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SMPR Key Points
•
A separate SMPR is needed if identification of EEE
and/or WEE is desired.
•
Method defined as “molecular”; not limited to PCR.
•
Minimum genome copies/ml for the AMIL have
been standardized by AOAC. Reaction volumes are
at the discretion of the method developer.
•
Environmental matrix, environmental panel
organisms and potential interferants have been
standardized for SMPRS with similar intended uses.
Comments Submitted
Line
Numbers
Comments
Proposed Response
17 & 53
Briefly explain why AMIL rather than the
usual AMDL. The implication seems to
be that any VEEV detection method
Propose to add additional language to the POI
definition specifically stating that acceptable
methods must be able to identify the individual
may not be specific as to 1AB, 1C and
1D variants (serovars).
serovars in table II.
53
State the mandatory number of
matrices for system false +/- rates
testing.
This was purposefully left open and is covered
by the statement in table 4 part 1 that:
"Justifications for the selected conditions that
were used to generate the environmental
matrix and limitations of the validation based
on those criteria must be documented."
State if all the 9 inclusive strains are
Propose to add language to Table III:
64
mandatory or not.
Inclusivity Panel that: "One representative
strain from each serotype is sufficient."
The VEEV subtype ID strains listed do
not represent the entire genetic diversity
known. I can recommend additional
strains or substitutes
For discussion.