FDA Clears Lab Test for Bird Flu Infections in Humans

FDA Clears Lab Test for Bird Flu Infections in Humans

The Food & Drug Administration this month approved a new laboratory test to diagnose the H5 strain of the Avian Influenza virus (a.k.a. bird flu) in people. The test, which was developed by the Centers for Disease Control & Prevention, is called the Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe Set. It provides results within four hours vs. 2-3 days for previous culture-based methods. If the test detects the H5 strain, further tests must be run to see if the N1 subtype is involved.

The CDC will distribute kits for the new test to all 50 states. The kits will go to labs in the Laboratory Response Network, totaling about 140 labs nationwide. The test has also been shared with the World Health Organization and its collaborating centers worldwide. Results of the test will be used to track cases of illness with the H5 strain. The test is used in patients with symptoms of severe respiratory illness and a risk of exposure, such as direct contact with sick, dead, or infected poultry in a country with outbreaks of the H5N1 virus in poultry.

Since December 2003, more than 160 human cases of bird flu caused by the H5N1 strain have been reported in Thailand, China, Vietnam, Cambodia, Indonesia, Turkey, and Iraq. More than half of those infected have died.