, if you again obtain a NAT reactive or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48851.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">repeatedly reactive antigen or antibody test result during</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48877.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this eight-week deferral period you should permanently</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48903.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">defer the donor.  You may use negative results on the HIV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48930.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">tests prior to the end of this eight-week period and donor</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48956.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">counseling, however, only a negative screening test result,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:48983.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">obtained at least eight weeks after the repeatedly reactive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:49104.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:49140.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:49816.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:49827.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:49837.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:49848.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49166.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">result on the index donation, qualifies as the test of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49193.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">record for purposes of donor reentry.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:49220.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I should also add that to alleviate the concern</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49246.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">about the inappropriate entry of a donor infected with HIV-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49272.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">1 group O or an HIV-1 variant, the testing on the follow-up</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49298.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sample from the donor should include a licensed HIV NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49325.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">method that is labeled sensitive for HIV-1 group O and HIV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49352.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">group M variants.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:49378.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In addition, the anti-HIV-1,2 EIA test performed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49405.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">on the follow-up sample should be the original EIA test for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49431.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HIV-1 and HIV-2 that was run on the index donation, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49457.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">there could be an alternate EIA that also an HIV-2 test and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49484.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is labeled sensitive for HIV-1 group O.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:49511.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:49537.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In the absence of evidence for seroconversion,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49563.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that is, if the anti-HIV EIA is negative, a negative NAT on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49589.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">follow-up testing at least eight weeks later may be taken</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49616.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">as evidence that any previous reactive NAT result on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49643.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">index donation that was not confirmed by a reactive result</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49669.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">on additional NAT was, in fact, an error.  If both the NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49695.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and EIA tests on the follow-up sample are negative, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49722.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donor may be reentered, that is, becomes eligible for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49748.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">future donation.  A donation taken at a later date would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49775.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">then be tested using the usual battery of screening tests.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49802.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Thus, two NAT tests and two EIA tests would be performed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:49896.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:49932.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:50608.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:50619.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:50629.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:50640.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49958.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and must be negative before a unit from that donor could be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:49985.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">used.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:50012.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:50038.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">FDA's current thinking is to also include in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50064.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">future draft guidance document a recommendation that two</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50090.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">groups of donors, deferred because of HCV test results, be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50117.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">considered for reentry.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:50144.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The first group consists of donors who had a NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50170.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reactive result but were seronegative, those we already</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50197.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">talked about.  The HIV, HCV discriminatory NAT may have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50223.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">been either positive or negative, but if an additional NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50249.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">was performed it must have been negative.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:50276.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The second group of donors consists of donors</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50303.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">with a negative NAT who have repeatedly reactive screening</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50329.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">tests for anti-HCV antibody, with negative or indeterminate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50355.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">label results on the index sample.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:50381.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">As we have already heard this morning from Dr.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50408.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Busch, our current research indicates that detectable</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50435.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">viremia may be intermittent and may also be resolved in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50461.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">about 20 percent of cases of HCV infection.  For purposes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50487.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of NAT possible HCV viremia, optionally you may follow-up</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50514.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the deferred donor with an HCV NAT and an anti-HCV EIA test</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50540.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">at any time up to six months after the index donation, for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50567.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">example, eight weeks later.  A reactive HCV NAT or positive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50594.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HCV antibody test result would exclude the possibility of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:50688.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:50724.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:51400.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:51411.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:51421.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:51432.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50750.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reentry for that donor.  If that NAT test is non-reactive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50777.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and HCV antibody testing is not positive, the donor should</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50804.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">be follow-up with another HCV NAT and an anti-HCV EIA at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50830.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">least six months after the index donation to qualify the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50856.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donor for reentry.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:50882.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The data that we saw presented at the June, 2001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50909.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Blood Products Advisory Committee meeting demonstrated that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50936.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">a six-month follow-up period encompasses the pre-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50962.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">seroconversion window period with sufficient confidence</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:50989.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that a negative HCV serology test, after at least six</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51015.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">months have passed, rules out HCV infection.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:51041.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:51068.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Therefore, for purposes of reentry we are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51095.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">considering recommending that a follow-up sample be taken</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51121.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">after a minimum time period of six months for follow-up</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51147.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">testing of the donor by both a licensed HCV NAT and a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51173.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">licensed anti-HCV EIA.  If both the NAT and EIA tests on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51200.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the follow-up sample are negative, the donor may be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51227.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reentered, that is, would be eligible for future donation.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:51253.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, I think I will stop there and take any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51279.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">questions you might have.  Yes, Dr. Schochetman?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:51306.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. SCHOCHETMAN:  Gerry Schochetman.  I just</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51332.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">wanted to mention a case we came across of somebody who was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51359.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HIV EI positive and full-blown Western Blot positive but</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51386.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">RNA negative by multiple tests.  The only way we were able</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:51480.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:51516.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:52192.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:52203.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:52213.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:52224.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51542.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to confirm that was by collecting some PBMCs and showing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51569.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that there was a low level of proviral DNA, which we could</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51596.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sequence and show that the individual was a subtype B.  So,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51622.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">there may be another kind of case where somebody may be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51648.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">continuously NAT RNA negative but could actually be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51674.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">infected.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:51701.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. MEID:  Right.  Of course, those donors would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51728.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">not be reenterable because of the persistent antibody.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:51754.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. EPSTEIN:  Now we are going to expand the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51781.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">perspective to look across the pond and hear a talk from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51807.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Micha Nubling, from the Paul Ehrlich Institute, also on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51833.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">regulatory issues and perspectives.  Thank you very much.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:172.50pt;top:51859.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Paul Ehrlich Institute and European Union Views</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:51887.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:51913.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. NUBLING:  First of all, I would like to thank</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51939.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the organizers for the opportunity to speak here and to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51965.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">present the views of PEI.  I will also present the views of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:51992.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the EU on plasma derivatives.  Glenda Sylvester was invited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52019.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">as well but couldn't come and, therefore, I took over her</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52045.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">presentation as well.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:52071.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:52098.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Blood components are estimated as drugs according</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52124.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to the German Drug Rule and, therefore, respective</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52151.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">regulations are possible and the responsible party is the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52178.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">PEI.  Several years ago, or two years ago, HCV-NAT was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:52272.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:52308.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:52984.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:52995.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:53005.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:53016.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52334.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">introduced.  I will cover this shortly.  Then I will go to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52361.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">comparative studies concerning HCV co-antigen.  The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52388.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">question was if this assay could replace or substitute at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52414.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">least HCV NAT.  Then I will come shortly to HIV and our</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52440.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">plans to introduce this also as screening for whole blood</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52466.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">components in Germany.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:52493.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:52520.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is already history.  The regulation for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52546.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">blood components HCV NAT was introduced as a screening test</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52573.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for erythrocytes and thrombocytes and later also for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52599.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">seropoeitic plasma by PEI, already in April of 1999.  At</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52625.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this time we defined a sensitivity limit which was to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52652.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">fulfilled of 5000 international units per milliliter and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52679.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this was to be controlled by run controls.  Pooling, of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52705.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">course, was possible with this requirement and, at this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52731.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">time, there was no commercial assay available so also in-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52757.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">house tests were to be accepted as long as they fulfilled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52784.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">validation requirements, which we defined also at PEI.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:52811.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The meantime experience with this requirement is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52837.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that it is feasible, but we also have to say that the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52863.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">experience benefit is somewhat lower than expectations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52890.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">based on incidence data which I provided two years ago.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52916.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">But I also have to say that the basis for the incidence</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:52943.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">data is quite different in some blood banks where repeat</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:53064.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:53100.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:53776.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:53787.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:53797.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:53808.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53126.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reactive donations go into incidence calculations.  This</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53153.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">might also be a reason for this discrepancy.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:53180.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:53206.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In numbers, we have had a recent presentation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53232.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">from Prof. Seifried and Hitzler at the IABS meeting with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53258.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the most recent data, and we see some discrepancy between</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53285.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">different organizations which collect blood in Germany.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53312.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The smaller donations and less associated with universities</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53338.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">or small hospitals have a higher frequency of NAT only</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53365.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">positive donations, approximately 7.3 per million, while</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53391.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the Red Cross blood donations have quite a lower frequency,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53417.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">approximately a factor of ten.  This is probably due to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53444.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">different populations, donor populations because these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53471.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donor populations came mainly from cities while the Red</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53497.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Cross blood donations cover mainly rural areas in Germany.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:53523.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We have also addressed incidence.  Viral</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53549.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transmissions have to be reported to EPI by an installed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53576.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reporting system, and since this NAT regulation has been in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53603.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">place there has been no adverse incidence reported of HCV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53629.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transmission by blood.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:53655.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:53682.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, this is the experience and the benefit which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53708.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is obtained in the meantime.  Approximately three years ago</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53735.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the antibody to HCV for antigen ELISA became available and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53762.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">immediately the question was if this test could be used</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:53856.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:53892.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:54568.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:54579.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:54589.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:54600.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53918.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">also for screening in addition to HCV NAT or even replacing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53945.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HCV NAT, and I just want to summarize some studies we have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:53972.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">performed in this respect.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:53998.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We had access to 52 follow-ups of the very early</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54024.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">infection phase, similar to the follow-ups Michael Busch</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54050.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">already reported, covering in total nearly 500 anti-HCV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54077.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">negative window phase samples.  We analyzed all these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54104.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">samples by different NAT methods and also by the core</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54130.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antigen and also we genotyped the different panels.  I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54157.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">would like to shortly summarize the data.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:54183.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:54209.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In blue you always see the core antigen ELISA.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54236.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Here is the cut-off value.  In red is the HCV RNA.  So,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54263.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">here is the run-up phase, as was already introduced by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54289.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Michael Busch.  We see it as parallel HCV detection in 10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54315.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">out of the 52 panels where there is no difference between</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54341.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">these two assays.  So, the first PCR positive assay sample</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54368.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is also antigen positive.  This was for 10 of 52 panels.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:54395.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:54421.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">For 21 of 52 panels we see the following pattern,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54447.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">also represented by only one panel, of course.  There is a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54474.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">delay of antigen detection, approximately one week.  Later</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54500.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">on there is a consistent detection of HCV RNA and core</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54527.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antigen.  We also see these blips or these low titer</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54554.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">viremia samples in many of these panels.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:54648.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:54684.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:55360.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:55371.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:55381.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:55392.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:54710.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:54737.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The last pattern which I want to share with you</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54764.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is fluctuating antigen detection.  Again, there is a steep</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54790.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">increase in HCV RNA and the second sample is also core</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54816.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antigen positive.  But later on there is again a decrease</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54842.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in HCV RNA titer and this is followed by core antigen</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54869.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">negative results and borderline results.  This pattern we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54896.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">see in 9 out of 52 panels.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:54922.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:54949.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, summarizing these data again, the red columns</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:54975.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">represent the severe RNA.  The blue columns represent core</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55001.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antigen.  We have grouped the different columns in respect</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55028.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to increasing HCV RNA titers.  We see immediately that the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55055.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">high titer RNA samples are also detected by the core</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55081.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antigen test very consistently, but approximately at 10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:522.75pt;top:55079.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55107.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">units per milliliter and lower the core antigen test</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55133.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">becomes negative while NAT remains positive.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:55160.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I have to admit that with the requirement which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55187.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is in place in Germany there would also be certain low</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55213.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">titer samples missed.  This are the blip samples again.  A</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55239.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">few low titer samples would be missed and, therefore, it is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55266.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">under discussion if this sensitivity requirement should be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55292.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">changed to higher sensitivity.  We can also calculate the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55319.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HCV RNA doubling time.  It is a slightly different figure</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55346.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">compared to Michael Busch's but maybe the analysis did not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:55440.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:55476.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:56152.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:56163.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:56173.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:56184.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55502.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">use the same panels and not the same algorithm.  With this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55529.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HCV RNA doubling time during the virus burst we can also</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55556.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">calculate effects.  If the sensitivity requirement is, for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55582.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">example, changed to 2500 we would approximately get ten or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55608.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">less of the diagnostic window phase.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:55634.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:55661.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Infectivity of low titer HCV RNA transfusion has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55688.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">already been mentioned by Michael Busch.  There are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55714.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">different applications compared to ours, and Schutler was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55741.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">also recognized before.  There are some examples which at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55767.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">least could be the basis for the concern that blip</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55793.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donations or low titer donations are, indeed, infectious.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:55820.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:55847.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Summarizing this study, our conclusions are that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55873.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the HCV core assay protects, indeed, the majority of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55899.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">window phase donations but not all, and for a country which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55925.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">already has NAT regulations in place with a higher</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55952.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sensitivity, it is not easy to substitute HCV NAT by such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:55979.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">an assay.  So, the sensitivity of the core assay is lower</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56005.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">compared to our regulation at the moment.  We know that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56031.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">there is a second version of the core antigen assay</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56058.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">available which is much more sensitive and the question, of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56084.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">course, reappears.  For low titer viremic samples, like the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56111.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">blip samples, RNA concentration on a single donation NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56138.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">would detect these samples.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:56232.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:56268.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:56944.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:56955.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:56965.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:56976.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:56294.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:56321.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I come to the second topic, HIV-NAT.  We had the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56348.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">recent experience in the last three years of transmission</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56374.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of HIV to recipients of blood transfusions in four</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56400.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">documented cases.  So, window phase donations were the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56426.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">cause for transmission of the virus, and we analyzed these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56453.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">cases retrospectively and three of them were p24 antigen</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56480.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">negative.  One was p24 antigen positive.  But all of these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56506.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donations had virus titers which would be easily detected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56533.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">by even minipool or pooled NAT.  Three other donations have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56559.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">already been identified during this period by NAT, which is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56585.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">applied on a voluntary basis already by many of the blood</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56612.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donation centers in Germany.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:56639.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:56665.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The further background concerning HIV-NAT in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56691.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Germany, the plasma industry already requires plasma tests</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56717.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for HIV RNA.  Therefore, at least the major blood donations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56744.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have already introduced HIV RNA testing.  So, 75 percent of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56771.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the donations are already covered.  The reason for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56797.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transmissions would have been prevented by HIV-NAT on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56823.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">minipools.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:56850.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:56876.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">As a consequence of this, we are discussing now</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56903.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">introduction of HIV NAT for the next year.  This should</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:56930.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">cover the cellular blood components as well plasma.  The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:57024.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:57060.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:57736.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:57747.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:57757.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:57768.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57086.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">proposed sensitivity in this case is 10,000 international</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57113.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">units per milliliter which corresponds approximately to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57140.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">5000 copies per milliliter.  This should come in place</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57166.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">during the next year.  Again, we will accept validated in-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57192.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">house methods or commercial NAT methods which have been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57218.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">approved by EPI.  In the time being we are performing a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57245.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">collaborative study on in-house NAT assays, which will be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57272.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">finished in December of this year, or during this month.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57298.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We have now 19 different in-house assays, similar in-house</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57325.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">assays which participate in this study which are performed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57351.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in blood donation centers and for HCV, 22.  So, there is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57377.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">quite a high range of those assays already performed.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:57404.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:57431.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Again, the RNA titers are increased during the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57457.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">window phase of HIV.  We see that if we would rely on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57483.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">p24 antigen assay only at the high titer, RNA donations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57509.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">would be detected by p24, and by this proposed sensitivity</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57536.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">requirement we would close the window by approximately</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57563.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">three to four days compared to the situation if we would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57589.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">introduce p24.  So, this is the current situation.  There</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57615.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is some delay.  The RNA doubling time for HIV is 21 hours</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57642.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and one can calculate the effect of increasing sensitivity</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57668.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">on this basis.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:57695.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:57816.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:57852.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:58528.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:58539.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:58549.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:58560.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:57878.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">There are many discussions in Germany concerning</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57905.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">royalties for screening markers of NAT and these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57932.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">discussions also are the basis for certain delays in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57958.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">introduction of NATs in different countries.  First of all,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:57984.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the royalties are to be paid for single donation.  This is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58010.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in principle also supported by EPI because with this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58037.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">requirement we can get rid of the bigger pool sizes because</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58064.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">it is not much more cost effective compared to single</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58090.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donation or small pool sizes.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:58117.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">On the other hand, in our estimation the size of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58143.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the royalties is difficult to justify.  Nobody has any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58169.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">questions about royalties in principle but if you compare</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58196.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the size of the royalties to the royalties which have to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58223.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">paid for anti-HCV assays, there is a lot of benefit</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58249.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">compared to the introduction of HCV NAT and there are not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58275.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">very good arguments, at least if this is compared.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:58301.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Furthermore, there are some feelings in Europe</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58328.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that NAT manufacturers didn't contribute too much to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58355.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">introduction of HCV NAT and the major work was done by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58381.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">blood donation centers and plasma manufacturers in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58407.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">past, and now that the feasibility has been shown these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58434.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">manufacturers jumped on and tried to get what they can get.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:58460.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Also, I have to say that from a regulatory point</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58487.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of view royalties which are not expectable or at least the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58514.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sizes are not clearly expectable provide less room for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:58608.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:58644.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:59320.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:59331.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:59341.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:59352.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58670.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">future regulatory decisions because we also have to keep in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58697.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">mind cost and benefit.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:58724.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:58750.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The current situation in Europe, and this is not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58776.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the EU only, is that HCV NAT has been introduced in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58802.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">different countries like France, Germany,  Switzerland,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58829.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Austria, United Kingdom, Norway and Finland but in many of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58856.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">these countries only on a study basis.  So, it is not a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58882.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">permanent regulatory requirement.  Several countries also</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58909.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">allow HCV NAT or HCV antigen testing, like in Italy or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58935.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Spain and in Poland, for example, only HCV antigen is used</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58961.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for screening of blood donations.  So, there is quite a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:58988.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">diffuse picture around Europe, and this picture will</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59015.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">probably change also based on the outcome of these royalty</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59041.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">discussions.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:59067.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Concerning HIV NAT, this has already been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59093.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">introduced in France, Austria and The Netherlands in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59120.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">past and, as I already said, in Germany we expect an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59147.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">introduction during the next year.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:59173.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:59199.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I come now to viral safety of plasma-derived</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59226.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">medicinal products, and this is the presentation which I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59252.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">currently got from Glenda Silvester, from the European</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59279.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Medicines Evaluation Agency, in London, which is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59306.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">responsible for respective regulations.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:59400.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:59436.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:60112.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:60123.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:60133.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:60144.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:59462.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:59489.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The current situation for plasma-derived</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59516.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">medicinal products is effective treatment and prophylaxis,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59542.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">prophylaxis of conditions causing morbidity and mortality</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59568.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">possible with these products.  The viral safety has been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59594.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">achieved at a high level for blood-borne viruses, HIV, HCV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59621.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and HBV, and for other safety problems they have been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59648.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">minimized.  For example, formation of inhibitors which has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59674.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">been a topic two years ago approximately.  There is also a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59701.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sufficient supply of these products so, in total, there is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59727.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">a favorable benefit to risk balance.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:59753.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:59780.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">You know all the different points with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59807.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">current level of safety of plasma-derived medicinal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59833.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">products has been achieved.  It starts with donor</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59859.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">selection, with testing of donations and, therefore, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59885.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">different viruses, testing for HCV RNA and inactivation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59912.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">procedures, GMP and also antibodies present for some of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59939.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">viruses which have a certain impact on safety.  So, in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59965.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">total we can conclude inactivation and removal procedures,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:59991.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">together with GMP, provide better protection for unknown</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60018.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and new viruses as well and, once identified, testing can</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60044.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">target the specific viruses and minimize the load on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60071.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">manufacturing process.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:60098.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:60192.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:60228.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:60904.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:60915.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:60925.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:60936.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:60254.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This specific testing has already been introduced</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60281.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for HCV.  The requirement for pool testing for HCV RNA is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60308.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">now in place since July, '99.  And, pools must have to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60334.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">non-reactive and a run control of 100 international units</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60360.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">must be detected in a parallel test.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:60386.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:60413.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This has also found place in the European</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60440.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">monograph for human plasma for fractionation.  So,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60466.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">validation of assays is mentioned there.  The internal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60493.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">control to test for inhibitors is prescribed there as the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60519.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">representing state-of-the-art, and guidelines on validation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60545.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of NAT have been defined.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:60572.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:60599.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I would just like to share with you our</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60625.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">experience with this regulation at EPI.  We still use the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60651.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Amplicor HCV in a validated version for retesting also</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60677.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">plasma pools which have been pretested by the manufacturer</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60704.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and are now, by definition, negative for HCV RNA.  In the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60731.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">meantime, since this regulation was in place we have tested</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60757.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">more than 5000 pools and in this big size of pools there</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60783.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">was no repeatedly HCV NAT positive pool identified.  I am</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60810.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sure others who have performed similar retesting have a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60836.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">similar experience.  So, this requirement is now the basis</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:60863.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for, let's say, many discrepant results.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:60890.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:60984.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:61020.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:61696.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:61707.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:61717.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:61728.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:61046.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Last September, September of last year the EMEA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61073.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">workshop on viral safety of plasma-derived medicinal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61100.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">products was held with a particular focus on non-envelope</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61126.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">viruses.  I would just like to share with you the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61152.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">conclusions of this workshop.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:61178.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:61205.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">First of all, it was again stated that there is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61232.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">an excellent safety for envelope viruses and no need has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61258.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">been seen for a regulatory approach for HIV or HBV NAT to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61285.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">be introduced for plasma testing.  Development of improved</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61311.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">inactivation and removal steps for a number of envelope</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61337.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">viruses, on the other hand, remains an objective for all</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61364.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">plasma-derived medicinal products and effective steps need</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61391.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to be implemented for all coagulation factors.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:61417.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Concerning hepatitis A virus, this was also</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61443.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">discussed at this workshop.  The conclusion was that NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61469.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">testing of plasma pools should not be introduced for HAV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61496.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">RNA because of low titer to be expected in plasma pools and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61523.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">because of the experience that screening or testing of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61549.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">plasma pools for hepatitis A virus RNA did not prevent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61575.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transmission of this virus by Factor VIII preparation in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61602.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the past.  This was approximately two years ago.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:61628.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:61776.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:61812.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:62488.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:62499.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:62509.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:62520.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:61838.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">A further topic was parvovirus B19, and there are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61865.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">two aspects of parvovirus B19 transmission itself and also</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61892.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">vulnerability to unknown envelope viruses.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:61918.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:61944.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">First of all, consequences of parvovirus B19</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61970.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">transmission are normally harmless.  It is a common</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:61997.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">infection and we very seldom see problems associated with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62024.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">it, but there are certain risk groups where problems can</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62050.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">occur and these are patients with hemolytic disorders,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62077.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">immunocompromised patients and also pregnant women where</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62103.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the fetus can be infected and cause harm.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:62129.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:62156.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Concerning safety approaches for parvovirus B19,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62183.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">heat treatment of lyophilized products has been shown not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62209.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to be very effective for this virus.  The same is true for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62235.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">nanofiltration.  This has some effect but not a very</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62261.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">efficient effect and new techniques are still in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62288.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">development to inactivate or remove parvovirus B19.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:62315.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">On the other hand, we have neutralizing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62341.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antibodies in immunoglobulins and S/D plasma, nevertheless,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62367.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">high titer parvoviruses may not be neutralized any longer</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62394.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">by the presence of these antibodies as a certain incidence</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62420.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">has shown.  NAT for parvovirus B19 may reduce the virus</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62447.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">load during the process and complement other safety</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62474.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">measures.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:62568.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:62604.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:63280.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:63291.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:63301.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:63312.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:62630.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:62657.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The conclusions on parvovirus were inactivation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62684.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and removal is currently different.  Some approach can give</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62710.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">limited inactivation or removal depending on product and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62736.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">process, and NAT testing of minipools can be estimated as a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62762.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">complementary measure for inactivation and removal, but the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62789.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">impact of this measure has to be proven with respect to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62816.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">virus safety.  There is no final proof, at least up till</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62842.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">now.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:62869.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:62895.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The introduction of inactivation or removal steps</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62921.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">such as NAT -- there are complementary measures such as NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62948.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">should be prioritized for coagulation factors and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:62975.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">solvent/detergent-treated plasma because of reports of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63001.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">proven transmissions by these products, and for NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63027.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">immunoglobulin because of use in high risk patient groups</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63053.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and pregnant women.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:63080.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:63107.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">There is already a draft now out for discussion</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63133.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in the Pharmaeuropa which proposes that the production of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63159.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NAT immunoglobulin, that plasma pools should be tested for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63186.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">parvovirus and the maximum limit has been proposed for 10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:537.00pt;top:63184.40pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63212.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">international units per milliliter of or RNA in plasma</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63239.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">pools.  So, any concentration lower than this is accepted</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63266.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">but higher concentration should be avoided.  This is still</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:63360.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:63396.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:64072.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:64083.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:64093.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:64104.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63422.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">out for comments but this is the first approach in Europe</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63449.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">concerning parvovirus B19.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:63476.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:63502.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Finally, I would like to thank Glenda Sylvester</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63528.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for these slides and you for your attention.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:63554.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. EPSTEIN:  Thanks to you, Dr. Nubling.  If</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63581.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">there are one or two pointed questions for Dr. Nubling?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63608.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Dr. Tabor?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:63634.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. TABOR:  Yes, I want to ask a couple of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63661.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">questions about the HCV core antigen information, and I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63687.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">apologize if I misunderstood what you said.  Are there</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63713.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">countries in Europe where it is being used in place of NAT,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63740.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">or is it being used in addition, or do the individual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63767.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">centers have a choice as to which to use?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:63793.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. NUBLING:  In Spain and Italy it is up to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63819.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">blood donation centers to use NAT or core antigen.  So,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63845.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">they can use either of these.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:63872.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. TABOR:  And this is for blood?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:63899.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. NUBLING:  This is for blood components, not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63925.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for plasma.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:63951.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. TABOR:  And is the technology that is used</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:63978.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">all the same or are there several different manufacturers?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:64004.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. NUBLING:  To my knowledge, there is only one</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64031.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">manufacturer.  It is Ortho which is present at least on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64058.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">European market, and this test is also used in these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:64152.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:64188.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:64864.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:64875.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:64885.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:64896.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64214.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">countries.  Poland is the one country which introduced for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64241.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the time being, on a study basis, HCV core antigen only;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64268.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">not NAT because of the high costs.  But it is not clear at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64294.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the moment if they will continue with this or if they will</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64320.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">change the current requirement.  But for the time being</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64346.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">they have identified quite a huge number of antigen-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64373.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">positive donations which would not have been detected.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:64400.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. TABOR:  One last question, is there a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64426.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reference standard for the core antigen test in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64453.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">European Union?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:64479.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. NUBLING:  No.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:64505.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. TABOR:  Thank you.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:64532.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. EPSTEIN:  Dr. Bianco?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:64559.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. BIANCO:  Celso Bianco.  I was a little bit</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64585.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">confused about your discussion on B19.  On one side, you</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64611.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">said there is a lack of well-defined description of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64637.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">benefits that would come from screening for B19.  On the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64664.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">other hand, you mentioned a guideline that comes from the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64691.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">EMEA that would regulate that screening.  So, you predict</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64717.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that this would be a mandated assay for plasma derivatives</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64743.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in Europe?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:64770.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. NUBLING:  If this is followed it will be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64796.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">mandatory for NAT immunoglobulin only for the time being</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64823.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">because this is defined for a risk group for parvovirus B</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:64850.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">infection and, therefore, this is at least the first</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:64944.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:64980.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:65656.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:65667.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:65677.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:65688.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65006.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">regulation which will be in place probably in the near</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65033.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">future.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:65060.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. EPSTEIN:  Dr. Allain?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:65086.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. ALLAIN:  I still have some trouble with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65112.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">difference, massive difference, eight times difference in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65138.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HCV RNA positive between the Red Cross and the non-Red</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65165.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Cross centers, and I wanted to make sure of several</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65192.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">elements. First, the pool size is the same?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:65218.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. NUBLING:  No.  In Germany we rely on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65245.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sensitivity requirement, 5000 international units have to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65271.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">be detected and there are different approaches to detect</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65297.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this.  So if you have a high sensitive assay, the pool size</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65324.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">may be higher or bigger compared to an assay which has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65351.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">lower sensitivity.  So, it is sure that the 5000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65377.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">international units is fulfilled for all places, for the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65403.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">German Red Cross and for the other blood conation centers.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:65429.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. ALLAIN:  Second, I understand that at least a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65456.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">couple of years ago maybe until now some centers use ultra</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65483.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">centrifugation prior to testing.  Is that still in place</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65509.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">particularly with the Red Cross or only the other centers?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65535.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Or, what is the status of that?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:65562.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. NUBLING:  It is still in place for at least</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65588.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">one big Red Cross center, as far as I know and, of course,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65615.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this centrifugation also has to be controlled by a run</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:65736.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:65772.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:66448.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:66459.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:66469.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:66480.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65798.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">control which reflects the 5000 international units.  It is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65825.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">still in place.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:65852.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. ALLAIN:  Finally, is there any difference in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65878.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the percentage of first-time donors between the two</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65904.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">populations?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:65930.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. NUBLING:  It is a question I cannot answer</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:65957.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">immediately.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:65984.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. ALLAIN:  Because the difference of eight</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66010.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">times is just about what you would expect between first-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66037.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">time and repeat donors.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:66063.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. NUBLING:  Okay, but, of course, the number of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66089.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the smaller centers are not only first-time donors.  But I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66116.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">cannot say what the percentage of first-time donors is in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66143.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the two different settings.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:66169.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. EPSTEIN:  Thank you.  We have a few more</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66195.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">minutes for just general discussion.  I assume that any of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66221.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the earlier speakers will be pleased to respond if there</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66248.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">are questions to be raised.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:335.30pt;top:66248.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Perhaps I will start off with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66275.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">a question for Dr. Alter.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:66301.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">You made a point that hepatitis G has not been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66327.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">found in the liver.  But then you showed us that it readily</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66354.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">affects PBMCs.  So, I think one question we might ask</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66380.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">ourselves is whether we should be looking for an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66407.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">immunological disease if there is a disease to be found.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:66528.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:66564.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:67240.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:67251.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:67261.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:67272.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:66590.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. ALTER:  I think one has to decide whether to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66617.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">make the effort to look for these infections as a group in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66644.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">all kinds of diseases, and certainly diseases where</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66670.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">lymphocytes or cells involved would be a good starting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66696.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">point.  The data on the mononuclear cells came from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66722.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">infectious clone that Dr. Stapleton has developed.  I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66749.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">didn't realize that was available until his paper came out.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:66776.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. EPSTEIN:  Thank you.  Could I ask anyone who</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66802.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">speaks up to please use the microphone and please identify</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66829.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">yourself for the sake of the transcription?  Any other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66855.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">comments or questions?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:66881.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[No response]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:66908.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Well, we will take advantage of a little extra</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66935.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">time.  Let me ask you to be back at 10:55 so that we can</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:66961.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">stay on time.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:66987.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Brief recess]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:67013.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. YU:  Let me introduce the first speaker, Dr.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67040.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">John Saldanha.  He really doesn't need to be introduced for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67067.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this audience.  He is going to talk about the NIBSC/WHO</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67093.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">program.  Let's welcome Dr. John Saldanha.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:204.75pt;top:67118.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">II.  Standardization/Quality Assurance</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:280.50pt;top:67145.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NIBSC/WHO Program</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:67172.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. SALDANHA:  Thank you.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:67199.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:67320.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:67356.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:68032.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:68043.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:68053.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:68064.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:67382.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I would like to thank the organizers for inviting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67409.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">me to this meeting.  What I hope to do in the next 20</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67436.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">minutes is to go through very briefly on the ways that we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67462.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">established the WHO standards for NAT testing and the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67488.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">working reagents.  Then, at the end I would like to talk</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67514.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">about some quality assurance programs that we run.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:67541.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:67568.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I will start off with some definitions.  NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67594.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">assays -- what are we trying to do with NAT assays?  We are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67621.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">trying to measure the amount of nucleic acid in a sample.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67647.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">And, in the past, before we had standardization, these were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67673.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">measured in a variety of units, either genome equivalents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67700.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">or copy numbers or not detectable units.  A program of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67727.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standardization was started in order to assure the quality</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67753.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of data coming out of testing laboratories.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:67779.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In order to be able to standardize assays, we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67805.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">need to provide standards or working reagents and these are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67832.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reference materials which are used in assays to look at the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67859.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">genome equivalents, in this case the variable being</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67885.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">measured.  To be able to do this, we established WHO's</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67911.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">international standards.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:67938.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:67964.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The different systems that we know for measuring</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:67991.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">nucleic acids in samples -- we have got RT-PCR systems, TMA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68018.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and B-DNA assays.  These are used in some form or another,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:68112.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:68148.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:68824.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:68835.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:68845.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:68856.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68174.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">either as qualitative or quantitative assays.  If you use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68201.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">any of these assays, I can guarantee you would get</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68228.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">different answers for the amount of viral RNA or nucleic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68254.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">acid in the system.  This is because nucleic acids are not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68280.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">equivalent in all sorts of preparations.  You have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68306.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">incomplete genomes; secondary structures which might affect</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68333.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the quantitation, etc., etc.  I think it is very difficult,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68360.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">using these systems, to be able to compare results.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:68386.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:68413.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">With the WHO standards we use a common unitage</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68439.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">which is the international unit, and this is an arbitrary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68465.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">unit.  This is to get away from nucleic acid molecules or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68492.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to use the SI systems which is nanomoles per liter which,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68519.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in my opinion, are very difficult to accurately determine.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68545.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">It is, I think, virtually impossible to work out accurately</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68571.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the number of genome equivalence.  So, to get around this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68597.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">problem we defined an arbitrary unit which is the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68624.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">international unit.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:68651.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:68677.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">International standards are used as a gold</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68703.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standard.  These are standards that are established by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68730.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">WHO.  In turn, they are used to calibrate secondary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68756.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standards and then working reagents or run controls which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68783.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">are used to control each assay run.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:68904.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:68940.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:69616.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:69627.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:69637.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:69648.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:68966.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">There are several requirements for a WHO</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:68993.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">international standard.  They should ideally be a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69020.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">lyophilized preparation so that they have long-term</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69046.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">stability, and we do assays to prove this which I will show</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69072.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">you later on.  We should have adequate supplies of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69098.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reagent to last ideally five to ten years.  And, and this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69125.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is important, we normally do a collaborative study using</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69152.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">laboratories from as many different countries as possible</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69178.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to establish these standards.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:69205.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:69231.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The establishment takes a very sort of set form.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69257.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We identify candidate materials and assess the suitability</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69284.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">such as stability; organize a collaborative study and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69311.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">assign a unitage -- a concentration in terms of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69337.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">international units per milliliter.  We then send a report</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69363.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to the WHO expert committee on biological standardization</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69389.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">which meets once a year, and this committee then</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69416.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">establishes the standard.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:69443.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:69469.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">With the studies that we have done so far, we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69495.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have done several studies.  We have looked at hepatitis C</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69522.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">right through to hepatitis A, and we normally have a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69548.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">variety of candidate materials.  In the first study we had</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69575.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">two materials from NIBSC and a liquid preparation from CLB,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69602.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in Holland.  With HIV, we had a material from CBER which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:69696.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:69732.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:70408.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:70419.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:70429.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:70440.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69758.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">was lyophilized, and with B19, the same thing, and with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69785.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HAV, which is our latest standard, we had materials from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69812.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">ISS, in Italy.  The ones that are colored, the candidate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69838.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">samples, went on to become the eventual WHO standards.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:69864.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:69890.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">These are the standards which we have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69917.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">established.  The first WHO standard for NAT testing was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69944.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">established in 1997 for hepatitis C virus RNA.  This was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69970.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">followed by two standards established in 1999 for HIV-1 RNA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:69997.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and hepatitis B DNA.  The parvovirus standard was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70023.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">established last year, and we are completing the study on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70049.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the hepatitis A standard.  So, these are the four major</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70076.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">blood-borne viruses which have WHO standards established.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:70103.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:70129.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">What do these standards consist of?  These</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70155.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standards are wild type viruses diluted in plasma or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70181.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">cryosupernatant.  The hepatitis C is genotype 1A and has 5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70208.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">times 10 international units per vile.  The B is a genotype</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:183.75pt;top:70206.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70235.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">A, surface antigen subtype ADW2.  The HIV-1, which is the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70261.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">material from CBER, is genotype B material, and these have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70287.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">all been assigned concentrations in international units per</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70314.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">milliliter.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:70340.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:70367.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We choose the concentration in international</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70394.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">units per milliliter to be as close to the determined value</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:70488.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:70524.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:71200.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:71211.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:71221.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:71232.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70550.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in NAT units per milliliter.  This is to save a bit of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70577.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">confusion.  Of course, the quantitation, as I mentioned</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70604.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">earlier, will differ with different viruses.  So, the ratio</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70630.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of international units to NAT detectable units per</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70656.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">milliliter will also differ for each virus.  What I think I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70682.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">am trying to get away from is to encourage people to use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70709.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">international units and not try to convert NAT detectable</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70736.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">units into international units because this ratio is very</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70762.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">dependent on the type of assay that is used.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:70789.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:70815.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Having said that, I can give you some figures and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70841.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">you can see, for example, that for hepatitis C virus the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70868.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">ratio differs between 3.3 to 8.3.  This is basically</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70895.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">because the assays differ in their sensitivity.  With</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70921.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">hepatitis B it is about 2.0 to 7.0  With HIV it is about</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70947.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">0.7 and B19 is about 0.628.  Ideally, we should have a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:70973.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">ratio of 1.0 to 1.0.  This doesn't work out.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:71000.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:71027.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The other aspect of the study is stability of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71053.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">international standards.  There are two ways of doing these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71079.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">studies.  We can do real time stability studies and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71106.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">accelerated degradation studies.  In accelerated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71132.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">degradation studies vials of the sample are incubated at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71159.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">different temperatures and then the quantity of virus is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:71280.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:71316.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:71992.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:72003.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:72013.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:72024.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71342.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">measured to look for the degradation.  You can make some</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71369.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">assumptions to account for the stability of the material.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:71396.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:71422.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">There are limitations to the stability studies.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71448.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We real time studies you can get changes in sensitivity of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71474.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the assays over time so that what we are measuring may not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71501.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reflect degradation but reflect the increase in sensitivity</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71528.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of the assay over a period of years.  There is low</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71554.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">individual assay precision and the time scale is probably</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71581.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">longer than the shelf life of the sample.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:71607.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Accelerated degradation studies also have their</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71633.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">problems.  At high temperatures of storage, where you get</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71660.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reliable data for working out the degradation, you can</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71687.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">often get difficulties in reconstitution of the material,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71713.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and reliable estimates are difficult to work out.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:71739.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:71765.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">If we look at the hepatitis C international</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71792.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standard, we did some accelerated degradation studies on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71819.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this and showed that there was no loss of titer for samples</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71845.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">stored at 20 degrees for about 200 days.  Working through</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71871.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">some calculations, which I won't go through, this equates</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71898.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to stability of the material for over two years at zero</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71924.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">degrees and below, and we store all international standards</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:71951.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">at minus 20 degrees.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:71978.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:72072.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:72108.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:72784.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:72795.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:72805.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:72816.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:72134.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I also have real-time data on the international</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72161.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standard and this is because we have done three studies, in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72188.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">1997, to establish the international standard, and two</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72214.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">calibration studies for working reagents and genotypes, in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72240.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">1998 and 2000.  I think it is obvious that the titers of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72266.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the sample in not detectable units per milliliter for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72293.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">qualitative assays really hasn't changed very time over</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72320.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">four years, and the same for the assays, which are the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72346.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">quantitative assays given genome equivalents per</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72373.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">milliliter, are around 5.8.  So, I think these are real-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72399.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">time data on the stability of the hepatitis C international</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72425.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standard.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:72452.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:72479.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The other thing that we need to consider is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72505.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">replacing the international standard because although the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72531.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standard is supposed to last five to ten years, we have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72557.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">practically run out of the standard already, and this is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72584.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">because of the high usage because of the regulations in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72611.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Europe, and we have very few vials remaining of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72637.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standard.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:72663.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In the original study we had a second material,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72690.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">B, which was also calibrated.  At the SOGAT meeting, which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72716.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is a WHO working group, we decided to replace the existing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72743.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standard with this material, B.  We are going to do that by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72770.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">looking at the stability of the second material against the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:72864.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:72900.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:73576.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:73587.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:73597.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:73608.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72926.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">existing standard in a series of degradation experiments,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72953.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">basically to show that the titer of the second material</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:72980.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">which has been stored at minus 20 is equivalent to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73006.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">first material.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:73032.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:73058.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The other thing that we have done is to calibrate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73085.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">working reagents against the international standard.  In an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73112.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">ideal world we should first establish an international</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73138.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standard and then make secondary reagents from this.  But,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73165.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in fact, with hepatitis C and HIV-1 working reagents were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73191.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">established long before the international standards and it</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73217.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">was necessary to calibrate these working reagents against</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73244.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the international standards.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:73271.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:73297.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">With hepatitis C, we have calibrated four</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73323.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">genotype-1 reagents and one genotype-3 reagents against the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73349.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standard, and that has been published.  With HIV-1, we have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73376.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">calibrated working reagents, 7 type B reagents against the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73403.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">international standard.  The preliminary results are being</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73429.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">completed, and I think the study is about to be published.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73455.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, we have all the commonly used working reagents at the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73482.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">moment which are calibrated in international units per</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73508.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">milliliter, which makes comparison of results and any sort</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73535.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of legislation that is brought in much easier I think.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:73656.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:73692.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:74368.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:74379.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:74389.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:74400.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:73718.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The other study we have done is to calibrate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73745.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">genotypes or subtypes of HCV and HIV against the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73772.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">international standards.  The C international standard is a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73798.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">genotype 1A and the HIV-1 international standard is a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73824.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">genotype B.  There is an argument saying that is it</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73850.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">possible to calibrate genotypes 2 to 6 against the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73877.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">international standard and these subtypes A to H, N and O</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73904.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">against the HIV-1 international standard?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:73930.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We have completed the analysis of this study and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73957.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this study is currently under way.  I will show you some</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:73983.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">results for this study which has been completed in the next</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74009.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">few slides.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:74036.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:74063.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is to illustrate the way that we analyze the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74089.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">results.  We send out panels to laboratories and then work</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74115.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">out the titer of the samples, and have this sort of chart.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74141.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This gives the number of the lab and the titer of the virus</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74168.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">determined by the lab.  These are just the different types</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74195.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of assays, Amplicor, TMA, in-house single loop, in-house</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74221.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">nested.  I think it is obvious that most of them cluster</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74247.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">around.  There are no sort of outliers, which I think is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74274.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">good news.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:74300.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:74448.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:74484.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:75160.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:75171.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:75181.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:75192.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:74510.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">These are examples of the Amplicor assay, which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74537.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is the quantitative Amplicor assay calibrated in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74564.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">international units per milliliter.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:74590.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:74616.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">These are the results of the qualitative assays</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74642.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in not detectable units per milliliter, and the monitor</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74669.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">assays in international units per milliliter.  Again there</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74696.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is very little difference between these figures.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:74722.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:74749.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This, again, is an illustration of the genotype 2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74775.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sample.  Again, most of the laboratories get the same sort</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74801.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of figure.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:74828.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:74855.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In this table I will show you the calibration of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74881.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the genotypes against the international standards.  What we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74907.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have done is we have compared the titers of these materials</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74933.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">against the international standard and got a figure in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74960.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">international units per milliliter.  So, for genotype 2,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:74987.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">which is that figure, it has approximately 10 international</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:450.75pt;top:74984.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75013.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">units per milliliter and genotype 6 has approximately 10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:529.50pt;top:75011.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">4.65</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75039.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">international units per milliliter.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:75066.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:75092.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">There are several conclusions we can draw from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75119.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this study.  The majority of participants in this study</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75146.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">used the Amplicor assay and I am afraid there was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:75240.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:75276.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:75952.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:75963.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:75973.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:75984.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75302.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">insufficient representation of other assay types to allow</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75329.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">full assessment.  So, I guess the overall means are biased</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75356.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">towards the Amplicor assay.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:75382.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:75408.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We now have a panel of genotypes which are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75434.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">available for use.  Although we haven't got an official</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75461.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">calibration yet, we have calibrated them in international</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75488.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">units per milliliter and the data, I hope, will be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75514.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">published fully.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:75541.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:75567.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We have got valuable information on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75593.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">performance of assays across the genotypes and the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75620.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">definitive assessment really needs to be done by using more</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75647.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">assays with the B DNA and TMA.  We have had only one</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75673.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">laboratory doing the B DNA assay and three doing the TMA in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75699.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the study.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:75725.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:75752.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I will briefly go on to quality assurance.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75779.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Quality assurance is defined as plans and systematic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75805.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">activities implemented within a quality system.  Basically,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75831.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in quality we are looking for degree of excellence,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75858.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reliability, fitness of purpose, freedom from effects and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:75884.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">conformance to requirements.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:75911.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:76032.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:76068.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:76744.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:76755.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:76765.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:76776.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:76094.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Within NAT, in a NAT quality assurance program we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76121.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">need to have access to good calibrated international</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76148.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standards and working reagents which can be used in our</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76174.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">assays.  We need to calibrate genotype panels, which we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76200.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have for HCV and HIV-1 for looking at the specificity of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76226.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the assays.  We also need to take part, at least once or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76253.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">twice a year, in proficiency studies to monitor the overall</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76280.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">performance of the laboratory.  So, these are the sort of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76306.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">quality issues that a NAT lab faces, I think, to be able to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76333.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">work well.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:76359.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:76385.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is a list of the NAT working reagents, which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76412.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I am sure most of you have seen before, and these are the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76439.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reagents which were available from NIBSC for hepatitis C,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76465.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HIV-1 and 2.  I give these figures in international units</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76491.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">per milliliter if you divide this by about half.  B19,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76517.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">hepatitis B, hepatitis A, we haven't got an international</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76544.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standard yet, and a multiplex standard which has all five</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76571.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">viruses of these concentrations.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:76597.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">There are also other working reagents, C, HIV-1,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76623.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HBV and B19, available from other laboratories and I think</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76650.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Mei-ying Yu will describe the CBER reagents, and these have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76676.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">all be calibrated again to respective international</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76703.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standards.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:76730.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:76824.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:76860.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:77536.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:77547.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:77557.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:77568.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:76886.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Going on to proficiency studies, these are blind</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76913.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">panels which are tested once or twice a year, and what they</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76940.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">do is look at performance of a validated assay and show the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76966.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reproducibility of the assay, confirm the skill of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:76992.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">laboratory and compare the results of one laboratory to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77018.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">another.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:77045.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:77072.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In the U.K. I run a group called the U.K. NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77098.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">testing laboratories.  We, so far, have sent out three</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77125.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">proficiency panels over the years.  The first two panels</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77151.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have dilutions of genotypes 1 and 3, ranging from 50,000 IU</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77177.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to 0.2 IU.  The third panel had dilutions of genotypes 1 to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77204.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">6 and negative controls.  Over the years the participants</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77231.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have increased from six to nine in these panels.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:77257.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:77283.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">My final slide is really the results of the last</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77309.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">panel, which I hope you can see.  These are the six</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77336.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">genotypes of hepatitis C, ranging from 100 IU down to 5,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77363.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and 120 for the other four, and five diluent samples.  All</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77389.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the labs to start with could pick up 100 IU/ml of all the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77415.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">genotypes and this fulfills the European requirement which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77442.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Micha Nubling mentioned of a validated assay being able to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77468.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">pick up 100 IU/ml.  There was only one lab that picked up</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77495.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">false positive, and the majority of laboratories could go</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77522.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">down to 20 IU/ml of all the genotypes.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:77616.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:77652.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:78328.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:78339.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:78349.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:78360.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:77678.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, in some ways this is a very good illustration</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77705.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of how the laboratories in the U.K. are actually getting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77732.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">closer together in terms of sensitivity and specificity of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77758.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the assays.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:77784.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I will conclude by saying that for the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77810.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standardization and quality assurance of NAT we now have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77837.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">available the standards which are calibrated in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77864.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">international units, which can be used throughout the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77890.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">world, and we have panels such as genotype panels and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77917.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">proficiency panels for looking at the performance of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77943.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">laboratories.  Thank you.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:77969.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. YU:  Thank you, John Saldanha.  Let's have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:77996.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">some short questions and comments.  Later on in this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78023.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">session we are going to have a discussion session.  Please?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:78049.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. BIANCO:  Celso Bianco.  John, you were very</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78075.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">emphatic in trying to encourage the use of international</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78101.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">units.  However, all the regulatory agencies around the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78128.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">world continue to use -- or most of them -- copies or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78155.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">genome equivalence, at least in some of the regulations.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78181.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">How are we going to agree on something like that?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:78207.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. SALDANHA:  Well, actually the majority of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78234.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">regulatory authorities use international units.  CPMP, as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78260.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Micha Nubling pointed out earlier, define HCV in terms of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78287.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">international units per milliliter.  The German regulatory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78314.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">authorities have 5000 IU/ml as well.  In the U.K. we use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:78408.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:78444.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:79120.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:79131.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:79141.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:79152.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78470.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">100 IU/ml.  With HIV the problem is slightly more difficult</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78497.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">because the HIV-1 assays have been well established and it</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78524.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is only recently that we have had an international standard</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78550.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and the calibration studies have only just been completed.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78576.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">But what I hope is that once these materials are available</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78602.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and have been calibrated most laboratories will switch over</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78629.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to IU because it makes things so much easier.  Although</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78656.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">people talk about copies and genome equivalence, as far as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78682.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I can see, they are not strictly equivalent and you can't</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78709.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">compare one with the other.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:78735.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. YU:  I would just like to comment that CBER</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78761.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">now is going to use IU versus copies.  Okay?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:78788.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. BISWAS:  Thank you very much, John.  Our next</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78815.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">speaker is Dr. Micha Nubling, from the Paul Ehrlich</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78841.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Institute, who will talk about the European standardization</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78867.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and quality assurance program.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:319.50pt;top:78893.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Europe</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:78920.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:78947.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. NUBLING:  John already mentioned</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:78973.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standardization through common reference preparations.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:78999.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:79026.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I would like to focus on two related but,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79052.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">nevertheless, similar topics, different topics.  This is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79079.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standardization of NAT tests and I would like to introduce</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79106.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">you to the European IVD directive, which is the regulatory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:79200.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:79236.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:79912.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:79923.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:79933.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:79944.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79262.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">framework for future IVD regulation in all of Europe, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79289.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">especially come to the so-called common technical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79316.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">specifications which have been defined for at least some of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79342.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the NAT assays.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:79368.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The second part of my presentation will also</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79394.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">cover quality assurance in laboratory and here I would like</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79421.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to come to the proficiency testing system as it is now</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79448.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">installed for official medicine products controlled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79474.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">laboratories network, which is organized by EDQM in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79501.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Strasbourg.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:79527.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:79553.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">First coming to the European IVD directive, just</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79580.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">a very short introduction, it is a regulation which defines</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79607.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the conditions of placing IVDs on the European market.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79633.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Once these conditions are fulfilled the IVD can be CE</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79659.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">marked and this allows them free movement of IVDs in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79685.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">common market in all of Europe.  The IVD directive defines</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79712.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">quite generally so-called essential requirements which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79739.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">cover mainly reliability of assays and protection of users</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79765.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and third parties.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:79791.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:79818.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is just a picture to make it a little bit</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79844.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">clearer.  In order for a product to become CE marked, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79871.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">manufacturer has to install so-called process specific</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:79898.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">steps, for example, by showing conformity with certain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:79992.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:80028.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:80704.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:80715.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:80725.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:80736.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80054.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standards, like the ISO 9000 standard and EN 46001.  In</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80081.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">addition to this, product specific requirements have to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80108.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">fulfilled which are later on in so-called European</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80134.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">harmonized written standards and in the essential</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80160.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">requirements in the IV directive and, last but not least,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80186.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">let's say the most important products, the so-called high</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80213.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">risk IVDs, which are laid down in the so-called common</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80240.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">technical specifications, CTS.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:80266.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:80293.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The IV directive is a very new regulation and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80319.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">currently we are just in the middle of the first transition</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80345.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">phase, meaning that CE marking is already possible, CE</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80372.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">marking of IVDs is already possible since June, 2000 but,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80399.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">nevertheless, also national approvals can be applied and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80425.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">are still valid.  Then there comes the second transition</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80451.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">phase.  After the end of 2005 all IVDs in Europe have to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80477.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">CE marked and the national regulations, which are quite</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80504.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">different in different countries in Europe, will be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80531.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">replaced totally by this IVD regulation.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:80557.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:80583.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I mentioned already the common technical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80610.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">specifications.  These are product specific requirements,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80636.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and the question is why they have been defined.  With think</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80663.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">they are a flexible, fast and updatable process and this is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80690.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">important for several reasons.  Flexible and fast and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:80784.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:80820.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:81496.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:81507.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:81517.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:81528.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80846.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">updatable because there is a working group, which is a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80873.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">steady working group, which has defined now the first</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80900.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">version of the CTS but if there is a need, they can convene</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80926.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">again and improve or update the current version of the CTS.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80952.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This may be possible if, for example, test improvement</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:80978.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">occur and there is a need for a new requirement.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81005.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Epidemiological changes have occurred in the past and the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81032.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">respective requirements need to have all these changes.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81058.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Also, availability of samples, sample use and diagnostic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81085.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">evaluations change.  For example, yesterday evening we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81111.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">discussed HIV-2 seroconversion panels which are not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81137.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">available at the moment but, for example, once these panels</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81164.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">will be available they would be included in the CTS.  Last,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81191.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">not least, state-of-the-art of IVDs changes quite rapidly</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81217.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">with time and this also has to be reflected by a fast</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81243.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">process.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:81269.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:81296.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The CTS consists of general principles and of a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81323.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">number of qualifications of standards to be used for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81349.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">diagnostic evaluations.  I just want to briefly introduce</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81375.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">some of the general principles which lead, to a certain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81402.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">extent, also to standardization of NAT assays which are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81428.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">concepted for the European market in the future.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:81455.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">One example is that the detection limit of assays</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81482.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">has to be expressed as a 95 percent positive cut-off value</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:81576.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:81612.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:82288.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:82299.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:82309.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:82320.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81638.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">based on the international standard, as John already</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81665.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">introduced and as he made reference to the EPI validation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81692.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">guideline and how this value for the different assays</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81718.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">should be established.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:81744.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Genome and subtype detection efficiency has to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81770.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">investigated and the respective information has to be given</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81797.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to the user.  Quantification limits should also be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81824.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">expressed by reference to the national standards, and that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81850.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is also an approach for how the system failure rate should</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81877.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">be calculated.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:81903.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:81929.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">An important statement in the common technical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81956.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">specifications for NAT assays is that the so-called</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:81983.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">functionality control or internal control is a check for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82009.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the whole procedure, including extraction/amplification</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82035.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">detection estimated as the current state-of-the-art.  So,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82061.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">any test without such a control will have problems in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82088.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Europe.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:82115.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:82141.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">There are also certain statements made about how</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82167.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to investigate robustness, including pre-seroconversion</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82194.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">samples, high titer samples.  Carryover has to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82220.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">investigated and also the whole system failure rate has to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82247.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">be established.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:82274.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:82368.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:82404.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:83080.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:83091.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:83101.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:83112.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:82430.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The number and qualification of samples have been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82457.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">defined for the tests which could be used, at least for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82484.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">blood banks.  So, certain numbers of subtypes and genome</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82510.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">types have been defined, and also how these numbers could</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82536.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">be achieved.  I already mentioned the detection limit.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82562.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is just to give you an impression.  There are many</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82589.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">other tables.  Also, for specificity certain numbers have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82616.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">been agreed to for the different NATs for different</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82642.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">viruses, how specificity should be expressed.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:82669.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:82695.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">At the moment, we still have national approvals</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82721.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and different manufacturers contacted PEI also in order to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82748.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">get approval.  At the moment we have some problems or at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82775.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">least discussions with tests, why the whole procedure is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82801.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">controlled.  An NAT procedure may start with a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82827.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">concentration of viruses, for example, by centrifugation,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82853.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">then extraction, precipitation and capture of nucleic acid</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82880.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">amplification and detection of amplification products.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82907.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Assays which have internal controls or positive controls</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82933.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">which consist of </FONT></FONT><FONT COLOR="000000"><u><FONT STYLE="font-size: 12.00pt">in vitro </FONT></u><FONT STYLE="font-size: 12.00pt">transcripts cover only these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82959.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">later steps of the whole procedure and, for example,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:82986.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">centrifugation and detection of viral genomes is, by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83012.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">definition, not controlled.  For the time being, therefore,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83039.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">at least it is discussed at the moment if a parallel run</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83066.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">control should be required for such tests, which contains</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:83160.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:83196.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:83872.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:83883.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:83893.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:83904.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83222.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">real virus and which should be performed once per run in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83249.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">order to control at least once per run the whole process.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83276.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Of course, this run control should contain the targets in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83302.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">suitable concentrations in order to make sense.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:83328.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So far the so-called common technical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83354.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">specifications are still in a draft version at the moment,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83381.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">but they will be accepted by the European Commission in due</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83408.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">course very probably.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:83434.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:83461.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The second topic of quality assurance and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83487.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">official medicine control laboratories, or MCLs, as already</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83513.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">mentioned several times, there is a requirement for pool</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83540.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">testing for HCV RNA and pools have to be non-reactive and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83567.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">run controls have to be used and methods have to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83593.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">validated by internal controls to test for inhibitors.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83619.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is the requirement as it is stated in Europe, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83645.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">there is also testing of plasma derivatives, the so-called</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83672.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">OMCLs have to retest the manufacturing pools, and a future</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83699.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">target is that there could also be a mutual recognition</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83725.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">between OMCLs in the future.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:83751.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:83778.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So OMCL retests these manufacturing pools and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83804.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">there were efforts made by the European department for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83831.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">quality of medicines, in Strasbourg, to implement and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:83858.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">maintain excellence among the different OMCLs in order to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:83952.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:83988.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:84664.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:84675.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:84685.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:84696.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84014.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">allow potentially in the future mutual recognition.  This</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84041.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">consists of exchange of expertise and experience between</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84068.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">different OMCLs between, let's say, more experienced OMCLs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84094.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and OMCLs which just start with NAT testing.  In this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84120.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">network, also a validation guideline has been defined and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84146.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">testing modalities -- how many samples should be tested;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84173.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the algorithm for getting final results -- have been agreed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84200.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">upon.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:84226.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Also, EDQM also defined or prepared the so-called</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84253.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">biologic reference preparation which is estimated as a kind</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84279.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of European standard for HCV RNA, and last but not least,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84305.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">established a proficiency testing system for the different</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84332.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">OMCLs.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:84359.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:84385.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I would like to summarize shortly what has been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84411.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">obtained in this field so far.  The whole proficiency</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84437.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">testing system started in 1998.  At this time, before the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84464.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">respective regulation came into place, it was a kind of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84491.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">trial phase and OMCLs exchanged materials and performed a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84517.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">kind of self-assessment with common samples.  At this time</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84543.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">there were eight OMCLs through Europe which volunteered.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:84570.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Since 1999, since this regulation has been in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84596.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">place, there has been a certain system established for how</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84623.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this proficiency testing has to be performed.  First of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84650.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">all, there is an external scientific advisor who designs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:84744.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:84780.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:85456.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:85467.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:85477.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:85488.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84806.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the protocols.  Two studies are performed per year.  A set</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84833.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of 20 coded samples is sent out to the different OMCLs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84860.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">containing different dilutions of HCV RNA positive samples</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84886.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and also different genotypes.  The main focus is not to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84912.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">obtain maximal sensitivity but to focus on the consistent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84938.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">detection of the 100 international units, which is the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:84965.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sensitivity limit for this plasma pool requirement.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:84992.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In the meantime, since 1999, six studies have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85018.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">been performed.  The missing study is just being finished</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85045.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">at the moment.  The number of participants increased from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85071.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">eight in the beginning to between 12 and 14, and these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85097.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">OMCLs come from different European countries as well as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85124.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">from Australia.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:85151.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:85177.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I would just like to summarize in very few words</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85203.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the results.  In the first two years this was still a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85229.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">start-up phase for new NAT labs for several of the OMCLs.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85256.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, a first failures had to be recognized in some labs.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85283.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">These 100 international units were not detected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85309.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">consistently, but over the different studies there was a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85335.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">steady overall improvement.  The last study where the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85362.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">results have been obtained there was no failure at all, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85388.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">all the OMCLs which participated had 100 percent detection</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85415.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of this concentration, which is important.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:85442.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:85536.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:85572.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:86248.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:86259.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:86269.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:86280.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:85598.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This are just the results of the last study which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85625.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I just mentioned.  It is not very good to read but here are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85652.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the 100 international units in this sample.  Here are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85678.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">higher concentrations, and they all got positive results.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85704.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">It was 100 percent positive, and with 32 international</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85730.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">units still 86 percent of OMCLs get positive results.  What</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85757.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is at least as important is that for negative samples there</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85784.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">were no false-positive results reported.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:85810.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:85837.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, this was a short overview about the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85863.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">proficiency testing system as it is performed for control</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85889.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">laboratories in Europe, and I have to mention EDQM who</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85916.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">provides the umbrella under which the studies are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85943.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">performed, especially Guy Rautman and Jean Mark Spieser who</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85969.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">put much effort into this.  As I mentioned also, there are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:85995.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">external scientific advisors and two of them are present</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86021.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">here today.  Thanks a lot.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:86048.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. BISWAS:  Thank you very much.  Are there any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86075.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">questions for Dr. Nubling?  Yes?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:86101.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. GALLARDA:  Jim Gallarda.  Dr. Nubling, can</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86127.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">you describe the relationship between the OMCL guidelines</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86154.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for an external run control which specifies 100 IU/ml as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86180.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">compared to the European Pharmacopeia supplement 2000,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86207.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">which says a run control should be some multiple of the 95</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86234.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">percent limit of detection of the technology?  I am just</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:86328.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:86364.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:87040.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:87051.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:87061.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:87072.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86390.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">wondering if one supersedes the other, or if there is some</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86417.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">harmony between the European Pharmacopeia and OMCL.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:86444.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. NUBLING:  From an acoustic point of view, I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86470.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">didn't understand everything, but I think you asked for the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86496.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">95 percent positive cut-off value in relation to the 100</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86522.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">international units?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:86549.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. GALLARDA:  Right, the European Pharmacopeia</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86576.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">supplement 2000 specifies that an external run control for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86602.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NAT should run at some multiple of the 95 percent limit of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86629.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">detection of the assay.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:86655.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. NUBLING:  Yes.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:86681.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. GALLARDA:  Whereas, the OMCL specifies 100</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86708.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">IU/ml for that external run control.  I was wondering about</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86735.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the difference in the two organizations.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:86761.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. NUBLING:  Maybe I do not understand your</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86787.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">question but I will try to answer to the extent that I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86813.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">understood it.  This 95 percent cut-off value defines the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86840.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">concentration, a method to detect in 95 percent of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86867.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">assays.  So, if I would have an assay which would detect</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86893.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">consistently this 100 international units, the 95 percent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86919.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sensitivity of this assay would be approximately 30</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86946.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">international units.  This is a prerequisite because a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86972.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">factor of three gives you a certainty of nearly 100 percent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:86999.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">detection in three times higher concentration.  This is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:87120.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:87156.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:87832.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:87843.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:87853.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:87864.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:87182.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">what we need to achieve in order to take consistently these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:87209.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">100 international units.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:87236.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. BISWAS:  Micha, I have a quick question for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:87262.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">you.  You had mentioned something about a whole system</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:87288.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">failure rate.  What do you mean by that?  What would be a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:87314.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">partial system failure rate?  What does that mean?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:87341.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. NUBLING:  A whole system failure rate is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:87368.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">defined for a complete system which is installed, for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:87394.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">example, by a manufacturer in a laboratory, including</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:87421.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">extraction and everything.  And, one parameter which should</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:87447.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">be investigated is the complete procedure to be, let's say,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:87473.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">challenged by low titer samples in order to get</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:87500.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">independently which step makes the failure to get the whole</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:87527.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">failure rate of the system.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:87553.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. BISWAS:  Thank you very much, Micha.  Our</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:87579.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">next speaker is my colleague, Mei-ying Yu, from CBER, FDA.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:312.75pt;top:87605.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">CBER/FDA</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:87632.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:87659.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. YU:  In my talk I will cover standardization</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:87685.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for donor-screen NAT and in-process control NAT, and also I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:87711.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">will address the other quality assurance issues.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:87738.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:87764.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">As you all know, standardization of NAT methods</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:87791.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is very essential because we have diverse NAT methods, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:87818.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">they have varied sensitivity, specificity and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:87912.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:87948.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:88624.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:88635.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:88645.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:88656.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:87974.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reproducibility.  We also have varied minipool size for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88001.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HIV, HCV NAT.  We have 96 to 1200 for source plasma, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88028.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for whole blood we have from 16 to 24 pool size.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:88054.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We also need analytical standards.  This is so</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88080.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that we can have a standardized assay and also standardized</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88106.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reporting so that we can report it either as copies or,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88133.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">preferably, IU/ml.  Analytical standards will monitor</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88160.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">laboratory proficiency and will be used for lot release of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88186.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">test kits.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:88213.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:88239.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Donor screen NAT, this is in BPAC, Blood Products</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88265.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Advisory Committee, held in March, 1997 and it says the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88292.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">pool test for HIV, HCV and HBV is a form of donor</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88319.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">screening, requiring IND and licensure.  Dr. Paul Mied</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88345.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">already mentioned that this morning.  So, we need a donor</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88371.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">identification notification deferral and follow-up.  We</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88397.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">need to identify and notify recipients of implicated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88424.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">products.  We need to quarantine or destroy the positive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88451.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">units and components, and we need to perform look-back to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88477.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">retrieve, destroy and unpooled or untransfused units.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:88503.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:88530.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We do have CBER NAT standards for donor screened</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88556.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NAT.  There are not standards available for HIV and HCV.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88583.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Currently, the NIS standard for HBV is under development.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88610.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The current required analytical sensitivity is 100 IU/ml</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:88704.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:88740.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:89416.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:89427.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:89437.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:89448.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88766.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for pool tests and 5000 IU/ml for original donation.  Note</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88793.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that this is IU/ml, not copies/ml.  The current guidance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88820.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">document, the CBER guidance document has yet to be updated.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:88846.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:88872.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The CBER HCV panels were formulated from window</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88898.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">period units.  This is negative for anti-HCV, of course,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88925.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and is anti-HIV and HBsAg and not detectable for quite a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88952.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">few other viral agents.  It is HCV genotype 1B.  The entire</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:88978.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HCV sequence is known.  This is in collaboration with Dr.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89005.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Steve Feinstone that we determined the entire sequence.  At</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89031.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that time, five laboratories participated in small-scale</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89057.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">studies, and it was determined to contain 5 times 10 copies</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:501.00pt;top:89055.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89084.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">per milliliter.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:89111.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:89137.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, current CBER HCV RNA panels is a ten-member</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89163.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">panel and was derived from the HCV stock, diluted with a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89189.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">defibrinated pool plasma.  We have eight positive, ranging</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89216.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">from 5 to 10 copies per milliliter.  It contains two</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:213.00pt;top:89214.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89243.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">negatives and each was filled 0.57 ml per vial and stored</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89269.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">at minus 70 degrees Celsius.  At that time it was tested by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89295.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">nine laboratories and seems to be very much in the target</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89322.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">levels that we wanted to have.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:89348.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:89375.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Panel member number one, that contains 1000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89402.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">copies/ml, participated in the collaborative studies.  John</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:89496.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:89532.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:90208.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:90219.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:90229.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:90240.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89558.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Saldanha just mentioned it.  That particular collaborative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89585.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">study a total of five international HCV reference reagents</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89612.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">were calibrated against the international standard.  In</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89638.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that particular collaborative study CBER member number one</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89664.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">was assigned to have 250 IU/ml.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:89690.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:89717.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We also have HIV-1 RNA panels in CBER.  Panel A,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89744.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">subtype B has five members, and this is a window period of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89770.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">plasma units diluted with the antibody negative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89797.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">defibrinated pool plasma.  It has four positives, ranging</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89823.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">from 100 to 2.5 times 10 copies/ml, and it has one negative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:299.25pt;top:89821.40pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89849.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and is 1.1 ml per vial.  Actually, the current WHO standard</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89876.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for HIV is originating from this window period unit.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:89903.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:89929.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We also have panel B that is also subtype B that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89955.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">has ten members.  This is a cultured patient isolate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:89981.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">diluted again with defibrinated plasma.  It has eight</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90008.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">positive, ranging from 10 to 2.5 times 10 copies/ml.  It</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:421.50pt;top:90006.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90035.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">does have 105,000 copies in the panels.  There are two</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90061.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">negatives and the fill size is 1.25 ml/vial.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:90087.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:90114.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The third panel is HIV subtype panel.  This is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90140.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">under development.  It has eight subtype panels, A, C, D,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90167.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">E, F, G, N and O.  Each panel has seven members, except</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90194.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that N has four and O has 18 members.  Right now, currently</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:90288.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:90324.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:91000.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:91011.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:91021.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:91032.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90350.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">it is under pilot-scale studies.  It is being characterized</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90377.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and titered by several NAT manufacturers.  Full-scale</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90404.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">panels will be formulated if data obtained from pilot-scale</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90430.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">panels are as expected.  I would like to mention that all</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90456.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">these HIV panels are formulated in Dr. Hewlett's</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90482.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">laboratory.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:90509.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:90536.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In BPAC, held in September, 1999, they agreed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90562.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that -- this is the exact wording that I put in here on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90589.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">slide -- pending a policy on screening whole blood</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90615.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donations, FDA may not require studies to validate the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90641.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">clinical effectiveness of NAT for B19 DNA under IND for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90668.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">plasma for further manufacturing.  So, this only applies</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90695.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for recovered plasma and source plasma, not for whole</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90721.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">blood.  So parvovirus B19 is an in-process control test.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90747.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, it is unlike HIV, HCV and HBV NAT.  However, in that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90773.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">BPAC it was mentioned that we should quarantine and destroy</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90800.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in-date when possible.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:90827.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:90853.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Parvovirus B19 NAT, we need the validation as an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90879.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">analytical test, and approve it under relevant product</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90906.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">license.  Now, the proposed limit, which we mentioned in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90932.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the FDA NAT workshop in 1999 and also the subsequent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90959.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">workshop held by the NHLBI, we said that the proposed limit</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:90986.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is 10 genome equivalent of B19 DNA per milliliter in all</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:162.00pt;top:90983.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:91080.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:91116.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:91792.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:91803.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:91813.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:91824.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91142.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">manufacturing pools.  At that time we didn't have an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91169.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">international standard.  So, we would like to proposed that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91196.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">as 10 IU of B19 DNA per milliliter in all manufacturing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:162.00pt;top:91193.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91222.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">pools.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:91248.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">As you know, this particular level was set</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91274.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">because of the B19 transmission associated with the SV-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91301.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">treated pooled plasma in the Phase IV study in healthy</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91328.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donors.  In that particular instance, less than 10 genome</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:486.75pt;top:91325.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91354.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">equivalent/ml, none of the lots transmitted to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91381.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">recipients.  So, for such high titer screening, whatever</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91407.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the residual B19, it will be neutralized by the anti-B19</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91433.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">present in all large pools, and then also whatever the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91460.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">residual B19 is will be cleared by the manufacturing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91487.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">procedure.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:91513.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:91539.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, for standardization of B19 NAT from plasma</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91565.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for further manufacturing we proposed that, for instance,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91592.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in preclinical studies, like for specificity studies, we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91619.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">proposed to have 500 healthy donors monitored and also</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91645.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">100,000 donations in the form of minipools.  Then for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91671.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sensitivity we would like to have about 20 known positives,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91698.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and for analytical specificity, like interference or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91724.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">analytical sensitivity and precision, it will be very</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91751.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">similar to the guidance documents for HIV and HCV.  As you</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91778.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">know, this is high titer screening for B19.  So, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:91872.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:91908.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:92584.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:92595.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:92605.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:92616.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91934.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">analytical sensitivity had to be greater, much greater than</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91961.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">100 IU/ml.  And, no clinical studies, and we only would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:91988.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">like to make sure that the manufacturing pool will be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92014.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">within less than 10 IU of the B19 DNA per milliliter so</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:263.25pt;top:92012.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92040.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that the viral load in the starting pool would be very low</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92066.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to begin with.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:92093.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:92120.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is for the B19 DNA standard.  This is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92146.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">derived from a window period plasma unit that has 10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:501.00pt;top:92144.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">12</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92173.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">equivalent/ml, and we dilute it.  This is with cryopooled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92199.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">plasma.  It is not defibrinated plasma.  This one is anti-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92225.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">B19 negative plasma.  So, the formulated standards contain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92252.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:141.00pt;top:92249.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:152.80pt;top:92252.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">IU/ml.  This is 1 ml per vial.  The consensus titer was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92279.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">determined by collaborative studies because the CBER</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92305.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">preparation is a liquid formulation targeted to contain 10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:544.50pt;top:92303.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92331.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">genome equivalents.  It was a candidate preparation for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92357.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">establishing an international standard for B19 DNA.  Of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92384.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">course, AA, which is the freeze-dried preparation, was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92411.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">selected as an international standard but the CBER standard</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92437.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">was determined to contain 10 IU/ml.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:327.75pt;top:92435.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:92463.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:92490.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, we questioned the BPAC in June, 2000 should</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92516.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the FDA recommend that if a plasma pool or minipool is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92543.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">found to be HAV positive the individual HAV NAT positive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:92664.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:92700.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:93376.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:93387.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:93397.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:93408.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92726.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donors should be identified and notified of the test</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92753.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">results.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:92780.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:92806.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The BPAC decision then was that data provided did</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92832.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">not demonstrate risks significant enough to warrant donor</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92858.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">notification and look-back measures.  So, HAV NAT, by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92885.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">default, for plasma for further manufacturing is an in-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92912.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">process test and is not a donor screened test.  That now</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:92938.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">needs to be validated by a clinical trial.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:92965.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:92991.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We have not yet set any standards for HAV NAT.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93017.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">However, based on the viral load, the HAV NAT will be very</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93044.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">similar to HIV and HCV NAT validation.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:93071.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:93097.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, we formulated a CBER HAV RNA standard, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93123.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this is derived from a window period plasma unit that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93149.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">contained 10 copies/ml, and diluted with the cryopooled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:213.00pt;top:93147.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93176.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">plasma.  It is estimated to contain 10 copies/ml.  However,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.75pt;top:93174.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93203.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the consensus level is still being determined by the WHO</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93229.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">collaborative studies because this was one of the candidate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93255.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">preparations to establish the WHO standards for HAV NAT.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93282.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">And, it is 1 ml/vial, stored at minus 70 degrees Celsius.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:93308.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:93335.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Let me talk about quality assurance.  As you</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93362.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">know, for quality assurance we have assay validation that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:93456.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:93492.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:94168.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:94179.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:94189.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:94200.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93518.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">includes the laboratory tests and well as clinical testing,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93545.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">specificity, sensitivity and precision.  Quality assurance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93572.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">also includes quality control testing of components and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93598.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">final test kits, and acceptance criteria specification has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93624.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to be set to ensure lot-by-lot consistency and also Good</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93650.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Manufacturing and Good Laboratory Practices.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:93677.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:93704.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The quality assurance issues we already talked</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93730.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">about.  We really need to standardize the assay using the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93757.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">well characterized panels and reference standards.  We need</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93783.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to ensure the quality control of components and, finally,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93809.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">test kits using, again, well characterized panels and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93836.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reference standards.  Then, we also need to monitor</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93863.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">operator proficiency using proficiency panels and training</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93889.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">programs.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:93915.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:93941.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Other quality assurance issues, for instance, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93968.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sample preparation includes collection, storage and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:93995.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">extraction and, actually, improved transportation as well.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94021.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The manufacturing consistency of primers, probes and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94047.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">enzymes is very crucial.  Performance of controls,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94074.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">calibrators and quantitation standards, specimen and kit</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94100.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">stability, instrument and software validation.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:94127.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Here I mention some controls and quantitation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94154.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standards, like potency of specimen controls, purity,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:94248.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:94284.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:94960.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:94971.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:94981.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:94992.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94310.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">identity and potency of synthetic oligo, internal controls</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94337.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and quantitative standards.  Then, the stability and you</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94364.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">also need to make sure you have the control set at, you</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94390.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">know, low, medium copy numbers and so forth.  Acceptance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94416.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">criteria and specifications need to be set.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:94442.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:94469.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Finally, in the interest of time, I am just going</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94496.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to mention the issues for pool specimens, for instance, for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94522.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the QA issues.  Demonstrate enhanced sensitivity or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94549.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">equivalence of testing pool, the current methods, evaluate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94575.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the matrix effect due to pooling, and validate logging and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94601.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">tracking procedures for the inventory of specimens in a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94628.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">given pool.  You need quality assurance in computing and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94655.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">recording of results.  We also need to validate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94681.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">instruments, these different instruments and software used</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94707.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to monitor pool specimens.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:94733.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:94760.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We have a guidance document.  We have an FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94787.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">guidance document for HIV-1 and 2, and this can apply for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94813.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HCV and other viruses in general.  Then, we also have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94839.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">another guidance document, a draft guidance document that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94866.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Dr. Mied already mentioned, and there is a guidance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94892.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">document that is specific for NAT for HCV.  It is a very</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94919.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">good document.  Dr. Micha Nubling already mentioned it.  I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:94946.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">list some of the analytical procedures.  Some are FDA and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:95040.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:95076.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:95752.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:95763.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:95773.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:95784.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:95102.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">ICH documents to validate some of the NAT test as an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:95129.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">analytical procedure.  This can be a reference document.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:95156.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:95182.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In summary, NAT is currently being implemented in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:95208.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the U.S. as either donor screening or in-process control.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:95234.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">For standardization, CBER currently has reference panels</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:95261.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for HIV and working reagents for B19 and HAV.  So, we need</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:95288.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">quality assurance for NAT-based tests used to screen blood</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:95314.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and plasma donations.  Thank you very much for your</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:95341.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">attention.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:95367.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. BISWAS:  Are there any questions for Mei-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:95393.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">ying?  No?  In that case, we will break for lunch.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:95420.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. YU:  Is there general discussion for Dr.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:95447.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Saldanha, Dr. Nubling and myself?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:95473.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. BISWAS:  They want lunch!</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:95499.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Whereupon, at 12:05 the proceedings were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:95525.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">recessed to reconvene at 1:05 p.m.]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:95832.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:95868.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:96544.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:96555.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:96565.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:96576.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:226.50pt;top:95921.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">A F T E R N O O N</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:363.75pt;top:95921.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><u><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">S E S S I O N</FONT></FONT></u></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:95948.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. YUWEN:  We are going to start the afternoon</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:95974.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">session.  I would like to make a short announcement for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96000.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this afternoon's schedule.  This afternoon we are going to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96026.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have three sessions.  Session number three is going to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96053.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">experience with the minipool NAT for donor screening, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96080.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">we have numerous industry presentations.  After section</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96106.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">three, we will have section four, which is progress towards</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96133.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">single unit NAT.  Then there is going to be experience with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96159.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">minipool NAT screening for HAV/parvovirus B19.  We have a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96185.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">tight schedule and each presenter is allowed to have no</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96212.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">more than ten minutes.  What I would prefer is for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96239.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">everybody to present about eight minutes or so and leave a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96265.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">minute or two for a short discussion.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:96291.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Once our computer starts, I will first introduce</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96317.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Dr. Any Conrad, representing NGI.  I have a clock with me.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96344.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This will force everybody, and the clock is set for eight</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96371.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">minutes so when the clock clicks you know you have no more</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96397.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">than two minutes left.  Thank you.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:183.00pt;top:96422.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">III.  Experience with Minipool NAT for Donor</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:186.75pt;top:96449.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Screening (HIV/HBV/HCV) Plasma for  Further</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:280.50pt;top:96476.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Manufacturing NGI</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:96503.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. CONRAD:  Hold on a moment.  Don't start my</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96530.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">clock yet!  If any fire alarms go off, I get extra time!</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:96624.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:96660.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:97336.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:97347.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:97357.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:97368.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:96686.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:96713.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I am sure many of us have heard this, we are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96740.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">going to do a summary of the HCV, HIV and HBV trials</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96766.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">conducted with many of my associates, partners and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96792.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">collaborators who you will hear from in a moment.  I will</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96818.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">briefly give the results of the HCV and HIV trials that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96845.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">resulted in our approval, and the status of the HBV.  I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96872.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">thought I would do one other thing.  Since everyone else</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96898.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">who comes after me is going to break down their individual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96925.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">things, I thought I would group all of the testing that we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96951.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have done into one massive group and see how those numbers</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:96977.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">compare to the individual companies that you will hear from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97004.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">later.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:97031.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:97057.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">At NGI we use a modified PCR method technology</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97083.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that uses Southern Blot detection.  I am sure many of you</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97109.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have heard this before.  The HIV and HCV tests are now</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97136.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">approved and HBV is being run under an IND.  We use a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97163.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">robotic pooling device, called the T-can.  It makes pools</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97189.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of 512 -- I apologize to all of you who have seen this 2000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97215.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">times, but we will get this clear one last time.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:97242.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:97268.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">That is the T-can.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:97295.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:97416.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:97452.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:98128.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:98139.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:98149.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:98160.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:97478.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The way we make pools is our pools are eight by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97505.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">eight by eight pools, consisting of 512 members.  So, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97532.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">pools have 512.  If you test a pool and the pool is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97558.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">negative, we make the inference then that all of its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97584.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">component members are negative.  If it is positive, all</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97610.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that you need to do is test a row of eight, a column of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97637.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">eight and a layer of eight and --</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:97664.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:97690.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">--</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:220.15pt;top:97690.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">lo and behold, where the row, layer and column</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97717.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">intersect you have the positive sample.  So, essentially</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97743.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">what it does is -- this is an economy measure; it makes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97769.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">things faster, easier and less expensive.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:97796.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:97823.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The sensitivity assays, as determined in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97849.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">analytical sensitivity components of our submissions were,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97875.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for the HBV, we use 2 ml which comes out with a 95 percent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97901.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">detection limit of 4 copies or 1 international unit; for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97928.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the HCV-1 ml assay we have a 95 percent detection cut-off</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97955.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of 20 copies with 5 international units; and the HIV is 1.4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:97981.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and 5.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:98007.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Listening to Mike Busch's talk this morning, I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98034.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">was struck by an interesting point and I will diverge for a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98060.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">minute from my talk, and that is that when we talk about</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98087.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">single unit testing, the other alternative to that would be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98114.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to drive the sensitivity of assays lower and lower and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:98208.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:98244.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:98920.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:98931.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:98941.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:98952.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98270.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">lower.  Theoretically, by increasing the amount of material</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98297.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that we test we can actually get the detection cut-offs to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98324.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">be sub single unit.  We can make them 0.3 IU/ml.  That may,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98350.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in fact, turn out to be a more economic mechanism than</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98376.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">going to single unit donations.  I think you can achieve</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98402.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the same sensitivity.  If we were to take all 512 members</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98429.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of the pool and test the entire pool instead of an aliquot</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98456.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of the pool, theoretically it would be the equivalent of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98482.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">single unit testing, but that would necessitate us getting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98509.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">better and better mechanisms to purify viruses from high</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98535.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">volumes.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:98561.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:98588.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The clinical trials were conducted on 343,729</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98615.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donations from approximately 48,000 randomly selected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98641.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donors.  The samples were also tested for the standard</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98667.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">immunologic tests, but an important distinction needs to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98693.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">made here, that samples from new donors were tested by RT-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98720.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">PCR only after they had passed their serologic testing, but</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98747.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">all donors that were already in the system or not new to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98773.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the system were tested simultaneously with the RT-PCR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98799.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reaction.  So, there will be numbers that I give you that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98826.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have people who were both serologically positive as well as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:98852.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">serologically negative.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:98879.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:99000.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:99036.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:99712.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:99723.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:99733.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:99744.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:99062.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The results for the HCV were 0.031 percent of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99089.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donations, or 105 out of the 342,000 that were found to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99116.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">positive for HCV, and 85 of these donations were EIA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99142.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">negative.  In other words, they were in the window period.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99168.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">But since other serologic tests also occur, like ALT, we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99194.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">took those 85 samples and we looked at how many of them had</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99221.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">normal ALTs.  So, 75 of those units would not have been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99248.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">interdicted had NAT testing not been employed.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:99274.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:99301.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Just some interesting numbers to keep in mind.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99327.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The mean time to seroconversion for the samples we detected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99353.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in the study was 57 days, plus/minus 14.  The range went</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99380.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">from 22 to 120 days.  The average viral load of these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99407.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antibody-negative ALT normal samples was 1.36 times 10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:515.25pt;top:99404.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">7</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99433.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">copies, so very high titer.  Obviously, that supports all</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99459.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the data that showed this rapid and high increase in viral</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99485.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">load, with a low of 7500 and a high of 56 million</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99512.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">copies/ml.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:99539.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">@342[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:99565.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The HIV results show that 18 out of the 342,000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99591.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donations were found positive for HIV.  Ten were both</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99618.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antibody and antigen negative; eight were positive for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99644.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">either p24 or antibody by the time we encountered them in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99671.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the pooling system.  Of the 18 donations, they came from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:99792.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:99828.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:100504.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:100515.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:100525.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:100536.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99854.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">four donors, for a frequency of approximately 1/12,000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99881.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donors.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:99908.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:99934.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">An important component, which is going to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99960.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">discussed I think in further detail later, is that we made</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:99986.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">supplemental comparisons of the HIV pool testing using NAT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100013.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">compared to both Colter and Abbott's p24 antigen kit.  I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100040.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">think, again, the most important message and summary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100066.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">message here is to notice that the antigen positive, PCR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100093.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">negative samples -- there were none, and this led to our</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100119.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">ability to submit in the license the statement that PCR is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100145.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">a substitute for the p24 antigen test, much to the delight</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100172.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of some and chagrin of others.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:100199.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:100225.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The conclusions are that 75 of the donations for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100251.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HCV wouldn't have been intervened.  A total of 8.5 times</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100277.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">10</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:141.00pt;top:100282.40pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">11</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:157.95pt;top:100277.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">copies were interdicted and not placed into plasma</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100304.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">because of NAT testing, and the HCV plasma testing was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100331.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">actually sort of simple and functional to do.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:100357.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:100383.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">For HIV, six HIV units were interdicted that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100410.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">would not have been detected, for a total viral load of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100436.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">about 7.15 times 10 and, again, an important thing is that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:263.25pt;top:100434.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.25pt">8</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100463.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the safety of the units was actually enhanced by using PCR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100490.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and antibody screening versus p24 and antibody screening.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:100584.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:100620.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:101296.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:101307.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:101317.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:101328.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:100646.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:100673.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HBV, just briefly a summary because you are going</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100700.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to see a lot of detail about this, we have actually</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100726.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">identified two different classes of individuals.  We found</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100752.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">people who were heading towards an acute stage of HBV,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100778.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">where they have a rapid escalation in viremia, followed by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100805.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">S-antigen positive, and those people then get brought out</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100832.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and those are the acutes.  We have also found a second and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100858.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">more common class of people whom we call the chronics, who</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100885.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have these sort of low, smoldering viral loads.  They are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100911.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">also sometimes S-antigen positive but we have also found a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100937.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">group in here who have S-antibody, core antibody.  So, they</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100964.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">are S-antigen negative but they still have some DNA.  So,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:100991.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HBV adds a more complicated series of issues that have to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101017.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">be addressed, and I think that you will hear more about</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101043.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that in a bit from my colleagues.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:101069.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:101096.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">But there are four classes of people that you can</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101123.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">encounter, the HBV core antibody negative, positive and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101149.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">different antigen statuses.  I think that that is going to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101175.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">be important.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:101202.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:101228.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Then, for the last slide I thought I would just</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101255.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">give you the summary of the number of donations that we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101282.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have tested and some of the frequency rates.  We have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:101376.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:101412.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:102088.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:102099.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:102109.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:102120.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101438.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">looked at 11 million, 600-something thousand HBVs for a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101465.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">total of 1136 serologically negative.  We have looked at 18</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101492.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">million HCVs for a total of 1653 serologically negative,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101518.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and we have looked at 14 million HIVs and found 101</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101544.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donations that were serologically negative.  And, those are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101570.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the frequencies for the serologically negative in those</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101597.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">three large studies.  So, 1 in 10,000, 1 in 11,000 and 1 in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101624.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">142,000 for HIV.  That is all.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:101650.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. YUWEN:  Any short questions or comments?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101677.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Yes?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:101703.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. ALLAIN:  You mentioned you have 85 HCV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101729.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">positive and you said there were window periods.  Did they</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101756.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">also convert?  How many of them seroconverted?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:101783.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. CONRAD:  We attempted to follow-up on all</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101809.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">patients in the clinical trial, some of the patients that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101835.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">were donors.  But of all the people who came into the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101861.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">clinical trial that made up those 82, all of them</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101888.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">seroconverted.  So, all the patients whom we were able to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101915.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">follow through time seroconverted.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:101941.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. YUWEN:  Our next speaker is Dr. Lorraine</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:101967.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Peddada, representing Alpha Therapeutic Corporation.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:237.00pt;top:101993.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Alpha Therapeutic Corporation</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:102020.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:102047.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. PEDDADA:  Today I am just going to have a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:102074.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">brief overview of what we did with the HIV and HCV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:102168.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:102204.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:102880.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:102891.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:102901.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:102912.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:102230.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">screening program, and give an update on our progress with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:102257.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HBV PCR.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:102284.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:102310.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We heard the history of PCR already today several</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:102336.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">times, but we actually started in 1997, working with NGI as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:102362.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the principal investigator for the HIV and HCV INDs.  In</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:102389.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">1999 we filed an IND for HBV, and in September of 2001 we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:102416.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">received the first license to test source plasma using PCR.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:102442.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:102469.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We have already gone over our three-dimensional</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:102495.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">pooling scheme.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:102521.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:102548.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is the sensitivity of PCR screening source</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:102575.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">plasma at our pool size, which is 512 donations per pool,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:102601.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and it is about 2000 copies/ml for HIV and HBV and 10,000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:102627.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">copies/ml for HCV.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:102653.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:102680.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">During our clinical trial we submitted data on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:102707.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the enrolled subjects for HIV and HCV, and we did a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:102733.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">retrospective analysis of samples that we had in inventory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:102759.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">from positive donors.  With those panels we were able to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:102786.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">calculate a window period reduction of four days for HIV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:102812.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and 57 days for HCV.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:102839.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:102960.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:102996.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:103672.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:103683.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:103693.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:103704.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:103022.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The HBV clinical study was initiated in August of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103049.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">2000, and our basis for enrolling would be that the donor</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103076.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is PCR positive with minipool testing or hepatitis B</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103102.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">surface antigen positive, but not both.  We had 26 PCR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103128.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">positive eligible donors and we enrolled five.  We had nine</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103154.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HBV surface antigen positive donors and we were able to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103181.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">enroll four.  Our plan was to follow the donors six months</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103208.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">or to seroconversion.  We were monitoring the donors weekly</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103234.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">with PCR surface antigen testing, and later we added anti-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103261.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">core, anti-HBE and E antigen because the donors presented a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103287.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">very complex pattern.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:103313.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:103340.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">With the HBV trial we have only enrolled nine</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103367.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">subjects.  So, what we did was to look in our inventory for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103393.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">panels of donors that would qualify.  We found 65 HBsAg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103419.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">positive donors and we analyzed the look-back donations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103445.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">from all of the donors.  From 65 donors we were able to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103472.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">look at 512 donations, and we screened each one undiluted</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103499.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">by PCR, using the NGI UltraQual test, and 315 were positive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103525.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">undiluted.  Then we prepared simulated master pools of 512</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103551.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and tested again.  We were able to detect 142 of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103578.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donations, which gives us a sensitivity of 45 percent.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:103604.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:103631.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is just to give you an idea of how we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103658.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">calculate window period.  What we are trying to do is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:103752.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:103788.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:104464.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:104475.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:104485.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:104496.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103814.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">determine the amount of time it takes for a donor to go</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103841.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">from being HBV DNA positive to surface antigen positive.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:103868.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:103894.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Because we have the panel of donors, the 65</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103920.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donors, all of the samples and the bleed dates, we were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103946.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">able to make these calculations.  So, with a pool size of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:103973.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">512 we were able to analyze samples from 43 donors and we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104000.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">achieved a reduction of 15 days in the window period.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104026.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Because we were not sure how the master pool of 512 we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104053.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">would work, we also analyzed primary pools of 64 and we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104079.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">were able to reduce the window period by 23 days.  And, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104105.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">total window period as measured by NAT in undiluted samples</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104132.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">was 36 days in our hands.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:104159.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:104185.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is just to illustrate that in the plasma</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104211.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">industry we do have a 60-day inventory hold and by closing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104237.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the window by 15 days we are pushing back our inventory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104264.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">hold 15 days.  Then you add onto that the 60-day inventory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104291.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">hold.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:104317.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:104343.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is a summary of our screening to date.  We</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104370.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have been screening HIV and HCV for four years -- four</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104396.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">years for HIV and HCV.  One year, actually, we did not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104423.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">screen using PCR.  So, that is three years for HIV.  The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104450.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">total donations tested is six million for HIV and the total</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:104544.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:104580.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:105256.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:105267.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:105277.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:105288.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104606.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">number of positive donations was 472 and this includes all</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104633.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">positives, not PCR only.  This gives us a frequency of 8</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104660.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donations per 100,000.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:104686.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">For HCV we screened ten million donations and had</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104712.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">more than 3000 positives, for a frequency of 32 donations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104738.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">per 100,000.  Since we have just started HBV, we have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104765.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">screened 2.5 million donations, with a frequency of 11</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104792.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donations per 100,000.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:104818.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:104845.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">What I did next was to look at all of the PCR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104871.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">positive donations out of the six million screened, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104897.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">look at PCR only to see how many we would pick up just with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104924.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">PCR.  We picked up 84 out of six million, which gives a 50</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104951.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">percent increase over what we would have gotten with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:104977.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antigen alone.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:105003.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I also looked at PCR plus antibody.  We were able</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:105029.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to detect 33, and we are calling these true positives</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:105056.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">because we got confirmation that the donor was actually</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:105083.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">positive.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:105109.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Over here, what I have labeled as false positives</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:105135.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">would be the donations that were p24 antigen positive only.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:105162.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I am very pleased to hear that we may be able to reenter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:105188.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">these donors that were deferred.  They may be reentered</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:105215.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">into our program.  We detected 837 antibody positive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:105336.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:105372.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:106048.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:106059.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:106069.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:106080.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:105398.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donations, and we really don't know if they are true</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:105425.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">positives or not.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:105452.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:105478.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In conclusion, I just want to say that with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:105504.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">minipool testing we have been able to detect donations that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:105530.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">were positive and not positive by antigen and antibody, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:105557.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">we have reduced the window period donations of our</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:105584.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">manufacturing pools and, hopefully, eliminated many high</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:105610.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">titer units.  Any questions?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:105637.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Dr. YUWEN:  Any questions or comments?  Keep it</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:105663.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">short, please.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:105689.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. GALLARDA:  What was your test of record for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:105716.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">surface antigen?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:105743.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. PEDDADA:  What was what?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:105769.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. GALLARDA:  What was your test of record for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:105795.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the surface antigen EIA?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:105821.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. PEDDADA:  Genetic Systems.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:105848.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. YUWEN:  I would like to remind anybody from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:105875.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the audience to please identify themselves when they ask</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:105901.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">questions.  Thank you, Lorraine.  Our next speaker is Dr.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:105927.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Donald Baker, from Baxter.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:319.50pt;top:105953.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Baxter</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:105980.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:106007.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. BAKER:  This may seem like deja vu to you</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:106034.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">because you are going to see two Baxter presentations, but</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:106128.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:106164.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:106840.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:106851.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:106861.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:106872.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:106190.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">this is the Baxter on this side of the Atlantic as opposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:106217.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to the Baxter on the other side of the  Atlantic, which is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:106244.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">going to be the next one.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:106270.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:106296.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I am going to be looking at this from the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:106322.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">perspective of a manufacturer.  I am not going to talk</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:106349.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">about PCR test details because I am, frankly, not competent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:106376.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to speak about that.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:106402.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In the integration of the PCR, we integrated in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:106429.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">two places in the manufacturing process, one is the donor</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:106455.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">screening and the second is the production pool.  Now, from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:106481.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">a manufacturer's perspective, which is not necessarily</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:106508.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">shared by regulatory agencies, our objective is to get a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:106535.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">low defined level of viral burden in the manufacturing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:106561.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">pool.  That is not considered primarily a donor screening</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:106587.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">test.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:106613.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:106640.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In the resolution of the results, the information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:106667.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">flow is, of course, critical and this is something that we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:106693.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">won't get into in this presentation but I just wanted to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:106719.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">illustrate the complexity of the flow of the results.  We</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:106746.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">use NGI as our NAT testing lab and you can see between the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:106772.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">centers, many of these which are contract centers to us,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:106799.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">there is a tremendously complicated flow of information.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:106826.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:106920.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:106956.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:107632.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:107643.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:107653.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:107664.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:106982.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I am going to present our integrate summary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107009.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">which, for HCV and HIV, will be from 1998 to June of 2001.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107036.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">It will include both the qualified, that is donors who have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107062.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donated at least twice successfully, as well as the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107088.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">applicant donors.  In the first half of this year applicant</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107114.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donors represented about 11 percent of the PCR positives,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107141.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">just to give you some sense of their contribution.  So, for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107168.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HCV in a little over 5.2 million donations we found 894</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107194.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">positive and that represented 313 donors.  Obviously,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107221.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">because of the short time between donations, an individual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107247.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donor might contribute two or three positive donations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107273.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">before they are deferred.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:107300.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:107327.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">For HIV, again we started HIV and HCV testing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107353.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">simultaneously, we turned up 14 positive donors.  During</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107379.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that time period and still to date we are continuing to do</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107405.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">p24 testing.  Had we not done p24 testing in those five</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107432.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">million donations, we would have had approximately another</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107459.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">30 individuals who were only p24 positive who would have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107485.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">come into the PCR testing.  So, that gives you some sense</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107511.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of the number of individuals that the p24 test is excluding</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107538.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for us at present.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:107564.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:107591.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">For HBV, there are times when it is better to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107618.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">lucky than good.  Initially, when we were looking at HBV we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:107712.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:107748.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:108424.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:108435.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:108445.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:108456.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107774.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">considered that it might be possible or more economical not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107801.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to do HBV testing and just throw out positive pools.  I am</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107828.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">very glad that we did not take that approach because, as it</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107854.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">turned out, our HBV positivity in PCR was much higher than</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107880.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">we had initially anticipated and it would have been very</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107906.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">uneconomical not to do HBV testing.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:107933.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:107960.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Finally, here are our PCR positives with time.  I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:107986.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">wouldn't read a lot of meaning into the apparent increase</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108013.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">with time with some.  A lot depends on how fast your PCR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108039.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">turnaround is, and our PCR turnaround has become more rapid</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108065.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and, consequently, since we exclude our EIA positive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108092.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">results, we have had less chance with EIA testing to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108119.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">exclude individuals so we have had more individuals enter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108145.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the system, which is why the PCR positivity has seemed to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108171.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">increase in some circumstances.  It also is predicated on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108197.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">changes in collections practices and addition of new</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108224.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">centers and the increasing number of donations.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:108251.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:108277.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Finally, the system works.  It is robust and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108303.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">reproducible.  We have never had a positive manufacturing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108330.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">pool, touch wood.  It is timely.  We have been able to, of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108356.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">course, complete all the testing and donation resolution</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108383.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">within our 60-day inventory hold.  And, it has had a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108410.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">minimal impact, at least in terms of deferred plasma.  We</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:108504.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:108540.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:109216.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:109227.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:109237.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:109248.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108566.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">have approximately 1000 donations or so that have been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108593.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">discarded in this period of time.  Thank you.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:108620.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. YUWEN:  Thank you.  Are there any questions</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108646.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for Donald?  Michael?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:108672.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. BUSCH:  Mike Busch.  It was interesting to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108698.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">hear that you do test your applicant donors and you sort of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108725.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">separate your yield in applicant versus registered.  On a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108752.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">per donation basis, what is the rate of NAT only in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108778.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">applicant versus the registered donors?  This would give</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108805.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">you a sense of the relevant incidence in these first-time</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108831.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">applicant donors versus your regular repeat donors.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:108857.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. BAKER:  You know, Mike, I know where you are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108884.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">coming from but I don't think I can address the question</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108911.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">because, don't forget, we do our EIA and antigen screening</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108937.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">first so they all get kicked out.  So, of the PCR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108963.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">positives, for the first half of this year there was only</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:108989.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">about 11 percent that were applicants.  But I don't know</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109016.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">what the EIA positivity among the applicants is.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:109043.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. BUSCH:  What percentage of all accepted</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109069.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donations are from applicant versus regular registered?  Do</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109095.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">you have a sense of that?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:109122.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. BAKER:  We don't accept applicant donations.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109148.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Right?  So, they have to donate twice before we accept</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109175.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">them.  I can't give you the answer you want.  We don't</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109202.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">collect our data that way.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:109296.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:109332.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:110008.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:110019.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:110029.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:110040.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:109358.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. BUSCH:  Thank you, Donald.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:109385.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. YUWEN:  Our next speaker is Dr. Gerald</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109412.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Zerlauth, representing BaxterHylandImmuno.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:276.75pt;top:109437.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">BaxterHylandImmuno</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:109464.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. ZERLAUTH:  Thank you.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:109490.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:109517.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is the other part of Baxter's activities,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109544.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">comprising actually both sides of the world.  We are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109570.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">collecting plasma in the United States, pooling it in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109597.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">United States and sending it over to Europe.  So, this HIQ</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109623.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">PCR IND approach is a truly global activity.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:109649.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:109676.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">As I said, we are collecting our plasma in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109703.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">U.S. in community bioresources plasma centers, 23 centers</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109729.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">which bring about one million liters of plasma per year.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109755.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">These donations and serology samples are sent to Hoover,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109781.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Alabama for serology testing, while the PCR vials are going</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109808.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to the pooling lab in Round Lake, north of Chicago.  These</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109835.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">samples are pooled upon the arrival of the serology data.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109861.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, we are only pooling serology non-reactive sample into</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109887.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">pools of 512, according to the scheme already seen in pools</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109914.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of 512 individual donations.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:109940.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:109967.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">These the PCR pools, the master pools are then</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:109994.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sent to Vienna in a daily approach by airplane and are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:110088.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:110124.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:110800.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:110811.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:110821.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:110832.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110150.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">tested in Vienna with a test system which we call HIQ PCR.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110177.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Most of you know it.  It is the same for HIV, HCV and HBV</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110204.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">RT or PCR, depending on the virus.  It is a laser-induced</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110230.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">fluorescence detection system based on size-dependant</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110256.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">separation on polyacrilomide gels.  We have an internal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110282.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">standard which we termed the internal quality marker.  The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110309.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">tests are validated as qualitative tests, and these tests,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110336.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of course, are tested against all available genotype panels</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110362.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">and are validated according to the guidelines that have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110389.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">been cited several times this morning, in Europe and, of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110415.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">course, against the FDA guideline and, of course, against</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110441.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">all the panels that have been released by the FDA.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:110468.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:110495.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, overall, the sensitivities are now in IU and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110521.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">not calculated but tested against WHO standards,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110547.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">calibrated, as given here, HBV, 11 IU/ml; HCV, 24; and HIV-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110573.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">1, 65.  Just to complete, we also include parvo B19 which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110600.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">has 34 IU/ml, which is a quantitative assay; and HAV, with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110627.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">157 what we call Baxter units because we are lacking an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110653.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">international standard at the moment.  Just to avoid genome</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110679.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">or other equivalence we have Baxter units which will be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110706.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">replaced as soon as we have a WHO international standard.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:110732.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:110759.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">The results, as we are a newcomer in this IND</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110786.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">business, we only started in April and we have done 540,000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:110880.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:110916.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:111592.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:111603.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:111613.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:111624.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110942.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donations so far in about 1000 pools, and we have seen 13</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110969.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">positive pools for HCV, one for HBV and none for HIV.  In</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:110996.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">terms of donations, we have 13 donations but these 13</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111022.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donations were from three individual donors that we could</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111048.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">identify in this process and, obviously, one donor a non-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111074.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HIV.  So, I think we have to carry on until we get the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111101.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">necessary number to calculate the numbers as we have seen</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111128.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">them previously.  Of course, we are going to use depository</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111154.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">samples to increase the number of positive pools and show</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111181.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that the system works.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:111207.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:111233.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, this is actually what I have to show at the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111260.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">moment, and I hope next time I have more conclusive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111287.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">results. Thank you for your attention.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:111313.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. KLEINMAN:  Steve Klienman.  Just a very quick</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111339.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">question, is this a triplex assay or three individual PCR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111365.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">assays?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:111392.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. ZERLAUTH:  These are three individual PCR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111419.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">assays and extraction as well for two.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:111445.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. BUSCH:  Mike Busch.  A clarification, so the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111471.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">plasma that you are testing is a separate collection</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111498.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">system, separate centers from Baxter U.S. is collecting?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:111524.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. ZERLAUTH:  It is a Baxter owned group of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111551.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">plasma centers.  We just used those because we have those</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111578.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in our European files and we can use that plasma in Europe</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:111672.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:111708.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:112384.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:112395.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:112405.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:112416.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111734.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">as well.  So, we get the million liters for testing and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111761.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">most of it for use in Europe.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:111788.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:227.05pt;top:111788.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">BUSCH:  It is completely separate collection</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111814.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">from what Don Baker was talking about?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:111840.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. ZERLAUTH:  Don Baker's is contained in this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111866.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to some degree.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:111893.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">DR. YUWEN:  Our next speaker is Barbara Masecar,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111920.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">representing Bayer.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:323.25pt;top:111945.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Bayer</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:111973.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">MS. MASECAR:  Thank you for the opportunity to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:111999.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">present this afternoon.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:112025.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:112052.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">I would like to briefly give you a summary of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112079.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NAT donor screening at Bayer Corporation.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:112105.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:112131.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This is a recap of where we are right now.  All</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112157.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of our donations are currently screened for the big three,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112184.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HCV, HIV and HBV and we are also doing in-process testing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112211.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for parvovirus B19 by NAT.  Currently, HCV, HIV and parvo</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112237.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">testing is Bayer's Raleigh test laboratory in North</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112263.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Carolina and that is on a 96-sample minipool format.  The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112290.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HBV testing is performed at NGI on master pools, if you</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112316.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">will, of 480 samples that are prepared at the Raleigh test</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112343.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">lab and then sent to NGI, in Los Angeles.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:112464.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:112500.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:113176.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:113187.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:113197.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:113208.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:112526.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Today I will be giving you summaries of the HCV,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112553.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HIV and HBV, and my colleague, Todd Gierman, will be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112580.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">presenting the parvovirus data later on today.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:112606.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:112632.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">As far as HCV goes, we began testing in September</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112658.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">of 1997 and we have been using the Roche AmpliScreen</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112685.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">microwell plate method.  We began enrolling follow-up study</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112712.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donors that were found to be NAT positive and antibody</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112738.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">negative in 1997, and we continued that enrollment until</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112765.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">January of this year.  During that time frame we screened</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112791.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">6.5 million samples representing 385,000 donors</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112817.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">approximately.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:112844.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:112871.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">During that time we discovered and identified 383</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112897.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NAT positive, antibody negative donors.  I want to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112923.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">underscore here that this was as judged by the Abbott EIA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112949.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">version 2.0 test.  Of these  283, 289 were qualified; 94</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:112976.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">were applicant.  We were able to enroll 152 into the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113003.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">follow-up studies, which is 24 weeks in our program.  We</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113029.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">found that compared to EIA 2.0 the reduction in the window</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113055.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">period was 66 days.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:113082.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:113108.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We provided 71 of the sample panels from follow-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113135.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">up to Leslie Tobler, Blood Centers of the Pacific, for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113162.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">further study, and she, among other things, retested these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:113256.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:113292.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:113968.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:113979.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:113989.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:114000.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113318.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">panels with the Chiron version 3.0 EIA test.  What she</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113345.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">found was that in 42 of the 71 panels seroconversion did</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113372.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">not occur simultaneously with the version 2.0 and 3.0.  As</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113398.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">you might expect, in those cases where there were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113424.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">discordant results seroconversion with the 3.0 preceded</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113450.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">seroconversion by 2.0 by a median of 17 days.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:113477.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:113504.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In 55 of the 71 panels that Dr. Tobler tested the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113530.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">index donation showed concordant negative results with both</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113557.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the version 2.0 and 3.0.  So, the index donation being the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113583.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">first NAT positive donation was, indeed, negative with both</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113609.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">versions of the EIA test in 77 percent of these panels.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113636.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">However, in 16 of these panels, or 22 percent, the index</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113663.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donation was actually positive with version 3.0.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113689.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Interestingly, two of the 16 we followed for about six</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113715.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">months, and with version 2.0 there was never a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113741.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">seroconversion.  One of these was RIBA positive, one was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113768.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">RIBA indeterminate, but in our program we don't test RIBA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113795.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">unless the EIA is positive.  So, we didn't have an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113821.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">indication prior to this work that the RIBA was positive.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:113847.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:113874.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Of 383 of those donors that were identified as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113900.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NAT positive and antibody negative, 23 of the study</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113927.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">participants were negative for all tests upon follow-up.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:113954.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">This could be assumed to be due to false-positive NAT, but</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:114048.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:114084.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:114760.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:114771.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:114781.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:114792.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114110.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">the more likely reason is low level contamination during</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114137.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">collection, processing or testing.  In 1997, when that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114164.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">screening began at Bayer, at about that same time we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114190.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">changed to an open tube drain and drip method for sample</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114216.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">collection.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:114242.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:114269.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, we got wise to that; that wasn't the way to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114296.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">go.  So, we reinstituted closed sample collection in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114322.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">November of last year.  Also, early on we changed lab</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114349.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">processes so that multiple positives from a single minipool</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114375.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">are always confirmed from a backup sample.  So, since</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114401.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">February of '99 all HCV and HIV positives are confirmed by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114428.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">backup samples if they are not the sole positive in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114455.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">minipool of '96.  So, four of the 93 were collected prior</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114481.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">to February of '99 and one, perhaps two, were collected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114507.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">after the implementation of closed sampling.  There is some</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114533.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">conflicting information from the plasma centers on that.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114560.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Unfortunately, we stopped enrolling -- well, fortunately or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114587.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">unfortunately, we stopped enrolling donors in the following</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114613.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">January.  So, in the time frame to collect it -- there is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114639.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">no data -- is quite short.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:114666.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:114692.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Switching to HIV now, we also use the Roche</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114719.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">AmpliScreen HIV microwell plate method.  The testing began</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114746.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">in September of 1999, and we ended follow-up study</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:114840.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:114876.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:115552.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:115563.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:115573.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:115584.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114902.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">enrollment in April of this year.  During that time we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114929.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">screened about four million samples, representing 200,000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:114956.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donors.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:114982.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:115008.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">During that follow-up study period we identified</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115034.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">23 donors that were positive by HIV NAT only and seven</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115061.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donors that were positive for both NAT and p24.  This is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115088.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">how it falls out as far as applicant and qualified as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115114.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">defined by ABRA, three of the NAT positive only donors were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115141.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">applicant and 20 were qualified, and all of the donors that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115167.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">were positive for NAT and antigen were qualified donors.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:115193.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:115220.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We enrolled nine of the NAT positive, antibody</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115247.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">negative donors into the follow-up study and what we found</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115273.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">was that the reduction in the window period relative to p24</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115299.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antigen was six days, with an N of 14, and nine days</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115325.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">relative to antibody, with an N of eight.  So, you can see</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115352.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">by these numbers that we also had some additional data from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115379.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">subsequent donations from donors that were not enrolled in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115405.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">follow-up.  Indeed, all of these nine did confirm upon</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115431.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">follow-up.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:115458.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:115484.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Just a slide about assay performance in our</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115511.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">hands, the AmpliScreen HCV assay has about a 1.5 percent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115538.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">positive control failure rate and a 0.5 percent negative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:115632.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:115668.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:116344.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:116355.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:116365.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:116376.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115694.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">control failure rate.  For HIV, it is somewhat better.  It</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115721.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is 0.8 percent positive control failure rate, with less</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115748.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">than 0.1 percent negative control failure rate.  This</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115774.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">compares quite favorably to some data that we have from our</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115800.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">own viromarker test laboratory when it was in operation, in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115826.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">1997, of 2.4 for positive control failures and 1.1 percent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115853.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">for negative control failures.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:115880.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:115906.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">HBV by NAT -- as I mentioned, the testing is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115933.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">performed at NGI on pooled samples that are prepared by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115959.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Bayer.  We began testing in July of 2000.  We ended follow-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:115985.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">up study enrollment the following August.  During that time</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116012.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">we tested 349,000 samples, representing 45,000 donors.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:116039.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:116065.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">We identified 19 donors as NAT positive and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116091.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">surface antigen negative.  We enrolled ten in the follow-up</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116117.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">study and the average reduction in the window period was 11</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116144.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">days relative to surface antigen.  Again, the N is 7.  That</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116171.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">is comprised of four participants of these ten, and three</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116197.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">that we got data from subsequent donations.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:116223.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:116250.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">So, of those ten that were enrolled in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116276.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">follow-up study, as I said, four were subsequently surface</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116303.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antigen positive.  However, six did not test surface</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116330.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">antigen positive during the follow-up study.  Four were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:116424.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:116460.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">sgg</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:267.75pt;top:117136.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">MILLER REPORTING COMPANY, INC.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:284.25pt;top:117147.15pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">735 8th Street, S.E.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:264.75pt;top:117157.65pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">Washington, D.C. 20003-2802</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:301.50pt;top:117168.90pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.75pt">(202) 546-6666</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116486.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">anti-core positive, and that was after following them for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116513.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">12 to 14 follow-up samples.  All those were positive the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116540.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">first time we tested them for core but it was already when</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116566.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">they were in follow-up.  Two were negative for all</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116592.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">subsequent tests, and that was HBV NAT, surface antigen,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116618.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">anti-surface antigen and anti-core.  For one of these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116645.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">donors we only had one follow-up study and the other one we</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116672.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">followed for 29 weeks basically, but they were negative.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116698.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Interestingly, both of these were from the same plasma</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116725.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">center, collected a day apart.  So, I am not sure what that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116751.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">means but it is coincidental.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:116777.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:116804.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Follow-up HBV NAT data for three of the four</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116831.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">surface antigen positive, anti-core negative donors was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116857.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">intermittent during follow-up period, and it may be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116883.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">indicative of a preexisting low-level HBV infection, as was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116909.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">already presented.  Further characterization of follow-up</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116936.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">samples for these HBV follow-up donors is in progress at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:116963.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">NGI.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:116989.25pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">[Slide]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:198.00pt;top:117015.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">In conclusion, I would like to acknowledge some</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:117042.50pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">folks that helped me with the data presented here, Eleanor</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:117068.75pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Davis, Sue Banazek, Matthew Nicosia from Bayer, Leslie</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:117095.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">Tobler from Blood Centers of the Pacific and Rich Smith</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:126.00pt;top:117122.00pt;z-index:3;"><FONT FACE ="Courier New" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 12.00pt">from NGI.  Thank you for your attention.</FONT></FONT></FONT></SPAN>
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