Verification of Performance Specifications of a Molecular Test: Cystic Fibrosis Carrier Testing Using the Luminex Liquid Bead Array

Context.—The number of clinical laboratories introducing various molecular tests to their existing test menu is continuously increasing. Prior to offering a US Food and Drug Administration–approved test, it is necessary that performance characteristics of the test, as claimed by the company, are verified before the assay is implemented in a clinical laboratory. Objective.—To provide an example of the verification of a specific qualitative in vitro diagnostic test: cystic fibrosis carrier testing using the Luminex liquid bead array (Luminex Molecular Diagnostics, Inc, Toronto, Ontario). Design.—The approach used by an individual laboratory for verification of a US Food and Drug Administration–approved assay is described. Results.—Specific verification data are provided to highlight the stepwise verification approach undertaken by a clinical diagnostic laboratory. Conclusions.—Protocols for verification of in vitro diagnostic assays may vary between laboratories. However, all laboratories must verify severa...