Waiver granted for rapid flu test system

January 1, 2012

The first rapid influenza testing system that provides a digital readout of test results for 7 strains of influenza A and B has been given 501(k) clearance and a Clinical Laboratory Improvement Amendments waiver by the US Food and Drug Administration.

The first rapid influenza testing system that provides a digital readout of test results for 7 strains of influenza A and B has been given 501(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver by the US Food and Drug Administration.

BD Veritor System for Rapid Detection of Flu A+B (Becton Dickinson; La Jolla, California) is a rapid chromatographic immunoassay that detects and differentiates 4 influenza A and 3 influenza B viral nucleoprotein antigens from a single nasopharyngeal or nasal swab of symptomatic patients.

When the specimen is added to the test device, viral antigens bind to anti-influenza antibodies conjugated to detector particles on the A+B test strip and migrate to the reaction area where the conjugate is captured by an antibody line on the membrane. An electronic reader interprets the presence or absence of the target analyte and displays the results on a liquid crystal display. No specimen incubation time is needed before running the test, which takes about 10 minutes.