FDA Approves Rapid Test for H5N1 Virus in Humans

US - The US Food and Drug Administration (FDA) yesterday cleared for marketing a new, more rapid test for the detection of H5N1 virus, a disease-causing subtype of the bird flu virus that can infect humans.
calendar icon 8 April 2009
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The test, called A Vantage A/H5N1 Flu Test, detects 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 H5N1 virus. Previous tests cleared by the FDA to detect the virus can take three or four hours to produce results.

"This test is an important tool to help quickly identify emerging H5N1 infections and reduce exposure to large populations," said Daniel G. Schultz, 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."

H5N1 virus 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 US 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 H5N1 virus subtype could mutate further and spread quickly to humans, causing an influenza pandemic. According to the World Health Organization, there are 413 confirmed human cases of infection from H5N1.

Almost all the cases were found in Asia and northern Africa, but 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 H5N1 virus subtype in 24 cultured specimens from infected patients.

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

Further Reading

- You can visit the Avian Flu page by clicking here.
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