Wednesday, May 26, 2010

FDA Clears H1N1 Test for General Use

WASHINGTON -- A test for the pandemic H1N1 influenza has been formally approved for use outside a public health emergency situation, the FDA announced.

Until the clearance of Simplexa Influenza A H1N1 (2009), which is used to test for the pandemic virus in patients with signs and symptoms of respiratory infection, tests for the new virus were available only through an Emergency Use Authorization (EUA).

Such use was allowed after the Department of Health and Human Services declared a public health emergency related to the new H1N1 virus on April 26, 2009. All EUAs expire when the emergency for which they are issued is considered over.

"With this clearance, the availability of the Simplexa H1N1 test will not be affected when the public health emergency expires," said Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, in the agency's announcement.

Although a positive result on the test, which uses specimens from nasal swabs or nasal aspirates, indicates infection with H1N1 flu, a negative result does not rule out infection.

The Simplexa test is made by Focus Diagnostics.


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