BD Veritor meets new FDA flu requirements
March 17, 2017—Becton Dickinson announced that its BD Veritor System Flu A+B, a digital immunoassay for the rapid detection of influenza, meets the new FDA performance requirements in which antigen-based rapid influenza virus antigen detection systems (RIDTs) intended to detect influenza virus directly from clinical specimens have been reclassified from class I devices to class II devices subject to special controls.
“The change to the new performance standards may help improve the overall quality of testing for influenza,” Charles Cooper, MD, vice president of medical affairs at BD, said in a statement. “This agency’s decision has the potential to improve patient outcomes— ensuring that the tools health care providers use for diagnosing influenza meet new, higher standards for accuracy. As we know, an accurate diagnosis helps to determine appropriate use of antiviral medications, while at the same time reducing inappropriate over-prescription of antibiotics, which can only help in the fight against antimicrobial resistance.”
The now-class II BD Veritor System Flu A+B test first became available in 2011 and is the same test used on the new BD Veritor Plus System, a next-generation wireless rapid diagnostic system for detection of influenza A and B, respiratory syncytial virus, and group A strep.