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FDA Approves First Zika Diagnostic Test for Commercial Use

The U.S. Food and Drug Administration (FDA) on Friday approved the use of a tool to diagnose a Zika virus infection after an emergency request by the U.S. Centers for Disease Control and Prevention.

The test, called the CDC Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA), is intended for use in detecting antibodies that the body makes to fight off the Zika virus after infection. The test can detect antibodies in blood beginning four to five days after onset of symptoms.

Until now, there has been no FDA-approved commercial diagnostic test for Zika. The FDA made the test available under Emergency Use Authorization (EUA), a label reserved for public health emergencies that have “significant potential to affect national security or the health and security of United States citizens.” This designation is determined by the U.S. Secretary of Health and Human Services.