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LabCorp Announces The CDC Zika MAC-ELISA Test Has Received FDA Emergency Use Authorization and Complements the RealStar Zika Virus RT-PCR Kit U.S.

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Additional Relevant Details Laboratory Corporation of America Holdings (LabCorp) today announced the nationwide availability of testing for Zika virus using the Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) developed by the Centers for Disease Control and Prevention (CDC). The test received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), initially onFebruary 26, 2016, and reissued on June 29, 2016, for the qualitative detection of Zika virus IgM antibodies in serum or cerebrospinal fluid (collected alongside a patient-matched serum specimen), and is being made available for the first time to commercial laboratories. It is intended to be used in the diagnosis of Zika virus infection in individuals meeting clinical and/or epidemiological criteria established by CDC for Zika virus infection risk.
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Occurred on:
Aug 02, 2016
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Related Keywords Realstar Zika Virus Rt-pcr Kit, Cdc Zika Mac-elisa Test