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BD Receives FDA Clearance for Veritor Rapid Flu Detection System

December 20th, 2011 Jan Sinnige Diagnostics, Pathology

BD, Franklin Lakes, NJ, received FDA clearance for their new Veritor System, a device for rapid detection of influenza A and B. The system runs a chromatographic immunoassay for direct detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs. Viral antigens from influenza A can be distinguished from influenza B in a single processed sample. This allows a rapid choice in selective antiviral intervention or appropriate preventative measures for institutions.

The system can deliver digital results in about 10 minutes on a large display which reduces the subjective interpretation of the earlier visual test results.

The device works with a CLIA-waived kit configured for testing nasal and nasopharyngeal swab samples. Although the test is not intended to detect influenza C antigens, BD is planning to run many more assays on this new platform in the near future.

Press release: New BD Veritor™ System for Rapid Detection of Flu A+B Receives 510(k) Clearance and CLIA Waiver…

Product page: BD Veritor…

Jan Sinnige

Clinical Microbiologist, MD at Red Cross Burn Center Beverwijk, The Netherlands. PhD Candidate in molecular epidemiology of Vancomycin Resistant Enterococcus faecium (VRE). Living in Amsterdam.

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