FDA clears new influenza test from BD Diagnostics

SPARKS, MD – BD Diagnostics, a segment of medical company Becton, Dickinson and Company, has received 510(k) clearance from the US Food and Drug Administration (FDA) for nasopharyngeal wash, aspirate, and swab in transport media specimens on its BD Veritor System for the rapid detection of influenza A+B.

The new BD Veritor System for Rapid Detection of Flu A+B laboratory kit is designed for testing liquid specimens obtained via nasopharyngeal wash, aspirate, or swab in transport media.

According to a press release by BD Diagnostics, the system eliminates the subjective result interpretation of visually read assays. The system provides objective results on a hand held reader with a digital display and has been demonstrated to be at par with polymerase chain reaction (PCR) tests.

The BD Veritor System utilises Advanced Particle Technology, which helps increase the sensitivity of the test, and Adaptive Read Technology, which helps reduce false-positive results by examining and compensating for many of the effects of non-specific binding, improving specificity.