The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for a yet to be approved 2009 H1N1 influenza virus test for troops based overseas.
The EUA, which authorises the use of unapproved medical products, will allow the US Department of Defense to distribute the H1N1 test to qualified military laboratories to perform the tests and also analyse the results.
The test to be used is the CDC swH1N1 (swine) Influenza Real-Time RT-PCR, developed by the US Centres for Disease Control and Prevention.
FDA Commissioner of Food and Drugs Margaret Hamburg said that the FDA had worked quickly with the Defense Department to authorise the use of this test.
“The test will aid in more rapid diagnosis of 2009 H1N1 influenza infections so that deployed troops can quickly begin appropriate medical treatment,” said Hamburg.
The tests will be administered throughout the military by the US Defense Department’s Joint Biological Agent Identification and Diagnostic System.