The Food and Drug Administration (FDA) has made a panel of human plasma samples available to aid in the regulatory evaluation of serological tests to detect recent Zika virus infection. The panel consists of plasma samples from anonymous individuals infected with Zika, West Nile, or dengue viruses. Although these samples are not intended for research purposes, diagnostic developers can use them to assess whether their tests help distinguish recent Zika virus infection from infection with West Nile or dengue. Using a standardized serological panel to evaluate different devices available under emergency use authorization will help public health professionals compare the performance of different Zika virus tests. This is part of FDA’s effort to better ensure the reliability of Zika testing and enable broader access to it by eventually bringing Zika tests through the agency’s formal review process rather than the emergency use authorization pathway.
Zika tests that have recently received FDA emergency use authorization include a multiplex test for Zika, dengue, chikungunya, and West Nile viruses developed by Columbia University’s Mailman School of Public Health, as well as a Zika assay from Thermo Fisher Scientific.