FDA Clears New CDC Test to Detect Human Influenza

October 8, 2008

A new test developed by the US Centers for Disease Control and Prevention (CDC) to diagnose human influenza infections and the highly pathogenic influenza A (H5N1) viruses has been cleared by the FDA.

A new test developed by the US Centers for Disease Control and Prevention (CDC) to diagnose human influenza infections and the highly pathogenic influenza A (H5N1) viruses has been cleared by the FDA.

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 the 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.

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.

The test will be available to CDC-qualified laboratories for diagnosing influenza this fall, and some laboratories will be able to obtain reagents (certain substances used in the testing process) at no cost. This test should help ensure the accuracy of influenza testing results among the different qualified laboratories that conduct influenza subtype testing.