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

4.1.8 Method Instructions …

Details should be provided on result interpretation. For example, in kits where color change is a factor, end users should be directed on when to call a result positive based on color intensity. In this area as well, pictorial examples are encouraged. Include details on the reporting of results (positive, negative, < > the CDC, detected/not detected at the CDC, etc.), name of method, the units (wheat protein, gluten, gliadin, etc.), and the method for converting all results to gluten values. The instructions must clearly outline any known limitations of the method, including any sources of gluten that are not detected by the method, any known under- or over-sensitivity to specific gluten sources, cross-reactivity or interference from any matrices, and information on specific fractions/proteins targeted . … Proposed New Text: Include the name of the method and details on the reporting of results relative to the CDC expressed in mg/kg gluten (e.g. positive, negative, < > the CDC, detected/not detected at the CDC, etc.) Justification: Qualitative tests should be described in reference to their CDC as expressed in gluten mg/kg not in other units such as wheat protein or gliadin concentration. All relevant regulations are expressed in mg/kg, so other units add confusion. mention of gliadin conversion – since all test materials in the study will be from flour (not extracted proteins) all units for concentration will be in gluten units, not gliadin x2 – I think this should be removed. Should add to this: “For this document, all concentrations shall be reported in units of gluten.”