AOAC GFA Stakeholder Program Meeting Book (March 15, 2023)

1 Scope The purpose of this document is to provide comprehensive technical guidelines for conducting validation studies for qualitative gluten methods, for example methods submitted for AOAC INTERNATIONAL (AOAC) Performance Tested Methods SM (PTM) status and/or for AOAC Official Methods of Analysis SM (OMA) status. The requirements for method developer (single-laboratory) validation studies, independent validation studies, and collaborative validation studies are described. Specific examples are provided for lateral-flow devices. 2 Applicability These guidelines are intended to be applicable to the validation of candidate qualitative gluten methods, whether proprietary or non-proprietary, including those that may be submitted to AOAC for OMA status or PTM certification. Unforeseen circumstances may necessitate divergence from these guidelines in certain cases, and these must be reviewed by AOAC or another appropriate agency (other than the method developer). The AOAC PTM Program requires a method developer (single-laboratory) validation (SLV), and an independent laboratory study. The AOAC OMA Program requires an SLV (also known as the pre collaborative study) and a collaborative study to achieve Final Action status. A harmonized PTM-OMA Program can be followed in which PTM certification is sought and, if successful, serves as the SLV phase of the OMA Program. The current document lacks clarity regarding oats as a gluten free food. Many nations that allow gluten free claims allow oats in gluten free foods so long as gluten contamination from wheat, barley, or rye is equal to or below 20mg/kg (depending on the specific regulation by country). Additionally, oats have been excluded from the definition of gluten in previous AOAC documents (SMPR 2017.021). In light of the important role of oats in the diet of Celiacs, we propose this text for the Applicability section as follows: These guidelines are intended to be applicable to the validation of candidate qualitative methods for the detection of gluten from wheat, barley, rye, their crossbreeds, and/or their derivatives. Many nations that allow gluten free claims allow oats in gluten free foods so long as gluten contamination from wheat, barley, or rye is equal to or below 20 mg/kg (depending on the specific regulation by country)… Why do we have Scope and Applicability? For me both are quite comparable and can be merged in one chapter.