Roche Launches New Quantitative Antibody Test to Measure SARS-CoV-2 Antibodies

Roche (Basel, Switzerland) has launched its Elecsys Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark. The test targets antibodies against the spike protein and can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus.

The Elecsys Anti-SARS-CoV-2 serology test can be used to quantitatively measure antibodies in people who have been exposed to the SARS-CoV-2 virus and can play an important part in characterizing a vaccine-induced immune response. Specifically, the test targets antibodies which are directed against the particular region of the viral spike protein responsible for binding to the host cell receptor, which is required for the virus to enter the host cell.

The majority of current candidate vaccines aim to induce an antibody response against the spike protein. Before a vaccine is administered it is important to know the starting level of antibodies a person has, in order to evaluate any change in antibody levels that the vaccine induces, especially the development of antibodies directed against the SARS-CoV-2 spike protein. These antibodies have been shown to have potent antiviral activity and correlate to potential immunity. Measuring antibody levels could also be vital in establishing vaccine efficacy in the prevention of infection and/or the development of severe COVID-19.

Alongside its importance to vaccine design and efficacy evaluations, the Elecsys Anti-SARS-CoV-2 S serology test can be used to determine antibody levels in plasmapheresis donations. Performing a combination of the Elecsys Anti-SARS-CoV-2 S and Elecsys Anti-SARS-CoV-2 tests can also help to more effectively define what percentage of a given population has developed antibodies (seroprevalence) against SARS-COV-2, especially in low to moderate seroprevalence settings. Knowing a given population’s seroprevalence is important in understanding how to contain the spread of the virus, as well as how to safely ease lockdown restrictions. Roche has now filed for Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its Elecsys Anti-SARS-CoV-2 S antibody test.

“As the possibility of an effective SARS-CoV-2 vaccine becomes a reality, quantitative measurement of antibodies will be crucial in the evaluation of any potential vaccine. The new quantitative Elecsys antibody test can play a pivotal role in vaccine clinical trials as well as helping clinicians assess patients’ immune response. This will be instrumental in protecting people most vulnerable to the virus, as well as in overcoming COVID-19 for society in general.” said Thomas Schinecker, CEO Roche Diagnostics. "This new test, the twelfth in the Roche SARS-CoV-2 testing portfolio, is another essential addition to support healthcare systems and patients as we jointly fight COVID-19.”