FDA approves new CDC test for influenza

October 2, 2008

The US Food and Drug Administration (FDA) approved a test developed by the Centers for Disease Control and Prevention (CDC) used to diagnose influenza, including the H5N1 flu virus.

The US Food and Drug Administration (FDA) approved a test developed by the Centers for Disease Control and Prevention (CDC) used to diagnose influenza, including the H5N1 flu virus.

The test, called the Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel), can detect commonly circulating human influenza viruses, with results available within four hours.

The rRT-PCR Flu Panel can differentiate between seasonal and novel influenza. Viral genetic material taken from a patient's nose and throat using the device is then analyzed by a diagnostic instrument called the Applied Biosystems 7500 Fast Dx, which the FDA has also approved for use.

The rRT-PCR Flu Panel is meant to help enable the accuracy of influenza testing results among CDC-qualified laboratories, and will be available beginning this fall.