The U.S. Food and Drug Administration approved the first diagnostic test for use in the U.S. to diagnose Zika virus immunoglobulin, or IgM, antibodies in human blood.
Seattle, Wash.-based InBios International Inc.'s ZIKV Detect 2.0 IgM Capture ELISA is designed to identify proteins produced by body's immune system when it tests for the Zika virus infection in the blood. IgM antibodies indicate an early immune response to particular antigens, such as bacteria or viruses, and aid in their destruction.
Zika virus is spread mainly by the bite of an infected Aedes species mosquito. While many people with Zika virus infection experience no symptoms, the virus can pose potentially serious risks to the public health.
The FDA's approval was based on the data from a study of 807 test samples and several analytical studies, which showed that the test was safe and effective in identifying IgM antibodies against Zika virus in blood.
The test has been approved to be used only in patients with clinical signs and symptoms consistent with Zika virus, and/or in patients who meet the Centers for Disease Control and Prevention's Zika virus epidemiological criteria. The test results are intended to be used with clinical observations, patient history, epidemiological information and other laboratory evidence to make patient management decisions.
Previously, the FDA had granted authorization to 18 tests for detecting Zika virus in emergency situations. The U.S. regulator is communicating with the manufacturers of four tests that are similar to InBios' test to gather information in order to evaluate whether it should revoke the emergency use authorization for these specific tests.