Roche has announced the launch of its Elecsys^® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark,. The company have also an application for US FDA-EUA in progress.

The Elecsys Anti-SARS-CoV-2 serology test can be used to quantitatively measure SARS-CoV-2 antibodies in people and can play an important part in characterising a vaccine-induced immune response.¹

Through a blood sample, the test can measure the quantity of antibodies to the spike protein of the coronavirus, which could signal whether a person has been already infected and potentially developed immunity to the virus. The test has both a high clinical specificity of 99.98% (N=5991) and sensitivity of 98.8% (N=1423), 14 days or later after diagnosis with PCR. 

Additionally, across panels of potentially cross-reactive samples (N=1100) from endemic human coronaviruses, infectious respiratory diseases, other infectious diseases, auto-immune and liver related diseases, the test demonstrated zero cross-reactivity.

Hospitals and reference laboratories can run the test on Roche’s cobas e analyzers which are widely available around the world. These fully-automated systems can provide SARS-CoV-2 test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyzer.³

“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", said Thomas Schinecker, CEO Roche Diagnostics.

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.² Measuring antibody levels could also be vital in establishing vaccine efficacy in the prevention of infection and/or the development of severe COVID-19.¹

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.³

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 which help diagnose and manage COVID-19 during the initial stages of infection, during the recovery phase, as well as following the resolution of infection.

References:

1. Zhu FC et al. (2020). Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial. The Lancet 396:479 - 4882)
2. Masters PS (2006). The molecular biology of coronaviruses. Advances in Virus Research. Academic Press. 66: 193–292; (2) Hoffmann, Markus et al. (2020). Cell. 81(2):271-280.e8;
3. Full specifications of the Roche immunoassay systems, including throughput, can be found on our diagnostics.roche website