FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies

The U.S. Food and Drug Administration May 23 authorized marketing of a diagnostic test for detecting Zika virus 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. Previously, tests for detecting Zika virus IgM antibodies—including the ZIKV Detect 2.0 IgM Capture ELISA—were authorized only for emergency use. The ZIKV Detect 2.0 IgM Capture ELISA – 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 – is designed to identify antibodies produced by the body's immune system in the blood. IgM antibodies indicate an early immune response.