FDA provides standardized patient samples for Zika virus test evaluation

The U.S. Food and Drug Administration (FDA) recently announced that it made available a panel of human plasma samples for regulatory evaluation of serological tests to detect recent Zika virus infection.

“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,” FDA Commissioner Scott Gottlieb, said. “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 consists of plasma samples from anonymous individuals infected with Zika, West Nile or dengue viruses. Developers of tests to detect Zika can use the samples to determine the effectiveness of their tests in distinguishing Zika infection from infection with West Nile and dengue viruses.

Using a standard serological panel will aid public health professionals in comparing Zika virus tests.

The panel is available to developers who have communicated with the FDA through the pre-Emergency Authorization Use (EAU) process and have tests in the final stages of validation. The FDA has so far granted EUAs to three serological tests for detection of recent Zika virus infection, Zika MAC-ELISA, ZIKV Detect IgM Capture ELISA and LIAISON XL Zika Capture IgM Assay. The FDA invited other developers interested in requesting a panel to contact the agency.