bioMérieux announces the CE marking of the new generation semi-quantitative VIDAS® SARS-COV-2 IgG II serology test.

bioMérieux, a world leader in the field of in vitro diagnostics, today announces CE marking of the new generation of IgG serology test with VIDAS® SARS-COV-2 IgG II to semi-quantitatively detect antibodies in people who have been exposed to the SARS-CoV-2 that causes the COVID-19 disease.

In 2021, on top of the importance of detecting COVID-19 virus, the emergence of variant strains and expansion of vaccination have generated new public health challenges. In particular, obtaining quantitative serological information by measuring antibody levels might provide important insights to help evaluate a person’s immune response following either natural infection or vaccination.

VIDAS® SARS-COV-2 IgG II offers a semi-quantitative interpretation of the level of IgG antibodies directed against the Receptor-Binding Domain (RBD) of the Spike (S) viral protein. Indeed numerous vaccines for COVID-19 are available, mostly focusing on eliciting an immune response to the RBD / S viral protein. Following an internal evaluation with two of the more common vaccines (Pfizer–BioNTech Comirnaty and Moderna mRNA-1273), it was demonstrated that this new VIDAS® assay will detect anti-SARS-Cov-2 IgG antibodies post-vaccination. Additionally, we have documented correlation of the IgG level results with the WHO international standard.

“Building on three decades of experience in immunoassays, the VIDAS® SARS-COV-2 IgG II will support labs with a solution adapted to new medical needs linked to the evolution of the COVID-19 pandemic.” declared François Lacoste, Executive Vice President, R&D, bioMérieux.

Hospitals and private laboratories can run this new test on bioMérieux’s VIDAS® analyzers (MINI VIDAS®, VIDAS® and VIDAS® 3) which are widely available with more than 30,000 systems installed around the world.

“bioMérieux is committed to fight against the spread of COVID-19 with both molecular biology and immunoassay solutions. Our large VIDAS® installed base and easy-to-use platform will provide a wide access to this new antibody test.” said Pierre Boulud, Chief Operating Officer, Clinical Operations, bioMérieux.