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Comments
Line Numbers Comments
Proposed Response
Are these System False Negative and Positive
40‐46
Rates the same as those to be determined in
the presence of environmental matrix
materials as indicated in the Method
Performance Requirements Table
(unnumbered)?
That is correct.
Method Performance Table (unnumbered)
H
S t F l
P iti
R t b
The intent is that spiked and
unspiked environmental
Section 7
ow can a ys em a se‐ os ve a e e
determined using spiked environmental
matrix materials if the spike is the target
organism? Seems like it should be False‐
Negative and the other rate without spike
should be False‐Positive.
matrix samples will be used
to evaluate false negative and
false positive rates
respectively. Propose to
revise Tavle IV Part 1 to clarify
this requirement.
Comments
Line Numbers Comments
Proposed Response
Table II.
Additional species suggested.
For discussion.
Table III
In the empty cells suggest putting
"Investigator to choose strain(s)" if that is the Agree to insert "Investigator
intention.
may choose strain(s)"