FDA: New Test Approved for Detecting Influenza Viruses
Test rapidly diagnoses seasonal influenza infections as well as possibly pandemic viruses
WEDNESDAY, Oct. 1 (HealthDay News) -- The Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel) -- a new test developed by the U.S. Centers for Disease Control and Prevention -- received approval Sept. 30 from the U.S. Food and Drug Administration for the diagnosis of seasonal human influenza infections as well as influenza A (H5N1).
Using secretions taken from a patient's nose or throat, the rRT-PCR Flu Panel amplifies viral genetic material and labels it with fluorescent molecules that are analyzed by Applied Biosystems 7500 Fast Dx, a diagnostic instrument also approved Sept. 30 by the FDA. Results are available within four hours.
The FDA approval is based on clinical evaluations performed at state public health laboratories in Virginia, Iowa, California, Massachusetts, Wisconsin and Washington. Developed in collaboration with Applied Biosystems of Foster City, Calif., and the Association of Public Health Laboratories, the new test will be available this fall to CDC-qualified laboratories.
"The application of the test to detect an emergent influenza virus would be especially important in the early stages of a pandemic," U.S. Department of Health and Human Services Secretary Mike Leavitt said in a statement. "This breakthrough allows for a more timely detection of a pandemic virus, which helps in determining when to begin broad control strategies as well as life-saving mitigation measures, such as closing schools, canceling social gatherings and informing businesses to begin work-at-home policies."