New Influenza Test Cleared for Nasopharyngeal Specimens in Transport Media

The US Food and Drug Administration (FDA) has now cleared for use in clinical laboratories a Flu A+B rapid detection kit specifically configured for testing liquid specimens obtained via nasopharyngeal wash, aspirate, or swab in transport media.

FDA 510(k) clearance was given for the “BD Veritor System for Rapid Detection of Flu A+B” developed by BD Diagnostics, a segment of the global medical technology company Becton, Dickinson and Company (BD; Franklin Lakes, NJ, USA). The new system offers advanced, reliable performance: with proprietary technologies it 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. This BD test demonstrated high performance versus polymerase chain reaction (PCR) tests. This is the only rapid diagnostic flu test that has been referenced and FDA cleared against the PCR high-sensitivity standard. “Visually read rapid flu tests have shown variable performance results and are prone to errors when interpreting results. 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,” said Tom Polen, president, BD Diagnostics – Diagnostic Systems.

The BD Veritor System utilizes Advanced Particle and Adaptive Read Technologies coupled with the 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 nonspecific binding, thereby improving specificity.

This 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.

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Becton, Dickinson and Company
BD Veritor System