Verification of CLSI MM17-A Multiplex Nucleic Acid Tests

This standard provides recommendations for qualitative multiplex nucleic acid test validation. This guide focuses primarily on analytical validation, analytical validation, and QC and briefly discusses the establishment of clinical validation and clinical validation for these tests. The target audience includes lab managers, medical microbiologists, lab technologists, QA staff, and assay manufacturers. This guide is not intended to be regulatory guidance, but is intended to provide current best practice recommendations.

The design, acquisition and appropriate use of different control materials are thoroughly reviewed. Valid test formats are used to demonstrate appropriate validation and validation protocols, and appropriate data analysis and result reporting for multiplex tests are described. Because traditional single-measure protocols are difficult or impossible to perform with multiplex assays, an error-based approach to validation and validation is presented. This error-based approach can be applied to multiplex experiments with a single test method where performance characteristics for different measurands are expected to be similar.

This standard discusses multiplex assays for genotyping and pathogen detection and excludes gene expression experiments. This guide also does not cover tests that measure individual goals that are evaluated together to ultimately obtain a composite score or classifier.

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