September 2015 SPADA Meeting

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

Briefly explain why AMIL rather than the usual AMDL. The implication seems to be that any VEEV detection method may not be specific as to 1AB, 1C and 1D variants (serovars). State the mandatory number of matrices for system false +/- rates testing.

Propose to add additional language to the POI definition specifically stating that acceptable methods must be able to identify the individual

17 & 53

serovars in table II.

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." Propose to add language to Table III: Inclusivity Panel that: "One representative strain from each serotype is sufficient."

53

State if all the 9 inclusive strains are

mandatory or not.

64

The VEEV subtype ID strains listed do not represent the entire genetic diversity known. I can recommend additional strains or substitutes

For discussion.