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FDA clears rapid test for avian influenza A virus
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The FDA has cleared marketing for a rapid test that detects influenza A/H5N1, a strain of avian influenza that can cause the disease in humans.
The test, AVantage A/H5N1 Flu Test (Arbor Vita Corporation), identifies a specific protein (NS1) that indicates the presence of the influenza A/H5N1 virus subtype. The test takes about 40 minutes.
“This test is an important tool to help quickly identify emerging influenza A/H5N1 infections and reduce exposure to large populations,” Daniel G. Schultz, MD, director of the FDA’s Center for Devices and Radiological Health said in a press release. “The clearance of this test represents a major step toward protecting the public from the threat of pandemic flu.”
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.
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 WHO, there have been 412 confirmed human cases of infection from this virus, almost all in Asia and northern Africa.