FDA Publishes First Validation Results Of 16 COVID-19 Antibody Tests

The U.S. Food and Drug Administration (FDA) has posted initial validation results of 13 antibody tests for coronavirus disease 2019 (COVID-19), or SARS-CoV-2, and on June 4, 2020, posted results for three more tests. During March and April 2020, the FDA granted the tests an Emergency Use Authorization (EUA). The validation analysis is based on information submitted by the test developers, which the FDA reviewed before granting the EUA. In addition to the 16 antibody tests authorized under an individual EUA, over 200 more antibody tests are being evaluated in a pre-EUA or EUA review . . .