A test for the 2009 H1N1 influenza A virus that has been available under an emergency use provision since last summer has been cleared for use by the Food and Drug Administration, the agency announced.
This test was made available in July 2009 through an Emergency Use Authorization (EUA), which allows the FDA to authorize the use of unapproved medical products when a public health emergency has been declared. The first wave of the 2009 influenza virus A outbreaks in the spring of 2009 was the basis of the public health emergency declared in April 2009, and tests for the virus were subsequently made available under the EUA.
The test cleared by the FDA is the Simplexa Influenza A H1N1 (2009), which is manufactured by Focus Diagnostics Inc. This was the first test to be made available commercially through the EUA, according to a statement from the company.
“With this clearance, the availability of Simplexa H1N1 test will not be affected when the public health emergency expires,” Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in the FDA statement announcing clearance of the test.
The test uses specimens from nasal swabs or aspirates; a positive test indicates infection with the 2009 H1N1 influenza virus, but a negative test result “does not preclude influenza virus infection,” according to the FDA statement.
The FDA's information on 2009 H1N1 influenza is available at www.fda.gov/NewsEvents/PublicHealthFocus/ucm150305.htm#tests