FDA clears rapid test for the detection of influenza A/H5N1

The U.S. Food and Drug Administration today cleared for marketing a new, more rapid test for the detection of influenza A/H5N1, a disease-causing subtype of the avian influenza A virus that can infect humans.

The test, called AVantage A/H5N1 Flu Test, detects influenza A/H5N1 in throat or nose swabs collected from patients who have flu-like symptoms. The test identifies in less than 40 minutes a specific protein (NS1) that indicates the presence of the influenza A/H5N1 virus subtype. Previous tests cleared by the FDA to detect this influenza A virus subtype can take three or four hours to produce results.

“This test is an important tool to help quickly identify emerging influenza A/H5N1 infections and reduce exposure to large populations,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health. “The clearance of this test represents a major step toward protecting the public from the threat of pandemic flu.”

Influenza A infects both humans and animals. H5N1 is a subtype that is found mostly in birds, although infections have also occurred in humans, mostly in people who have come into contact with the virus through infected poultry. According to the Centers for Disease Control and Prevention, of the few avian influenza viruses that have infected humans, the H5N1 subtype has caused the largest number of detected cases of serious disease and death.

There is a possibility that the influenza A/H5N1 virus subtype could mutate further and spread quickly to humans, causing an influenza pandemic. According to the World Health Organization, there are 412 confirmed human cases of infection from this virus, almost all in Asia and northern Africa. This virus subtype, which can cause life-threatening illness, has not been detected in the Americas.

In clinical studies, the test correctly identified the absence of infection in more than 700 specimens. In addition, the test correctly detected the presence of influenza A/H5N1 virus subtype in 24 cultured specimens from infected patients.

AVantage A/H5N1 Flu Test is manufactured by Arbor Vita Corporation, located in Sunnyvale, Calif.