CE marking of bioMérieux serology tests for SARS-CoV-2 on VIDAS®27 May, 2020
bioMérieux, a world leader in the field of in vitro diagnostics, today announced the CE marking of VIDAS® anti-SARS-CoV-2 serology tests to detect antibodies in people who have been exposed to SARS-CoV-2 which causes the COVID-19 disease.
VIDAS® anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG are used to measure 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 delivers a negative result. Both VIDAS® anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG provide results in less than 30 minutes and demonstrate excellent performance on a large number of clinical specimens, with 99.6% and 100% specificity, respectively.
“We are pleased to provide laboratories with high quality serology tests for the confirmation of SARS-COV-2 infections. Specialized in the development of diagnostic solutions to fight infectious diseases for over 55 years, bioMérieux now offers a wide range of tests that meet the needs of health professionals in a variety of clinical situations related to patients’ conditions in the context of the COVID-19 pandemic,” said François Lacoste, Executive VP R&D at bioMerieux.
From now on, the tests are available in Europe and in countries that recognize CE marking. Hospital and private laboratories will be able to run the tests on bioMérieux’s VIDAS® systems (MINI VIDAS®, VIDAS® and VIDAS® 3) which are widely used with more than 30 000 systems installed around the world.
bioMérieux is planning to submit a request for Emergency Use Authorization (EUA) to the US Food and Drug Administration shortly.