BD Diagnostics, a segment of medical technology company BD (Becton, Dickinson and Company) has 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 product is cleared for use in clinical settings.
The new 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 possibly subjective result interpretation of visually read assays and helps deliver an accurate read by providing objective results on a handheld reader with an easy-to-read digital display. Company representatives assert that it has demonstrated proven performance versus polymerase chain reaction (PCR) tests and is the only rapid diagnostic flu test that has been referenced and FDA cleared against this high-sensitivity standard.
The System utilizes Advanced Particle and Adaptive Read Technologies coupled with a special handheld 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 nonspecific binding.
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. Learn more about the BD Veritor System.
