BD (Becton, Dickinson and Company) announces that it has received 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver from the Food and Drug Administration (FDA) for the BD Veritor System for rapid detection of Flu A+B. This is the first rapid influenza test system that incorporates a digital read-out of results to receive CLIA waiver.
The BD Veritor System delivers very good analytical sensitivity and specificity, offering healthcare professionals a new and different option in rapid influenza testing versus current visually read CLIA-waived assays. The BD Veritor System provides objective results on an easy to read digital display, unlike current CLIA-waived rapid influenza tests, which require a subjective visual test interpretation to determine a positive or a negative test result.
The new BD Veritor System provides a new approach for CLIA-waived rapid tests for influenza A+B by offering a combination of speed, accuracy and convenience with an objective read that physicians can trust, says Tom Polen, president of BD Diagnostics Diagnostic Systems. We believe the BD Veritor System has the potential to change the way doctors view in-office rapid flu testing.
The BD Veritor System rapid flu immunoassay reports performance measured against polymerase chain reaction (PCR) results, the highest sensitivity standard currently available. This newly designed system incorporates BDs novel Nano Detection Particle and Adaptive Read Technology. With this unique combination of technologies in a CLIA-waived Flu assay, the BD Veritor System offers users a convenient workflow; just a few, easy steps requiring very little sample preparation; no sample incubation required prior to running the test; and a 10-minute period for the test to run and ten seconds of instrument read for final results.
The assay for rapid detection of Flu A+B on the BD Veritor System represents the first of many different assays that are planned on this new platform.
For more information on the BD Veritor System, visit http://www.bd.com/ds/veritorsystem.