Fact sheet for healthcare providers : interpreting Zika MAC-ELISA test results
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Fact sheet for healthcare providers : interpreting Zika MAC-ELISA test results

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    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 (CDC) Zika IgM antibody capture enzyme-linked immunosorbent assay (Zika MAC-ELISA). This assay provides in vitro qualitative detection of human IgM antibodies to Zika virus. The Zika MAC-ELISA is intended for use in serum of individuals meeting CDC Zika clinical and/or epidemiological criteria for testing in qualified laboratories designated by the CDC (see http://www.cdc.gov/zika/hc-providers/index.html). It can also be used in cerebrospinal fluid (CSF) when submitted with a patient-matched serum sample. This test should be performed according to CDC’s algorithm for Zika testing (see http://www.cdc.gov/zika/laboratories/lab-guidance.html).

    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 (see http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm).


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