US FDA Releases Test Performance Data of COVID-19 Antibody and Serology Kits

The US Food and Drug Administration {(FDA) Silver Spring, MD, USA} has publicly posted test performance data from four more antibody, or serology, test kits from its independent performance validation study effort.

These results are among the first to come from the FDA’s collaborative effort with the National Institutes of Health’s (NIH) National Cancer Institute (NCI), Centers for Disease Control and Prevention (CDC) and Biomedical Advanced Research and Development Authority (BARDA). An intergovernmental team is leveraging NCI’s capability for the US 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 in early May and the FDA has now shared data from four additional tests. 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.

“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.”

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US Food and Drug Administration (FDA)