FDA reclassifies rapid-flu detection standards

The U.S. Food and Drug Administration recently reclassified rapid-flu detection devices from Class I to Class II.
The antigen-based rapid influenza antigen detection systems that are meant to detect the virus from clinical specimens now are subject to special controls, according to PRNewswire. 
The reclassification was due to inadequacies in a portion of point-of-care flu tests that were available during the 2009 flu season. The lapse in quality of care was a concern in regard to the ability to detect the flu in patients. With new FDA requirements for flu testing, rapid flu tests are expected to perform better.
BD Company's Veritor System Flu A+B, which is a digital immunoassay for rapid flu detection, has been cleared by the FDA. 
"The change to the new performances standards may help improve the overall quality of testing for influenza," BD Company Vice President of Medical Affairs Dr. Charles Cooper said. 
The FDA's hopes for the heightened standards are that health professionals who use the rapid testing approach will have accurate results in a more timely manner.