AOAC Gluten Quantitative Validation Guidance-Round 1(Nov 2023)

should be reported as Below the Limit of Quantitation (BLQ). Percent recovery should be calculated and reported for the mean concentration from each gluten source. If any analysis is repeated, all datasets must be reported and a justification given for all repeat analysis. As the Breadth study is purely informational, there are no acceptance criteria, but method developers may choose to point out any of the less common gluten-containing grains that demonstrate recoveries below 50%, in the method instructions. Page 5, Section 4.3, Cross-reactivity: Most of the commodities for Cross-Reactivity and Interference Studies of Annex A,Table 2 are flours. In case of a matrix (flour) tests above the method LOQ, the use of the same matrix in grain/bean format and ground in the method developer's lab to rule out contamination during the flour manufacturing process should be contemplated. The following was added as a footnote to Annex A: “If any of the matrices purchased as a flour are demonstrating unexpectedly high results, it may be necessary to purchase that material in a whole grain/seed/bean form and grind it in your own lab, in order to get a clean material that will give you a true estimation of cross-reactivity.” Page 6, Section 4.3, Interference : Delete "extrapolated", since extrapolation is not necessary for results above the LOQ. Deleted Page 6, Section 4.3, Interference : Does the paragraph in blue make sense in the Interference section? [I could not see the color coding, but perhaps it refers to this paragraph- “If a result is obtained that is above the measurement range of the method, the extract must be diluted and rerun to obtain the exact amount of analyte.”?] Edited, now reads “If a result is obtained that is above the measurement range of the method, the extract must be diluted and re-analyzed. “ Page 6, Section 4.4 Matrix Study : I think that Table 1 and Table 2 descriptions are under the wrong table each. Switched back to the correct places Page 7, Matrix Study Design, Table 3 : Parameter Column has a parameter called "Sensitivity" but there are no parameters in the document. I search in the document for this word, and it seems it is being used as a stand-in for LOD/LOQ concept. In Table 3 here, I'd ask to change this line to "LOD/LOQ" instead of "Sensitivity." Rationale: In other docs, "Sensitivity" is used as a stand-in for other concepts, like recovery, or the strength of response. I would avoid it in this document, since we have defined LOD and LOQ, and I can't see adding a definition for Sensitivity. Also, in places in the text where "sensitivity" is used, delete. Page 7, Matrix Study Design, Table 3 : Definition of Sensitivity? Sensitivity changed to LOD/LOQ throughout document