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

PAGE ELEVEN – INDEPENDENT LAB AND COLLABORATIVE STUDIES

5. Collaborative (Interlaboratory) Study 6.1 Scope:

WORDING FROM QUALITATIVE DOCUMENT: 4.3 Collaborative Study 4.3.1 Scope The collaborative study evaluates the performance of the method across multiple collaborators. The collaborative study is a requirement of the AOAC OMA program, and is not required for the AOAC PTM program. Collaborators should receive training on the specific test method, which will be provided by the method developer. The method developer shall provide a data submission form for the collaborator sites. It is recommended that a trial run be conducted prior to the initiation of the validation study. The purpose of the trial run is to ensure that logistics, test material handling and data reporting processes are worked out and understood by all of the collaborators. A small test material set (2-4 materials) should be analyzed. The trial run should be conducted under the same conditions as the validation study. A period of time should be allotted for troubleshooting after completion of the trial run, including a discussion with each collaborator to address issues and answer questions. The data from this trial run should not be analyzed or included in the validation report. Consider to add that participating labs can/should receive a training by the method developer prior to participation, similar to the qualitative document. The intent of a collaborative study is to establish relevant method attribute estimates that can be expected when a method is used in practice, with a particular focus on precision (repeatability and reproducibility) and recovery. Estimation of sensitivity (LOD and LOQ) is also within the study scope.

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