Global & Disaster Medicine» Blog Archive » CDC’s Zika MAC test has been cleared by FDA (Emergency Use Authorization) for detecting evidence of the virus in human sera or CSF

CDC’s Zika MAC test has been cleared by FDA (Emergency Use Authorization) for detecting evidence of the virus in human sera or CSF

February 27th, 2016

** the Zika MAC test is used to gauge recent infection and can detect the virus as early as 4 days after symptoms begin.

FDA approval letter

“….. the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of the Centers for Disease Control and Prevention’s (CDC) Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for the presumptive detection of Zika virusspecific IgM in human sera or cerebrospinal fluid (CSF)……”

This entry was posted on Saturday, February 27th, 2016 at 10:19 am and is filed under CDC, FDA, Zika virus .
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CDC’s Zika MAC test has been cleared by FDA (Emergency Use Authorization) for detecting evidence of the virus in human sera or CSF

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