General Principles of Validating a Molecular Test

Abstract

Before a molecular test is implemented for reporting patient results, it is the responsibility of the laboratory to validate or verify, as well as to document, the performance characteristics of the assay. Such performance characteristics relate to the accuracy, precision, and robustness of the test in measuring the analyte for the intended purposes of the test. Assay validation is an extensive process that has to conform to the standards, as determined by regulations such as the ones passed by the US Congress in 1988: the Clinical Laboratory Improvement Amendments (CLIA-’88). The standards implemented by CLIA-’88 were designed to ensure the accuracy and reliability of human patient testing results regardless of where the test was performed. CLIA-’88 regulations established different complexity levels of laboratory tests. As such, laboratory testing is divided into simple or “waived” tests, tests of moderate complexity, and high complexity tests. All molecular tests fall within the “high-complexity” category as defined by CLIA-’88 [1].