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FDA Approves Emergency Use Declaration For Multiplex Zika Test

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Food and Drug Administration has issued an Emergency Use Authorization for the first multiplex test for the Zika virus and three other viruses. The FDA made the authorization for the test developed by the Center for Infection and Immunity at Columbia University's Mailman School of Medicine Monday. This test is the first multiplex test that can detect the Zika virus and all serotypes of dengue virus, chikungunya virus and West Nile virus simultaneously. The authorization does not mean that the FDA has cleared or approved the test, but has cleared it for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988. The authorization allows only for the detection of RNA form Zika, dengue, chikungunya and West Nile viruses, not other viruses or pathogens.

Added on the 15/08/2017 10:58:16 - Copyright : Wochit

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