As part of a validation study, the U.S. Food and Drug Administration (FDA) publicly posted test performance data from four antibody test kits this week.
This independent performance validation effort is being undertaken alongside the National Institutes of Health’s National Cancer Institute (NCI). Additional data is expected as the FDA peruses test kit data and decides whether further actions are required before publication.
“These data are the result of an important cross-government effort,” FDA Commissioner Stephen Hahn said. “There’s been incredible teamwork across scientists at the FDA, NCI, CDC, and BARDA, and I’m glad to be sharing the data with the wider research community. By posting these data publicly, we’re advancing not only Americans’ access to trustworthy tests, but also the wider field of research into serology testing.”
The evaluation study covers antibody tests, including those that were not subject to an Emergency Use Authorization (EUA) or pre-EUA, and those under FDA review. For these four tests, testing was undertaken at the federally funded Frederick National Laboratory for Cancer Research. They include the newly authorized Euroimmun’s IgG ELISA test and Healgen’s IgG/IgM Rapid Test Cassette. Others addressed this week were either withdrawn or removed.
Previously, the FDA had allowed manufacturers of antibody test kits to distribute products without agency review, prioritizing speed. Companies were required to perform their own validation testing and submit the results. That course has since shifted, as the government moves to guarantee the efficacy of the many tests now out on the market.
“We’re pleased to step up and provide NCI’s laboratory capacity and expertise to support this crucial partnership to further our understanding of antibody test performances,” NCI Director Norman Sharpless said. “This speaks to the terrific convening power of the federal government and highlights the strength of cross-agency collaboration within the Department of Health and Human Services. NCI will continue to play its part by examining these kits and generating important data that supports FDA’s decision-making.”