BD Diagnostics, a segment of BD (Becton, Dickinson and Company), a leading global medical technology company, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for nasopharyngeal wash, aspirate and swab in transport media specimens on the BD Veritor™ System for Rapid Detection of Flu A+B. This new product is cleared for use in clinical settings.
The new BD Veritor System for Rapid Detection of Flu A+B laboratory kit is specifically configured for testing liquid specimens obtained via nasopharyngeal wash, aspirate or swab in transport media. The system, with proprietary technologies, eliminates the subjective result interpretation of visually read assays and helps deliver an accurate read by providing reliable, objective results on a hand held reader with an easy-to-read digital display. The BD Veritor System for Rapid Detection of Flu A + B has demonstrated proven performance versus polymerase chain reaction tests (PCR). This is the only rapid diagnostic flu test that has been referenced and FDA cleared against this high-sensitivity standard.
"Visually read rapid flu tests have shown variable performance results and are prone to errors when interpreting results," said Tom Polen, President, BD Diagnostics – Diagnostic Systems. "The BD Veritor System provides an advanced rapid diagnostic test for influenza A+B by offering accuracy, consistency, and convenience along with an objective read that laboratorians can trust."
The BD Veritor System utilizes Advanced Particle and Adaptive Read Technologies coupled with a special hand-held reader. The Advanced Particle Technology along with improved chemistries helps increase the sensitivity of the test. The Adaptive Read Technology helps reduce false-positive results by examining and compensating for many of the effects of non-specific binding which improves specificity.
The clinical lab version joins the previously FDA-cleared and CLIA- waived BD Veritor System for Rapid Detection of Flu A+B. This assay for Rapid Detection of Flu A+B on the BD Veritor System represents the first of many planned assays on this new platform.