On May 6, 2020, bioMerieux announced performance validation and the upcoming launch of VIDAS® anti-SARS-CoV-2 serology tests to detect antibodies in people who have been exposed to the SARS-CoV-2 that causes the COVID-19 disease.

Building on years of experience in developing immunoassays, bioMérieux worked closely with several hospitals to develop and validate the performances of two tests. VIDAS® anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG will identify in less than 30 minutes the presence of antibodies in people who have been infected with SARS-CoV-2. In this context, clinical specificity is particularly important to ensure that testing of uninfected individuals consistently shows a negative result. Both VIDAS® anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG demonstrated excellent clinical specificity data.

Hospitals and private laboratories can run the tests 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 aims to have the VIDAS® anti-SARS-CoV-2 serology tests available by mid-May as RUO (Research Use Only). They will be CE marked rapidly thereafter and bioMérieux will file a request for Emergency Use Authorization (EUA) to the US Food and Drug Administration.