Roche SARS-CoV-2 test receives FDA EUA

Dec. 3, 2020

Roche announced that its Elecsys Anti-SARS-CoV-2 S antibody test has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA). The serology test can be used to measure the level of antibodies in people who have been exposed to the SARS-CoV-2 virus, according to a press release.

The EUA in the United States follows the launch of the Elecsys Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark.

The new test targets antibodies that are directed against the region of the novel coronavirus known as the spike protein; specifically,  the area that enables the virus to bind to a host cell receptor, which is required for the virus to enter the host cell. Many current candidate vaccines aim to induce an antibody response against the SARS-CoV-2 spike protein. Tests that quantify antibodies to the spike protein could be used to measure the level of that response and track that measurement over time.

In addition to its role in helping to measure a patient’s immune response, the test may help guide the allocation of plasma donations from recovered COVID-19 patients to current patients by identifying donors that have antibodies to SARS-CoV-2 virus.

The test provides a numerical result describing the concentration of antibodies from 0.40-250 U/mL as well as a qualitative result. The test has both a high negative percent agreement (NPA) of 99.98 percent and positive percent agreement (PPA) of 96.6 percent, 15 days or later after diagnosis with a PCR test, according to Roche.

The laboratory-based Elecsys Anti-SARS-CoV-2 S test runs on Roche’s cobas e analyzers.

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