The US Food and Drug Administration (FDA) has issued an emergency use authorisation (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 tests and also analyse the results.
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The test to be used is the CDC H1N1 (swine) influenza real-time RT-PCR, developed by the US Centre 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 H1N1 influenza infections so that deployed troops can quickly begin appropriate medical treatment,” Hamburg said.
The tests will be administered to the military by the US Defense Department’s joint biological agent identification and diagnostic system.
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By GlobalData
