FDA grants market authorisation for Zika diagnostic test
A Zika diagnostic test developed by Washington University School of Medicine in St. Louis was newly granted market authoriSation by the Food and Drug Administration (FDA).
Chicago: A Zika diagnostic test developed by the Washington University School of Medicine in St. Louis was newly granted market authoriSation by the Food and Drug Administration (FDA).
According to a press release posted on the website of the university on Wednesday, using an antibody as well as other components to detect anti-Zika antibodies in the blood of people recently infected with the virus, the test can detect signs of Zika infection in serum samples within 12 weeks of infection, the Xinhua news agency reported.
The test is not meant to be used as stand-alone proof of infection. The FDA recommends that the test be used only for people with symptoms of recent infection, as well as a history of living in or travelling to geographic regions where Zika circulates. Positive results should be confirmed in accordance with guidelines from the Centers for Disease Control and Prevention.
Zika virus can cause babies to be born with devastating brain damage. But the signs of Zika infection in adults: rash, fever, headache and body aches, are nonspecific, so a pregnant woman who develops such symptoms can't be sure if she has contracted Zika or something less risky for her fetus.
"This test, along with another that detects viral genetic material at very early stages of infection, will help women and their doctors make informed health-care decisions," said Michael S. Diamond, a co-inventor of the technology that underlies the test and a professor of molecular microbiology and of pathology and immunology at Washington University.