Euroimmun COVID-19 Antibody Assay Curve Elisa Gets EUA

Euroimmun has received Emergency Use Authorization from the FDA for its Anti-SARS-CoV-2 S1 Curve ELISA (IgG) assay for detecting COVID-19 infections.

The test, which is both qualitative and semi-quantitative, identifies antibodies formed against the SARS-CoV-2 coronavirus from blood samples.

Clinical laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 can immediately begin using the test, according to Waltham, Mass.-based Euroimmun, a PerkinElmer subsidiary.

The test received a CE mark certification last November.