AOAC GFA Stakeholder Program Meeting Book (August 27, 2023)

Scope and Applicability

1. Scope The purpose of this document is to provide AOAC International (AOAC) guidelines for method developers conducting validation studies of immunoassay-based food allergen analysis methods, e.g., for submission for AOAC Official Methods of Analysis (OMA) status and/or Performance Tested Methods (PTM) certification. This document is not intended to describe requirements for laboratories using commercial immunoassay methods for food allergen analysis , though it may assist these laboratories in understanding the consensus-based validation approaches, terminology used, and information expected to be provided by method developers. 2. Applicability These guidelines are applicable to both quantitative and qualitative food allergen methods, of either a proprietary or non-proprietary nature.