From Our 2010 Archives
Simplexa H1N1 Test Approved
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MONDAY, May 24 (HealthDay News) -- The Simplexa diagnostic test to detect infection with the H1N1 "swine" flu virus has been approved by the U.S. Food and Drug Administration, the agency said Monday in a news release.
Prior to the approval, the test was available under the agency's Emergency Use Authorization, which allows the FDA to sanction use of unapproved medical products during a public health emergency. The agency declared such an emergency on April 26, 2009, and the new approval permits the test's continued use after the emergency declaration expires.
The test uses nasal specimens to detect the presence of the H1N1 virus, although it does not indicate the infection's severity.
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