FDA OKs H1N1 Influenza Virus Test

WASHINGTON, May 24 (UPI) — The U.S. Food and Drug Administration announced approval Monday of the Simplexa Influenza A H1N1 (2009) virus test.

Until Monday’s clearance, tests for 2009 H1N1 virus were only available through an Emergency Use Authorization, which allows the FDA to authorize the use of unapproved or uncleared medical products during the time a declaration of emergency is in effect.


On April 26, 2009, the U.S. Department of Health and Human Services declared a public health emergency due to the 2009 H1N1 Influenza Virus.

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

Using specimens from nasal swabs or nasal aspirates, the Simplexa Influenza A H1N1 test simultaneously amplifies and detects two regions of the influenza virus genome and an internal control in patients showing signs and symptoms of respiratory infection, the FDA said. A positive result indicates a patient is infected with the virus, but the test does not indicate the stage of infection. A negative result does not preclude influenza virus infection.

The test is manufactured by Focus Diagnostics Inc. of Cypress, Calif.

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