HHS approves emergency use of new Zika diagnostic test
AHA News Now
Feb 29, 2016
Health and Human Services Secretary Sylvia Burwell Friday approved an emergency use authorization for a test that can detect Zika antibodies in the blood from about four days to 12 weeks after infection. The Centers for Disease Control and Prevention expects to distribute the test over two weeks to qualified domestic and international laboratories in its Laboratory Response Network. According to the CDC, false-negative results can occur if the test is performed too early or late for sufficient antibodies to develop or remain in the blood. When positive or inconclusive results occur, the CDC or a CDC-authorized laboratory will perform additional testing to confirm the presence of Zika antibodies. “As with any test, it is important that health care providers consult with their patients about test results and the best approach to monitoring their health,” the agency said. CDC also is distributing a test for active Zika infection to the LRN, said CDC director Tom Frieden, M.D., noting that more than 20 U.S. labs can already perform the test using CDC materials. There are no commercially available Food and Drug Administration-approved tests for Zika virus infection.
Topic: Advocacy and Public Policy
Tags: preparedness, Zika