Roche has launched its Elecsys Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark. The company also has filed for Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), according to a press release.
Roche said the Elecsys Anti-SARS-CoV-2 serology test can be used to quantitatively measure antibodies in people who have been exposed to SARS-CoV-2. Roche said the test also can play an important part in characterizing a vaccine-induced immune response. Specifically, the test targets antibodies that 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, Roche said.
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, Roche said. 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 evaluation, Roche suggested that 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.
