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FDA approves influenza A (H1N1) test for general use
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The FDA has approved the Simplexa Influenza A H1N1 (2009) assay from Focus Diagnostics for use in patients with signs and symptoms of respiratory infection.
Before this approval, tests for 2009 influenza A (H1N1) were only cleared through an Emergency Use Authorization, which allows the FDA to authorize use of unapproved products or uses of products during times of emergency. Emergency Use Authorizations are based on available data.
The assay uses specimens from nasal swabs or nasal aspirates and detects two regions of the influenza virus and an internal control. A positive test indicates influenza A (H1N1) infection but does not indicate the stage of infection. A negative result does not preclude infection, according to an FDA press release.
“With this clearance, the availability of Simplexa H1N1 test will not be affected when the public health emergency expires,” Jeffrey Shuren, MD, JD,director of the FDA’s Center for Devices and Radiological Health, said in a press release.
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