Test Validation

Abstract

Assay validation/verification is a central activity of all clinical laboratories but commands particular emphasis in molecular pathology because of the recent growth and evolution of this discipline within the clinical laboratory and the rapid expansion of the application of molecular testing to patient care and management. Moreover, this area of laboratory medicine relies heavily on the development of in-house methods, which demand additional thoroughness and experimental rigor in their design and evaluation. The intent of this chapter is to provide an overview of the federal requirements that govern laboratory testing validation and verification and to provide general guidance for laboratory directors and technologists in planning a comprehensive step-by-step validation/verification procedure. However, because of the novel nature of molecular diagnostics, its diverse technologies and applications, and the variations found in regulations/guidelines from accrediting agencies, no single protocol can adequately address the full validation/verification process for each molecular test. Therefore, this chapter must be considered only as a general guide for those wishing to evaluate the performance characteristics of a new molecular test or testing platform in the clinical laboratory.