FDA clears for marketing new, more rapid test for the detection of influenza A/H5N1

The U.S. Food and Drug Administration “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. Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health, commented, “This test is an important tool to help quickly identify emerging influenza A/H5N1 infections and reduce exposure to large populations,” said. “The clearance of this test represents a major step toward protecting the public from the threat of pandemic flu.” AVantage A/H5N1 Flu Test is manufactured by Arbor Vita Corporation, located in Sunnyvale, California

http://www.fda.gov/bbs/topics/NEWS/2009/NEW01987.html

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