Quantitative Antibody Test Measuring SARS-CoV-2 Antibodies Announced

A Switzerland based company announced the launch of the Elecsys® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark.

Roche’s 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.

On September 18, 2020, Riche announced this new diagnostic 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.

Thomas Schinecker, CEO Roche Diagnostics, comment in a press release: "This is the 12th in the Roche SARS-CoV-2 testing portfolio, and is another essential addition to support healthcare systems and patients as we jointly fight COVID-19.”

“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,” added Schinecker.

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.

The test is the latest addition to the comprehensive Roche diagnostic portfolio to help healthcare systems combat COVID-19 through testing in the laboratory and at the point of care. Currently, this portfolio includes molecular, serology, and digital solutions that help diagnose and manage COVID-19 during the initial stages of infection, during the recovery phase, as well as following the resolution of infection.

Roche announced it has also filed for Emergency Use Authorisation from the U.S. Food and Drug Administration (FDA).

As of September 17, 2020, the FDA  had authorized 248 coronavirus diagnostic tests under EUAs, which include 198 molecular tests, 46 antibody tests, and 4 antigen tests.

CoronavirusToday publishes research-based diagnostic news related to the COVID-19 pandemic.