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

3.5 Claimed Detection Capability (CDC) An analyte concentration, expressed in mg/kg of gluten (or mg per surface area), that demonstrates a Probability of Detection (POD) of at least 0.95. This may be claimed as one level that achieves a POD of 0.95 across all validated matrices, or individually per matrix. The claimed detection capability must be verified empirically during method validation. Proposed New Text: “An analyte concentration, expressed in mg/kg of gluten (or μg per surface area), that demonstrates a Probability of Detection (POD) of at least 0.95. This may be claimed as one level that achieves a POD of 0.95 across all validated matrices, or individually per matrix. The claimed detection capability must be verified empirically during method validation. In the case that multiple gluten sources are claimed, a CDC shall be declared for each source .” Justification: Antibodies are unlikely to have equal response across gluten sources. CDC’s should be selected to best represent kit performance for each gluten source. The document recognizes that you may have different CDC per matrix listed in kit insert, but what if it varies by gluten source as well? I’d actually anticipate this… in that case would the method developer have the same option? To list the highest CDC as a single value or to detail out the CDCs obtained per matrix/gluten source combo?