WASHINGTON, May 23 (Xinhua) -- The U.S. Food and Drug Administration on Thursday approved a diagnostic test to detect Zika virus antibodies in human blood, the first of its kind authorized for marketing in the United States.
The test method called "ZIKV Detect 2.0 IgM Capture ELISA" is designed to identify proteins (antibodies) produced by the body's immune system when it tests for Zika virus infection in the blood, since immunoglobulin (IgM) antibodies indicate an early immune response, according to the FDA.
The Zika virus is spread to people primarily through the bite of an infected Aedes species mosquito. The Zika infection is linked with an abnormal smallness of the head of babies during their mothers' pregnancy.
The FDA reviewed data from a clinical study of 807 test samples and a variety of analytical studies, which demonstrated that the test was safe and effective in identifying IgM antibodies against Zika virus in blood.
The test method is for use only in patients with clinical signs and symptoms consistent with Zika virus infection or who meet the 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, according to FDA.
