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BioMérieux Obtains CE Mark for Semi-Quantitative SARS-CoV-2 Serology Test

NEW YORK ─ BioMérieux said on Monday that it has obtained CE marking for a next-generation IgG serology test, the Vidas SARS-CoV-2 IgG II, to semi-quantitatively detect antibodies in people who have been exposed to SARS-CoV-2, enabling its use in the European Union and other regions that accept the designation.

The test provides a semi-quantitative interpretation of the level of IgG antibodies directed against the receptor-binding domain of the spike viral protein, the firm said, adding that hospitals and private laboratories can run the test on its Vidas analyzers.

In an internal evaluation involving the Pfizer-BioNTech and Moderna vaccines, the assay demonstrated that it detects SARS-CoV-2 IgG antibodies post-vaccination, BioMérieux said. The company has further documented the correlation of the IgG-level results with a World Health Organization international standard.

Last week, Marcy l’Étoile, France-based BioMérieux announced that it had received the CE mark for its MALDI-TOF microbiology system, the Vitek MS Prime.