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FDA approves emergency use of H1N1 test for U.S. troops serving overseas
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The FDA has issued an Emergency Use Authorization to allow a 2009 H1N1 influenza virus test to be used to detect the virus in military personnel serving overseas. The test was developed by CDC and is called the CDC swH1N1 (swine) Influenza Real-Time RT-PCR.
The Emergency Use Authorization allows for the use of unapproved medical products or unapproved uses of medical products during times of public health emergency.
Under the terms of the authorization, the U.S. Department of Defense will be permitted to distribute the test to laboratories that meet equipment and personnel training requirements necessary to perform the test and interpret the results.
The terms also stipulate that the Joint Biological Agent Identification and Diagnostic System of the Defense Department will be used to run the test. As early as 2005, assays similar to the current H1N1 product have been approved by the FDA for utilization by this arm of the Defense Department.