A new, quicker bird flu test for humans has been approved by the U.S. Food and Drug Administration.
The test detects influenza A/H5N1 in throat or nose swabs collected from patients with flu-like symptoms. In less than 40 minutes, the test identifies a specific protein (NS1) that indicates the presence of the influenza A/H5N1 virus subtype. Previously FDA-approved tests took three to four hours to identify this virus subtype.
The new test, called the AVantage A/H5N1 Flu Test, is made by Arbor Vita Corp., in Sunnyvale, Calif. In clinical studies, the test correctly identified the absence of infection in more than 700 specimens. It also correctly detected the presence of influenza A/H5N1 virus subtype in 24 cultured specimens from infected patients, the FDA said Tuesday.
"This test is an important tool to help quickly identify emerging influenza A/H5N1 infections and reduce exposure to large populations," Dr. Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health, said in an agency news release. "The clearance of this test represents a major step toward protecting the public from the threat of pandemic flu."