emergency use authorization approved

Roche’s COVID-19 Antibody Test Gets Emergency Use Authorization

May 5, 2020

Roche’s highly accurate Elecsys Anti-SARS-CoV-2 antibody test received an Emergency Use Authorization (EUA) from the FDA.  

Roche said it will begin supplying “high double-digit millions” of tests this month in the U.S. and in countries that accept the CE mark. The test runs on the company’s cobase analyzers.

The test has 100 percent accuracy in identifying those with COVID-19 infections and 99.8 percent accuracy in identifying those without the disease.

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