FDA Authorizes Marketing of the First Zika Antibody Diagnostic Test

May 30, 2019

On May 23, the U.S. Food and Drug Administration (FDA) authorized marketing of a diagnostic test to detect Zika virus immunoglobulin M (IgM) antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test the FDA has allowed to be marketed in the U.S.  Previous tests for detecting Zika virus IgM antibodies had been authorized only for emergency use under the FDA’s Emergency Use Authorization (EUA) authority.
FDA reviewed data from a clinical study of 807 test samples and a variety of analytical studies, which demonstrated that the ELISA test was safe and effective at identifying IgM antibodies against Zika virus in blood.
The test is for use only in patients with clinical signs and symptoms consistent with Zika virus infection, and/or who meet the Centers for Disease Control and Prevention’s Zika virus epidemiological criteria, such as history of residence in or travel to a geographic region with active Zika transmission at the time of travel.
To read more about the newly authorized test, see the FDA’s announcement here.