FDA clears H1N1 test

A test for the 2009 H1N1 Influenza Virus in patients displaying signs and symptoms of respiratory infection has been cleared by the U.S. Food and Drug Administration.

Prior to the clearance of Simplexa Influenza A H1N1 (2009), tests were only available through an Emergency Use Authorization. This EUA allows the FDA to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products based on the evaluation of available data during a declaration of emergency.

A public health emergency was declared by the U.S. Department of Health and Human Services on April 26, 2009, as a result of the 2009 H1N1 Influenza Virus.

“With this clearance, the availability of Simplexa H1N1 test will not be affected when the public health emergency expires,” Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said.

The Simplexa Influenza A H1N1 (2009) test uses specimens from nasal swabs or nasal aspirates to simultaneously amplify and detect two regions of the influenza virus genome and an internal control.

Positive test results indicate that a patient has been infected with the 2009 H1N1 influenza virus, though the test does not indicate the state of the infection. A negative test, however, does not preclude influenza virus infection.

Focus Diagnostics, Inc., based in Cypress, California, manufactures the Simplexa Influenza A H1N1 (2009) test.