Laboratory Products
FDA approves swine flu test
May 25 2010
The Emergency Use Authorization, which approves medical products in times of public health emergencies, said that the Simplexa Influenza A H1N1 test can be used to examine signs and symptoms of the virus.
Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said: "With this clearance, the availability of Simplexa H1N1 test will not be affected when the public health emergency expires."
Laboratory scientists created a way to amplify the genome and internal control of the swine flu virus, which can then be detected on nasal swabs and nasal aspirates and now will be able to diagnose patients more accurately.
Recent research by the State University of New York Downstate Medical Center and Kings County Hospital Center in Brooklyn revealed that H1N1 could have serious health risks for pregnant women.
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