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 several specific performance specifications prior to implementation of such assays for clinical use. We provide an example of an approach used for verifying performance of an assay for cystic fibrosis carrier screening.