The Food and Drug Administration approved a new test that can diagnose human influenza infections, including the highly pathogenic influenza A (H5N1) virus, and produce results within 4 hours.
The device, known as the Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel), was developed by the Centers for Disease Control and Prevention. It is able to detect and identify the most commonly circulating human influenza viruses using a molecular biology technique that can “differentiate between seasonal and novel influenza,” according to a written statement released jointly by the FDA and CDC.
The ability to distinguish those differences facilitates speedier diagnoses, Dr. Frank Torti, FDA principal deputy commissioner and chief scientist, said in the statement.
“It will also provide qualified laboratories with a means to rapidly detect new influenza viruses that have not been identified yet and that could pose a pandemic risk,” Dr. Torti commented.
Dr. Julie Gerberding, director of the CDC, emphasized the value of having a tool that can test multiple samples at the same time and produce results faster.
Representatives of the FDA and the CDC said the device isolates and amplifies viral genetic material present in secretions taken from a patient's nose or throat. That material is analyzed by another device, called the Applied Biosystems 7500 Fast Dx, which was approved simultaneously with the rRT-PCR Flu Panel.
The test will be available to CDC-qualified laboratories as soon as the end of this year. Some labs will be eligible to receive reagents free of charge to aid in the testing process.
The CDC, Applied Biosystems Inc., and the Association of Public Health Laboratories collaborated on the development of the new test.
The H5N1 virus is of particular concern to researchers because it can circulate widely among people, raising the threat of a pandemic.
According to World Health Organization data, there have been 387 cases and 245 deaths from the virus worldwide since 2003.