AOAC has published new food allergen validation guidelines for immunoassays. This guidance supersedes the guidance originally developed by the AOAC Food Allergen Community and is included in the OMA as Appendix M.
This comprehensive document includes specific details on how to set up specific studies, testing materials, and statistics. The guidelines are available as OMA, Appendix M.
The standard guidance was drafted under the AOAC Gluten and Food Allergens (GFA) program by the WG on Food Allergens.
The AOAC GFA program was launched in 2021 with the development of validation guidelines for both food allergen and gluten methods. Two working groups were formed: Food Allergens WG and Gluten WG.