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

AOAC ISPAM "Food Allergen" Working Group Questions/Comments Form

Submission Date

2016-12-07 15:47:29

First & Last Name

Girdhari Sharma

Organization

US FDA

E-mail Address

Girdhari.Sharma@fda.hhs.gov

Date Submitted

12-07-2016

Question/Comment-1

Title: As mentioned in the Chat, protein may be more appropriate than allergens, OR quantifying the egg as a commodity. It may be easier to convert between total protein and total egg based on known protein content in egg. One of the problem with quantifying allergens is to separate non-allergens from total proteins since the reference material will most likely have total proteins. This makes it difficult to calculate recovery of allergens. If changes made, it would also be need to be in Applicability section and Table 1. Title: The title should be modified to reflect the analytical technique section. Also since ELISA is a binding-based assay, it may not be specified separately if using a broader definition such as binding-based methods. Is the SMPR meant for protein binding- based or covers other techniques such as PCR as well? Line 50, LOD: would this be 90 or 95% certainty? LOD calculation is presented in Appendix M. Can the false-positive at minimum concentration of analyte be distinguishable from true-positive expected at the LOD concentration? The false- positive would be due to matrix interference.

Question/Comment-2

Question/Comment-3

Question/Comment-4

line 101, Validation Guidance: As discussed in the meeting, there should be provision for additional matrices if desired.

Question/Comment-5

line 122 Table 1: What is Matrix X and why separated from other matrices? As pointed in the meeting, LOD is typically lower than LOQ. Appendix M suggests recoveries of 50-150% as acceptable for incurred samples. Is whole egg referred to as allergen here (Note)? If not, reporting allergen from the material used in incurred samples would be difficult and vary depending on the antibody specificity.