December 2, 2020 – Roche announced that its Elecsys Anti-SARS-CoV-2 S antibody test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).
The serology test can be used to measure the level of antibodies in people who have been exposed to the SARS-CoV-2 virus. The EUA in the U.S. follows the launch of the Elecsys Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark announced September 18.
In addition to its role in helping to measure a patient’s immune response, the test may help guide the allocation of plasma donations from recovered COVID-19 patients to current patients by identifying donors that have antibodies to SARS-CoV-2 virus. Convalescent plasma therapy is an investigational procedure that separates and removes the plasma from a patient’s blood.
The laboratory-based Elecsys Anti-SARS-CoV-2 S test runs on Roche’s widely available cobas e analyzers and is the latest addition to Roche’s diagnostic portfolio to help healthcare systems combat COVID-19 through testing in the laboratory and at the point of care. Currently, the portfolio includes molecular, serology and digital solutions that help healthcare professionals diagnose COVID-19 and provide optimal patient care during the initial stages of infection and the recovery phase, as well as following the resolution of infection.