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Euroimmun COVID-19 Antibody Test Gets FDA Emergency Use Authorization

NEW YORK – PerkinElmer subsidiary Euroimmun announced after the close of the market on Tuesday that the US Food and Drug Administration has issued Emergency Use Authorization for the company's Anti-SARS-CoV-2 S1 Curve ELISA test for the detection of IgG antibodies against the coronavirus.

The test allows for the qualitative and quantitative detection of IgG in human serum and plasma. It is based on Euroimmun's Anti-SARS-CoV-2 QuantiVac ELISA test that received the CE mark in November 2020 and measures the concentration of antibodies against the S1 domain of the spike protein, including the receptor binding domain.

The assay can be run manually or with the Euroimmun's EuroLab Workstation ELISA, Sprinter XL, as well as other third-party ELISA platforms, Euroimmun said.

Separately, the FDA said the test should be used only for patients who are at least 15 days post-symptom onset.

"With this latest EUA of our semi-quantitative antibody test, more laboratories will have the ability to generate in-depth insights on immunity that advance future antibody therapies and vaccines for COVID-19," Euroimmun CEO Wolfgang Schlumberger said in a statement.