FDA has reclassified antigen-based rapid influenza virus antigen detection systems (RIDTs) intended to detect influenza virus directly from clinical specimens from Class I devices into Class II devices subject to special controls.
BD, Franklin Lakes, NJ, has announced that its BD Veritor system Flu A+B, a digital immunoassay for the rapid detection of influenza, meets the new FDA performance requirements.
Prompting these changes was the inadequate performance of some point-of-care flu tests available during the 2009 flu pandemic, which raised concerns regarding the accuracy of RIDTs for detecting influenza in patients. With the new FDA requirements, rapid flu tests, which are used by healthcare providers and laboratory personnel, must now attain a higher level of performance.
“The change to the new performance standards may help improve the overall quality of testing for influenza,” says Charles Cooper, vice president of medical affairs at BD. “This agency’s decision has the potential to improve patient outcomes, ensuring that the tools healthcare 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 overprescription of antibiotics, which can only help in the fight against antimicrobial resistance.”
As part of the new reclassification of rapid flu tests from Class I to Class II, FDA is raising the tests to higher performance standards. The change will help to ensure that healthcare providers and allied health professionals who use rapid flu tests to detect influenza viruses will have quick access to more accurate information.
In recognizing the need to improve diagnostics, BD developed and launched the BD Veritor system for rapid detection of flu A and B. This was the first Clinical Laboratory Improvement Amendments (CLIA)-waived flu test that provides objective results on an easy-to-read digital display. The now Class II BD Veritor system Flu A+B test 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, group A Strep, and respiratory syncytial virus.
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