AOAC ISPAM Food Allergen WG Meeting Book (12-15-16)

AOAC ISPAM "Food Allergen" Working Group Questions/Comments Form Submission ID 357553503668955068

Submission Date

2016-12-14 14:38:23

Submission IP

184.105.48.66

First & Last Name

Paul Wehling

Organization

General Mills, Inc.

E-mail Address

paul.wehling@genmills.com

Per LOD/LOQ definitions in the SMPR - I note that Appendix M includes these definitions. We should harmonize the SMPR to Appendix M. LOD is defined as the lowest concentration or mass of analyte in a test sample that can be distinguished from a true blank sample at a specified probability level. LOQ is the lowest level of analyte in a test sample that can be reasonably quantified at a specified level of precision. Per discussion of including cross-reactivity in the SMPR. Appendix M does discuss this. Perhaps good language in the SMPR would be such like - "Cross-reactivity has been investigated as per Appendix M. Method developers should submit cross-reactivity data and include any notable observations." or something like that.

Question/Comment-1

Question/Comment-2

The concept of trueness for an ELISA method is difficult to define, let alone experimentally estimate. We did discuss this on the last call. I think it is important for the developer to evaluate and describe the protein sequences that their antibodies (or other agents) bind to.

Question/Comment-3

Question/Comment-4

In terms of measuring trueness, there should be some attempt made to evaluate this.

For LOD/LOQ, LOD criteria should be lower than the LOQ criterion. I'd expect the procedures described in Appx M to be used.

Question/Comment-5

Question/Comment-6

Criterion for recovery should be symmetrical about 100%, e.g., 60-140%