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.

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