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Eurofins Gets CE Mark for Coronavirus Antibody Test

NEW YORK — Eurofins said on Thursday that it has received CE marking for its GSD NovaLisa SARS-CoV-2 antibody test.

The ELISA-based test is designed for the quantitative detection of immunoglobulin G against the SARS-CoV-2 spike protein and can be used to measure immune responses to the virus and vaccines, the Luxembourg-based company said. In clinical testing, the assay was able to detect target antibodies in 97 percent of patients 15 days after the onset of symptoms, with a diagnostic specificity of over 99 percent.

In 2020, Eurofins received CE marks for its GSD NovaGen SARS-CoV-2 rapid antigen test and its GSD NovaPrime SARS-CoV-2 PCR test.