Test Validation

As with any other area of the clinical laboratory, the introduction of a new test requires proper validation. There are major differences between the implementation of a FDA-approved test compared to one that is not. CLIA'88 provides specific provisions for validation of these assays. Laboratories implementing FDA-approved tests need to verify and document the performance characteristics of the test for the indications for use in populations similar to those in which the manufacturer has established performance. On the other hand, implementation of in-house-developed assays requires a more involved process with extensive documentation on test performance, in addition to quality control programs to assure daily performance of the test. Table 2 provides a list of guidelines and standards for molecular diagnostics testing that can be used as a reference during assay development and verification. In addition, Table 3 describes the different aspects of documentation that would be useful to capture during this process.

Verification of a LDA is a complex process that can be divided in two phases: analytical and clinical verification. These parameters provide information about the analytical performance of the test. The other phase of the verification process is the clinical verification. This phase provides information about the clinical utility of the test with regard to the intended use. Determination of the intended use provides information about the appropriate settings, including disease states and populations for which the test can be useful. It is important to point out that "intended use" refers to the DNA or RNA that a molecular assay detects or quantifies, whereas "indications for use" refers to the clinical syndrome/condition for which the assay can be used for diagnosis, management or monitoring of disease.

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