Draft
June
2003
Cryptosporidium
Sample
Results
Acceptability
Checklist
for
the
LT2
Rule
No.
Factor
Check
sample
results
to
verify
that:
U
General
Requirements
1
Sample
condition
upon
receipt
The
sample
temperature
upon
receipt
for
the
sample
was
between
0
°
C
and
8
°
C,
and
the
sample
was
not
frozen
2
Sample
volume
The
volume
analyzed
for
the
sample
was
at
least
10
L
OR
at
least
2
mL
of
packed
pellet
volume
was
analyzed
OR
2
filters
were
used
and
clogged
and
100%
of
the
volume
filtered
was
analyzed
Holding
Time
Requirements
3
Sample
collection
The
elution
step
for
the
sample
was
initiated
within
96
hours
of
sample
collection
(
if
shipped
to
the
laboratory
as
a
bulk
sample)
or
filtration
(
if
filtered
in
the
field)

4
Sample
processing
The
sample
was
processed
(
eluted,
concentrated,
purified,
and
applied
to
the
slide)
in
one
working
day
5
Sample
drying
The
slide(
s)
for
the
sample
were
stained
within
72
hours
of
application
of
the
sample
to
the
slide
6
Sample
examination
The
slide(
s)
for
the
sample
were
examined
within
7
days
of
staining
Quality
Control
(
QC)
Sample
Requirements
7
QC
batch
The
ongoing
precision
and
recovery
(
OPR)
and
method
blank
samples
associated
with
the
sample
are
associated
with
no
more
than
20
field
and
matrix
spike
samples
and
no
more
than
a
week
of
samples
8
Method
blank
results
The
method
blank
sample
for
the
QC
batch
was
acceptable
(
no
Cryptosporidium
oocysts
or
potentially
interfering
materials
were
found
in
the
method
blank)

9
OPR
sample
results
The
OPR
sample
for
the
QC
batch
was
acceptable
(
recovery
was
at
least
24%)

10
Spike
levels
for
OPR
The
associated
OPR
was
spiked
with
no
more
than
500
oocysts
11
Spike
materials
for
OPR
The
spiking
suspension
used
for
the
associated
OPR
was
flowcytometer
sorted
Staining
Control
Requirements
12
Staining
control
frequency
A
positive
and
negative
staining
control
slide
is
associated
with
the
slide
for
this
sample
13
Positive
staining
control
result
The
positive
staining
control
for
this
sample
is
acceptable
(
it
contained
oocysts
within
the
expected
range
and
at
the
appropriate
fluorescence
for
both
FITC
and
DAPI)

14
Negative
staining
control
result
The
negative
staining
control
for
this
sample
is
acceptable
(
it
did
not
contain
any
oocysts)

Matrix
Spike
(
MS)
Sample
Requirements
15
Sample
volume
The
same
sample
volume
was
analyzed
for
the
MS
sample
and
the
associated,
unspiked
field
sample
16
Method
version
The
same
method
version
(
filter,
IMS,
staining
kit)
was
used
for
the
MS
sample
and
the
associated,
unspiked
field
sample
17
Spike
amount
for
MS
The
MS
sample
was
spiked
with
no
more
than
500
oocysts
18
Spike
materials
for
MS
The
spiking
suspension
used
for
the
MS
was
flow­
cytometer
sorted
