FDA Publicly Shares Antibody Test Performance Data from Kits as Part of Validation Study

The U.S. Food and Drug Administration (FDA) publicly posted test performance data from four more antibody, or serology, test kits on open.fda.gov from its independent performance validation study effort with the National Institutes of Health’s (NIH) National Cancer Institute (NCI). These results are among the first to come from a collaborative effort by the FDA, NIH, Centers for Disease Control and Prevention (CDC) and Biomedical Advanced Research and Development Authority (BARDA). Additional performance data will be made available as the FDA reviews and determines if any further actions are appropriate for those test kits prior to publication.

An intergovernmental team is leveraging NCI’s capability for the U.S. Government to independently evaluate certain antibody tests, including antibody tests that were not the subject of an EUA or pre-EUA, as well as those that were under FDA review. Data from an antibody test kit were first posted on May 4, 2020. Today, the FDA has shared data from four additional tests.

“These data are the result of an important cross-government effort,” said FDA Commissioner Stephen M. Hahn, M.D. “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.”

“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,” said NCI Director Norman E. “Ned” Sharpless, M.D. “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.”

The testing was performed at the Frederick National Laboratory for Cancer Research, a Federally Funded Research and Development Center sponsored by NCI and through a collaborative effort with the FDA, NIH, CDC and BARDA to evaluate certain serological tests. Essential reference samples and materials used in the evaluation were provided by the NIH National Institute of Allergy and Infectious Diseases, the Mount Sinai Health System, the Icahn School of Medicine at Mount Sinai, including members of the Departments of Microbiology and Pathology, and the Vitalant Research Institute.