Vidas SARS-CoV-2 antibody serology tests get EUA

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September 2020—BioMérieux received emergency use authorization by the FDA for its Vidas SARS-CoV-2 IgM and Vidas SARS-CoV-2 IgG serology tests.

The tests can detect, in less than 30 minutes, the presence of antibodies to the SARS-CoV-2 spike glycoprotein in people who have been infected with SARS-CoV-2 virus. Both tests demonstrated excellent clinical performance, with 100 percent sensitivity and 99.4 percent or greater specificity, and can run on the Mini Vidas, Vidas, and Vidas 3 systems.