Verification of performance specifications of a molecular test: cystic fibrosis carrier testing using the Luminex liquid bead array.
BACKGROUND
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).


METHODS
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.
Department of Pathology, State University of New York Downstate Medical Center, Brooklyn, 11203, USA. felicitas.lacbawan@downstate.edu
Felicitas L
FL
Lacbawan
Karen E
KE
Weck
Jeffrey A
JA
Kant
Gerald L
GL
Feldman
Iris
I
Schrijver
D003550:Cystic Fibrosis / Q000175:diagnosis* / Q000235:genetics*; D019005:Cystic Fibrosis Transmembrane Conductance Regulator / Q000235:genetics; D005820:Genetic Testing / Q000295:instrumentation* / Q000379:methods*; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000592:standards*; D009154:Mutation / Q000235:genetics; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014481:United States; D014486:United States Food and Drug Administration
D019005:Cystic Fibrosis Transmembrane Conductance Regulator