FDA authorizes first independently verified SARS-CoV-2 antibody test

The Food and Drug Administration yesterday authorized the first serology test in which independent federal data provided the scientific evidence used to support the authorization.

EUROIMMUN US Inc.’s Anti-SARS-CoV-2 ELISA (IgG) test, which will aid in identifying individuals with an adaptive immune response to SARS-CoV-2, is certified for emergency use by Clinical Laboratory Improvement Amendments-certified labs.

FDA said the results that secured the test’s authorization are among the first to come from a collaborative effort by the FDA, National Institutes of Health, Centers for Disease Control and Prevention and Biomedical Advanced Research and Development Authority to evaluate certain serological tests.