BD supports proposal by FDA to reclassify rapid flu tests
The 2009 flu pandemic demonstrated the poor performance of available point-of-care flu tests. The FDA's proposal would increase performance requirements for RIDTs to have a sensitivity of 90 percent for influenza A and 80 percent for influenza B. If certain devices fail to meet the minimum clinical performance criteria, the devices would need to be withdrawn from the market one year after the rule is finalized.
"This proposal is a step in the right direction as physicians and hospitals routinely rely on rapid diagnostic influenza tests to help manage patients that are suspected of having influenza," Tom Polen, the president of BD Diagnostics - Diagnostic Systems, said. "Raising the standards of rapid influenza tests will provide healthcare providers the right information to guide patient diagnosis and treatment without requiring repeat testing."
The proposal comes after years of publications demonstrating that many visual read RIDTs had poor sensitivity when compared to reverse transcription polymerase chain reaction and viral culture methods.
On June 13, the FDA's Center for for Devices and Radiological Health Microbiology Devices Advisory Committee met to examine the FDA's proposal. The proposal would reclassify RIDTs from Class I devices into Class II devices.
BD developed the BD Veritor System Flu A+B Test two years ago to serve as an improved early test providing objective results on an easy-to-read digital display.