FDA Issues Emergency Use Authorization for Zika Diagnostic Tool
HealthDay News — The U.S. Food and Drug Administration has issued an Emergency Use Authorization (EUA) for a diagnostic tool for Zika virus that will be distributed to qualified laboratories, according to a media statement issued by the U.S. Centers for Disease Control and Prevention.
The test is called the CDC Zika immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA), and is intended for use on blood samples from people with a history of symptoms associated with Zika and/or people who have recently traveled to an affected area. The IgM antibodies in response to infection appear in the blood beginning four to five days after the start of illness and last for about 12 weeks.
When positive or inconclusive results occur, additional testing with a plaque reduction neutralization test is recommended to confirm the presence of antibodies to Zika virus. This additional testing will be performed by the CDC or a CDC-authorized laboratory.
"The CDC will begin distributing the test during the next two weeks to qualified laboratories in the Laboratory Response Network, an integrated network of domestic and international laboratories that can respond to public health emergencies," according to the media statement. "The test will not be available in U.S. hospitals or other primary care settings."