Roche’s COVID-19 antibody test receives EUA

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May 4, 2020—Roche announced that the FDA has issued an emergency use authorization for its Elecsys Anti-SARS-CoV-2 antibody test.

The Elecsys Anti-SARS-CoV-2 is an immunoassay for the in vitro qualitative detection of antibodies (including IgG) to SARS-CoV-2 in human serum and plasma. Through a blood sample, the test, which is based on an in-solution double-antigen sandwich format, can detect antibodies to the coronavirus causing COVID-19. Based on the measurement of a total of 5,272 samples, the assay has 99.81 percent specificity and 100 percent sensitivity in samples taken 14 days after a PCR-confirmed infection.

Hospitals and reference laboratories can run the test on Roche’s Cobas e analyzers, which provide SARS-CoV-2 test results in about 18 minutes for one test, with a test throughput of up to 300 tests per hour, depending on the analyzer.