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

4 Method Validation Qualitative binary methods are those that produce one of two possible responses (as defined in AOAC Appendix N). This guidance has been developed for use with candidate methods that are designed to detect gluten. If a candidate method’s intended use is not covered by this document or existing standard method performance requirements (SMPRs), the standing AOAC expert review panel (ERP) for gluten, or other qualified agency, may determine the appropriate cross reactivity/interference panels, and performance requirements. Method developers may prepare study test materials in house for the single laboratory validation (method developer study), but all samples and test portions must be blind-coded and randomized. Analyses conducted by the method developer must be performed by an independent analyst without prior knowledge of the test materials undergoing analysis in a given sample set. Ideally, test materials for the independent laboratory and collaborative studies should be prepared by an external entity independent from the method developer. In situations where an independent entity is unavailable, method developers may produce and distribute test materials if detailed information is provided on procedures used to prevent bias (preparation, coding, etc.)

First sentence: Delete part in brackets because this is already mentioned in the definition part and should not be repeated throuhgout the document

"in house" should be hyphenated

Last sentence: Delete because this should not happen in reality; just giving detailed information does not prevent a misuse of these materials