Roche’s COVID-19 Test Gets FDA Emergency Clearance

The FDA has granted Roche Emergency Use Authorization for its Elecsys Anti-SARS-CoV-2 S antibody test.

The lab-based blood test, which received CE mark certification in September, is used to gauge the level of antibodies in patients exposed to the coronavirus to measure their immune response, providing a numerical result. The test runs on the company’s cobase analyzers.

The diagnostic can also be used to help with the allocation of plasma donations from recovered COVID-19 patients to infected patients by identifying donors with antibodies to the virus, the company said.