Verification and Validation of Tests Used in the Clinical Microbiology Laboratory

Abstract

Test verification and validation are two very important, College of American Pathologists (CAP)-required processes used in the laboratory to ensure that a new test performs as expected and continues to perform as expected throughout its use. The initial analysis of test performance is achieved by performing test verification, which is a one-time process to confirm the expected test performance characteristics provided by the manufacturer. The type and depth of the verification are dependent upon the type of test being verified and can range from a rather simple comparison to a much more complex analysis. Conversely, test validation, is an ongoing process to monitor and ensure that the test continues to perform as expected and is typically achieved though the laboratory's quality assurance plan. Designing appropriate test verification and validation plans can be confusing; therefore, the purpose of this paper is to clarify the various processes and procedures that can be used.