AOAC Gluten Qualitative Validation Guidance-FINAL (July 2023)

Gluten Working Group Comments/Responses (Round 1)

• This is misleading because the whole document is titled "Guidleines for validation of qualitative gluten methods...."; proposal: Change to "validation" o The heading has been changed to read Method Validation 4.1.1 Scope second paragraph last sentence • This may need to be altered pending decision on matrix study. o This last sentence of the Scope may have veered too far into methods. The wording has been changed from “ Developers must determine which of these sources and levels their method is intended to detect, and perform individual interference and POD studies for each claimed gluten source at each claimed detection capability (CDC).” to “Developers must determine which of these sources and levels their method is intended to detect, and perform interference and POD studies for each claimed gluten source.” • Add “table 2” after Annex A o Added 4.1.2 first paragraph “cross reactivity study be performed on environmental surfaces” • A bit unclear on cross-reactivity for environmental surfaces. What should be evaluated for cross reactivity in a way that's different from the POD/Matrix study? o This is included for methods that may be designed only for surface swabbing, and that don’t have steps or reagents for sample extraction. I don’t think this applies to any current methods, but I think of something like the 3M CleanTrace for protein, and if someone ever developed a method like that for gluten. 4.1.2, second paragraph “Any AOAC OMA method for gluten • That has claims for these gluten sources. Is AOAC OMA required or is AOAC PTM sufficient? What if there are no OMA methods that meet this requirement. o This statement was simply a suggestion, as there are no ‘reference’ methods for gluten. The current OMA methods are, empirically, able to detect gluten from wheat, rye and barley, although they having differing affinity to each gluten source. To avoid ambiguity, this paragraph has been removed. 4.1.2 second paragraph “unintended wheat, rye and barley” • If this is a requirement, the OMA method or any other accepted reference method, should have claims for the detection of these three gluten sources. o There are no gluten reference methods, so as mentioned above, this paragraph has been removed. 4.1.2, Interference first paragraph “or two times the environmental surface detection limit…” • How would this be done? And how would it be different than the POD study? 4.1.2 first sentence