FDA Nixes Chembio’s EUA for COVID-19 Antibody Test

The FDA has decided to revoke the Emergency Use Authorization (EUA) it issued for Chembio’s COVID-19 antibody test, citing concerns over its accuracy.

After analyzing data submitted by the company and conducting its own evaluation, the agency found that the antibody test, one of the first to receive the agency’s EUA during the pandemic, produced more false results than was indicated in its labeling.

“It is not reasonable to believe that the test may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of the test outweigh the known and potential risks of the test,” the agency said.