Skip to main content
Premium Trial:

Request an Annual Quote

BD Digital Immunoassay Meets New FDA Flu Requirements

NEW YORK (360Dx) – Becton Dickinson said today that its digital immunoassay, the BD Veritor System Flu A+B, meets new US Food and Drug Administration performance requirements for influenza virus antigen detection test systems.

"The change to the new performance standards may help improve the overall quality of testing for influenza," Charles Cooper, vice president of medical affairs at BD, said in a statement. The FDA's decision may improve patient outcomes because healthcare providers will use tools for diagnosing influenza that meet higher standards for accuracy, he said.

An accurate diagnosis helps to determine appropriate use of antiviral medications, while at the same time reducing inappropriate over-prescription of antibiotics, he added.

Healthcare providers and allied health professionals who use rapid flu tests to detect influenza viruses will have quick access to more accurate information, BD said.

Effective last week, the FDA had reclassified rapid influenza virus antigen detection systems (RIDTs) from Class 1 to Class II devices subject to special controls.

Prompting these changes was the inadequate performance of some point-of-care flu tests during the 2009 flu pandemic, which raised concerns about the accuracy of detecting influenza in patients, BD said. The new FDA classification means rapid flu tests must adhere to a higher level of performance, the firm added.

BD noted that its BD Veritor System for Rapid Detection of Flu A+B was the first Clinical Laboratory Improvement Amendments-waived flu test that provides objective results on an easy-to-read digital display. BD said that its test, made available in 2011, is also used on the firm's 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.