AOAC Gluten Qualitative Validation Guidance-FINAL (July 2023)

Gluten Public Comments (Responses)

4.3.3. Matrix Study Collaborative Study Since we (absolutely justified) put a lot of emphasis on the necessity to test incurred matrices, at least one incurred matrix tested by the independent laboratory for PTM and at least one incurred matrix tested in the collab study should also be prepared by an independent entity (according to a recipe provided by the method developer). This has been addressed in section 4, which now includes a section reading “Ideally, all test materials for the independent laboratory and collaborative studies should be prepared by an external entity independent from the method developer. At least one incurred test material for the independent laboratory and collaborative studies must be prepared by an external entity independent from the method developer. In situations where an independent entity is unavailable to prepare all of the test materials for the independent laboratory and collaborative studies, or their use is impractical for all test materials, method developers may produce and distribute test materials as long as detailed information is provided on procedures used to prevent bias (preparation, coding, etc.), and justification is provided for failing to use an independent entity to prepare all of the test materials.” ------------------------------------------------------------------------------------------------------------------------------------------ 4.3.4 There is brand-new ISO DTS 27878 on Reproducibility of the level of detection (LoD) of biary methods in collaborative and in-house validation studies; This TS should not only be cited but included in the guideline as an alternative source for statistics This reference has been added in the third paragraph of the section, which now reads “Calculate repeatability and reproducibility as described in Wehling et al. 2011. Additional guidance for calculating reproducibility and limit of detection from the collaborative data can be found in ISO/TS 27878:2023.”, and also into the list of references under section 3, Terms and Definitions. ------------------------------------------------------------------------------------------------------------------------------------------ 4.3.4 "To calculate repeatability and reproducibility as described in Wehling et al. 2011" is more than 12 years old; meanwhile a lot more approaches were published and should cited as alternatives A note has been made in the document to replace this reference with an upcoming publication in JAOAC ------------------------------------------------------------------------------------------------------------------------------------------ References ISO 16393 should also be added as a reference. It is the sister document to AOAC's Appendix N. Reference added under section 3, Terms and Definitions ------------------------------------------------------------------------------------------------------------------------------------------