Alternative Approaches for Qualitative Microbiological Method Matrix Additions

Most commonly used pathogen detection methods have undergone a rigorous validation through third-party certification bodies such as AOAC INTERNATIONAL, Association Française de Normalisation, MicroVal, and others. These validations focus on sensitivity, robustness, and inclusivity and exclusivity of the assay target(s) for the matrices submitted to the certification body. This creates a list of officially validated matrices that falls far short of what is seen routinely during end-user testing. Thorough validation of all matrices at all test portion sizes is neither cost efficient, practical, nor arguably necessary. Here, we provide guidance on alternate evaluation approaches using a food-similarity grouping and a risk-based questionnaire to help end-users determine an appropriate level of evaluation of their method of choice. In reducing the burden of evaluation for many matrices, these alternative approaches may allow more matrices to be evaluated, thus strengthening confidence in method application and ultimately leading to a safer food supply.