Coronavirus (COVID-19) Update: FDA Publicly Shares Antibody Test Performance Data From Kits as Part of Validation Study

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Coronavirus (COVID-19) Update: FDA Publicly Shares Antibody Test Performance Data From Kits as Part of Validation Study

Today, the U.S. Food and Drug Administration 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 ...

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