AOAC GFA Stakeholder Program Meeting Book (August 27, 2023)

5. Independent Laboratory Study 5.1 Scope PAGE ELEVEN – INDEPENDENT LAB STUDY

The independent laboratory validation study should verify the analytical results obtained in the method developer study in a controlled laboratory setting. The independent laboratory should verify the repeatability, intermediate precision, sensitivity, and recovery performance parameters of the method. 5.2 Matrix Study Incurred test materials are required for evaluation of repeatability, intermediate precision, sensitivity, and recovery. See Annex B for description of best practices for incurred test material preparation. At minimum, the independent laboratory must analyze at least one matrix for every five matrices evaluated in the Method Developer Study (Table 4). The independent laboratory must analyze at least one environmental surface/CIP solution for every five claimed. If both environmental surfaces and CIP solutions are claimed as matrices, and only one is to be included in the independent lab study, the environmental surface should be the chosen matrix. The selection of which matrices/surfaces/solutions are analyzed should be reflective of the range of difficulty associated with the claimed matrices. The study design, data analysis, and reporting for the independent laboratory study should follow the same requirements described in the Matrix Study section of the Method Developer Study (4.4).

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).

6.3 Matrix Study The collaborator sites will perform the matrix studies for each claimed gluten source in at least one of the incurred matrices for each matrix category claimed in the method developer study, following the rotation of claimed gluten sources shown in Tables 1 or 2, depending on the method claims. The selection of which matrices/surfaces/solutions are analyzed should be reflective of the range of difficulty associated with the claimed matrices.