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

Page 10, Product Consistency and Stability : 6 th paragraph “For the product stability and consistency study, there should be no significant (P<0.05) differences between test kit lots and effect of storage time.” Is there actually enough replication to determine significant time/age difference? It might also be possible that there is a significant difference between time/age of kits, but that older kits still meet all statistical requirements _and_ perhaps even perform closer to true on recoveries for certain sources. Removed the 0.05 criteria, this section now reads “Results should be analyzed to determine mean results, repeatability standard deviation, and recovery for each lot. These estimates must all meet acceptance criteria for all lots tested. If product stability and consistency are included in a nested design for the matrix study, data should be analyzed according to the ANOVA procedure outlined in Annex D. “ Page 10, Section 4.8, Method Instructions : Delete "as well as links or references to this training". This is certainly the responsibility of the laboratory and not the method provider. Deleted, this point now reads “Specific qualifications or training required to perform the method.” Page 11, Section 5.2 : Add that the rotation of the claimed gluten sources should follow tables 1 and 2, similar to the reference made for the collab study (6.3). Added, the first sentence now reads “At minimum, the independent laboratory must analyze at least one matrix for every five matrices evaluated in the Method Developer Study (Table 4), following the rotation of claimed gluten sources shown in Tables 1 or 2, depending on the method claims.” Page 11, Collaborative Study : Renumber Collaborative (Interlaboratory) Study. (Currently listed as 5, but previous section was 5.). Fixed Page 11, Collaborative Study : Change the number from 5 to 6; 5 is the independent laboratory. Fixed Page 11, Section 6.1 : Consider to add that participating labs can/should receive a training by the method developer prior to participation, similar to the qualitative document. Added the sentence “Method developers may provide training on the test method to collaborator sites. “ Page 11, Section 6.4 : Add "gluten source" to the sentence ... material is defined as a combination of the test component, matrix, and concentration ... or specify else Added and took out test component, so this sentence now reads “For the purposes of this requirement, a test material is defined as a combination of the matrix, gluten source and concentration to which the method performance parameters apply.” Page 11, Section 6.4 : As regards the use of a minimum of 5 materials and for the sake of clarification, could an example be provided?