Aug. 14, 2020—BioMérieux received emergency use authorization by the U.S. Food and Drug Administration 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 have demonstrated excellent clinical performance, with 100 percent sensitivity and 99.4 percent or greater specificity.