September 2015 SPADA Meeting

Comments

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Proposed Response

Are these System False Negative and Positive  Rates the same as those to be determined in  the presence of environmental matrix  materials as indicated in the Method  Performance Requirements Table  (unnumbered)?  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. Method Performance Table (unnumbered)  H S t F l P iti R t b

40‐46

That is correct.

The intent is that spiked and  unspiked environmental  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. 

Section 7

Comments

Line Numbers Comments

Proposed Response

Table II. 

Additional species suggested.

For discussion.

In the empty cells suggest  putting  "Investigator to choose strain(s)" if that is the Agree to insert "Investigator  intention. may choose strain(s)"

Table III