The US Food and Drug Administration has cleared for marketing a new, 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 3-4 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.”
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.