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".