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Fact sheet for health care providers : interpreting Zika MAC-ELISA results
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  • Description:
    Centers for Disease Control and Prevention Zika MAC-ELISA Emergency Use Authorization The U.S Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to authorize the use of the Centers for Disease Control and Prevention’s (CDC) Zika IgM antibody capture ELISA (Zika MAC-ELISA) for the in vitro qualitative detection of human IgM antibodies to Zika virus. It is intended for use in sera or cerebrospinal fluid (CSF) when submitted with a patient-matched serum sample from individuals meeting CDC Zika clinical and epidemiological criteria for testing in qualified laboratories designated by the CDC. The test is intended for use as part of CDC’s algorithm for Zika testing. FDA issued this EUA based on data submitted by CDC to FDA, and on the U.S. Secretary of Health and Human Services’ (HHS) declaration that circumstances exist to justify the emergency use of in vitro diagnostic tests for the detection of Zika virus and Zika virus infection. This EUA will terminate when the HHS Secretary’s declaration terminates, unless FDA revokes it sooner. The information in this Fact Sheet is to inform you of the significant known and potential risks and benefits of the emergency use of the Zika MAC-ELISA. For more information on this EUA, please see FDA’s website at http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm. zika-mac-elisa-fact-sheet-for-hcp.pdf
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