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COVID-19 Update: FDA Shares Antibody Test Performance Data

June 5, 2020


The U.S. FDA posted test performance data from four more antibody, or serology, test kits on 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.

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