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FDA Clears New CDC Test to Detect Human Influenza

Oct 06, 2008

The U.S. Food and Drug Administration (FDA) cleared a new test developed by the U.S. Centers for Disease Control and Prevention (CDC) to diagnose human influenza infections.

The U.S. Food and Drug Administration (FDA) cleared a new test developed by the U.S. Centers for Disease Control and Prevention (CDC) to diagnose human influenza infections and the highly pathogenic influenza A (H5N1) viruses. The device, called the Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel), uses a molecular biology technique to detect flu virus and differentiate between seasonal and novel influenza. The device is used to isolate and amplify viral genetic material present in secretions taken from a patient’s nose or throat. The viral genetic material is labeled with fluorescent molecules, which are then detected and analyzed by a diagnostic instrument called the Applied Biosystems 7500 Fast Dx, also cleared today by the FDA for diagnostic use simultaneously with the CDC’s rRT-PCR Flu Panel. The test panel and diagnostic system can detect and identify commonly circulating human influenza viruses as well as influenza A (H5N1) viruses. Results can be available within four hours and the system can test multiple samples at once. For more information, visit  "http://www.pandemicflu.gov".