FDA Okays Rapid Test for Four Common Respiratory Viruses

By Peggy Peck
ROCKVILLE, Md., Jan. 18 -- A real-time test that can identify four common respiratory viruses -- including seasonal flu -- has been cleared for marketing by the FDA.
The ProFlu+ test provides results in about three hours, well within the two-day window when antiviral therapy is most effective, said Daniel Shultz, M.D., director of the FDA's center for devices and radiological health.
The test employs a multiplex platform that allows several tests to be processed using the same sample to detect influenza A virus, influenza B virus, and respiratory syncytial virus A and B (RSV) -- a quartet of viruses that are among the leading causes of lower respiratory tract infections.
ProFlu+ uses a molecular biology process to isolate and amplify viral genetic material present in secretions taken from the back of the throat in patients.
The FDA said the new test is not only faster, but also more accurate than existing assays when used with other diagnostic information such as patient data, bacterial or viral cultures, and X-rays.
However, the agency noted, positive results do not rule out other infection or co-infection and the virus detected may not be the specific cause of the disease or patient symptoms.
ProFlu+ is manufactured by Prodesse, Inc., of Milwaukee