9/5/2023 0 Comments Pathology testThe CAP Molecular Pathology Checklist also provides some guidance on test validation. In addition to CLSI, other organizations such as the Centers for Disease Control and Prevention and the American College of Medical Genetics have published recommendations on approaches to validation for certain types of molecular pathology testing. Organizations such as the Clinical and Laboratory Standards Institute (CLSI) provide excellent guidance on how to approach test verification and validation for a wide variety of test types. For this reason, the meaning and relevance of some performance characteristics, such as reportable range, reference range, and analytic specificity for molecular diagnostic tests, is still being discussed and refined. CLIA '67 was revised and expanded in 1988, well before genetic testing became widely used. The scientific approach used to verify or validate the performance characteristics of a test is one of the more challenging aspects of being a laboratory director. While a laboratory must, at a minimum, address all the performance characteristics required by CLIA, the specifics of how to verify or establish these is left by CLIA to the judgment of the laboratory director. It should be noted that the term validation is widely used by laboratorians to mean establishing the performance characteristics of an LDT, but the term validation never appears anywhere within the CLIA regulations. A laboratory must document that it has adequately verified or validated test performance characteristics for all clinically offered tests. Verification of FDA-cleared/approved tests generally entails smaller studies with fewer samples than are required to validate an LDT or a modified FDA-cleared/approved test because the manufacturer has already established the performance characteristics of the FDA-cleared/approved tests. In addition, these examples may provide experienced molecular laboratories with alternative approaches for improvement of their current validation and verification procedures.ĬLIA requires that laboratories performing LDTs, and modified FDA-cleared/approved tests, “establish” the same 4 performance characteristics that are required for FDA-cleared/approved tests, as well as determine analytic sensitivity, analytic specificity, and any additional performance characteristics that may be important to establish (eg, specimen stability, linearity). However, we believe presenting specific examples of approaches of validation or verification of new molecular assays will be very useful for laboratories initially introducing molecular diagnostic assays. They are not meant to imply that they are the best or only approach for establishing performance characteristics, or that they are endorsed guidelines. These articles are examples of approaches taken by individual laboratories for verification or validation of molecular assays. In the present issue of the A rchives, 4 CAP resource committees involved in molecular diagnostics present specific examples of approaches used by individual laboratories in introducing molecular tests into the clinical laboratory. In 2009, Jennings et al and the College of American Pathologists (CAP) Molecular Pathology Resource Committee 1 published a detailed article in Archives of Pathology & Laboratory Medicine describing the established principles of test validation and relevant regulations in the United States as they pertain to molecular diagnostic assays. Many laboratories, especially those introducing new types of molecular assays, would welcome additional guidance, especially in the form of specific examples, on the process of preparing a new molecular assay for clinical use. Although guidelines exist for how validation and verification studies may be addressed for molecular assays, the specific details of the approach used by individual laboratories is rarely published. Before introducing any new test into the clinical laboratory, the performance characteristics of the assay must be “verified,” if it is a US Food and Drug Administration (FDA)–approved or FDA-cleared test, or “validated,” if it is a laboratory-developed test. With our ever-increasing understanding of the molecular basis of disease, clinical laboratories are implementing a variety of molecular diagnostic tests to aid in the diagnosis of hereditary disorders, detection and monitoring of cancer, determination of prognosis and guidance for cancer therapy, and detection and monitoring of infectious diseases.
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