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Roche SARS-CoV-2 Antibody Test Garners FDA EUA

NEW YORK – Roche announced Sunday its SARS-CoV-2 antibody test received Emergency Use Authorization from the US Food and Drug Administration.

Roche's test is also now available in countries accepting the CE mark. 

The Elecsys Anti-SARS-CoV-2 antibody test, which runs on Roche's Cobas e analyzers, helps determine if a patient has been exposed to the virus and developed antibodies against it. The test is based on an in-solution double-antigen sandwich format and can detect antibodies, including IgG, from a blood sample. Results are provided in approximately 18 minutes, and up to 300 tests can be run every hour.

The immunoassay has greater than 99.8 percent specificity and 100 percent sensitivity in samples taken two weeks after a PCR-confirmed infection, which "is crucial to support healthcare systems around the world with a reliable tool to better manage the COVID-19 health crisis," Roche CEO Severin Schwan said in a statement.

The company said it will provide high double-digit millions of tests in May and will ramp up testing capacity further. Roche detailed its plans for the serology test during its conference call to discuss financial results last month.