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Roche Nabs CE Mark for SARS-CoV-2 Quantitative Antibody Test

NEW YORK – Roche announced Friday its SARS-CoV-2 quantitative antibody test received CE marking.

The Elecsys Anti-SARS-CoV-2 S test measures the level of antibodies against the region of the viral spike protein that binds to the host cell receptor in patients who have been exposed to the virus. The spike protein has been the focus of multiple vaccines in development, and Roche's test can also be used to characterize a vaccine-induced immune response by measuring the starting level of antibodies.

The test has a specificity of almost 100 percent and a sensitivity of nearly 99 percent in samples at least two weeks out from a diagnosis with PCR, according to Roche. The assay runs on Roche's Cobas E analyzer which can return results in 18 minutes with a throughput of up to 300 tests per hour.

The immunoassay can also be used to determine antibody levels in plasmapheresis donations, the company said in a statement. It can be used alongside the Elecsys Anti-SARS-CoV-2 test to determine seroprevalence in a population.

The Basel, Switzerland-based company has also filed for Emergency Use Authorization from the US Food and Drug Administration for the test.