FDA allows new tools for testing of Zika virus

The U.S. Food and Drug Administration has made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests for Zika.








In 2017, there were 203 cases of symptomatic Zika virus reported in the United States, according to the Centers for Disease Control and Prevention.

The FDA’s sample panel is comprised of plasma samples from anonymous patients infected with the Zika virus, West Nile virus, or dengue virus.

“At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with manufacturers to encourage the development of diagnostic tests and ensure they were available using its Emergency Use Authorization authorities,” FDA Commissioner Dr. Scott Gottlieb, said in a press release.

“By providing manufacturers of these tests with standardized patient samples to use in properly validating these diagnostics, we will be able to better assess how well their tests perform. This is part of our effort to ultimately bring these tests through the FDA’s formal review process to better ensure their reliability, and to enable broader access to Zika diagnostic testing.”

The panel is not for research but diagnostic developers can use the samples to determine if their tests are effective at distinguishing recent Zika infection from West Nile or dengue virus infection.

The panel is available to developers who have communicated with the FDA through the pre-Emergency Use Authorization, or EU, process and are using devices in the final stages of validation.

The use of the same serological panel can help public health professionals compare the effectiveness of different Zika virus tests.

By Amy Wallace