COVID-19 Update: FDA Shares Antibody Test Performance Data

The U.S. FDA 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).

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.

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.