Roche Diagnostics India launchesQuantitative Test To Measure Antibody Levels Against SARS-CoV-2 - Songoti

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Roche Diagnostics India launchesQuantitative Test To Measure Antibody Levels Against SARS-CoV-2

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 Mumbai: Roche Diagnostics India announced the launch of its antibody test SARS-CoV-2 test - Elecsys Anti-SARS-CoV-2 S. The test is CE IVD approved and has received ICMR and CDSCO approval in INDIA.It is an in vitro test, that quantifies antibodies against the receptor-binding domain (RBD) of spike (S) protein SARS-CoV-2 in human serum and plasma, and determines the body’s immune response 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 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and can play an important part in characterising a vaccine-induced immune response.1 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.2 The majority of current

vaccines (approved and in development) aim to induce antibody response against the viral spike protein. As we move forward, the antibody testing will be useful to assess immune response.

Narendra Varde, Managing Director - Roche Diagnostics India, said, “Roche is firmly committed to providing reliable, high-quality testing solutions to help the country deal with the pandemic. The newest antibody solution, Elecsys Anti-SARS-CoV-2 S,  will not only give a ‘positive’ or ‘negative’ result, but also will provide a numerical result to indicate the concentration of SARS-CoV-2 specific antibodies in the blood, further supporting the healthcare systems and patients as we jointly fight COVID-19.”

Dr. Sandeep Sewlikar, Head of Medical & Scientific Affairs - Roche Diagnostics India, pointed out the need for an antibody test for India by stating:“Our new antibody assay, Elecsys Anti-SARS-CoV-2 S, detects and at the same time quantifies antibodies, which are directed against the viral spike protein, specifically the receptor-binding domain (RBD). This means Elecsys Anti-SARS-CoV-2 S not only tells you if someone has antibodies but also how many. The result is provided in the form of an antibody concentration (U/mL).”

In vaccine trials, 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.3 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

Roche’s new Elecsys Anti-SARS-CoV-2 S antibody test has a clinical specificity of 99.98%, with a 95% lower confidence limit of 99.91%; determined in 5991 pre-pandemic patient samples and a clinical sensitivity of 98.8%, with a 95% lower confidence limit of 98.1%; determined in 1423 samples with a sampling date of 14 days or later after diagnosis with PCR. This means it can lower the chance of false positives due to the detection of similar antibodies that may be present in an individual due to causesother than SARS-CoV-2. As we come to know more about immunity against SARS-CoV-2, this test in the future could help determine who has developed immunity against thevirus.

Alongside its importance to vaccine 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 ease lockdown restrictions.

The Elecsys Anti-SARS-CoV-2 S immunoassay runs on Roche’s widely availablecobas e analyzers, and these fully automated systems can provide SARS-Cov-2 test results in approximately 18 minutes for one test, with a test throughput of up to 300 tests/hour, depending on the analyzer.4

The test is the latest addition to the comprehensive Roche diagnostic portfolio to help healthcare systems combat COVID-19 through testing in the laboratory. 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.

 

All Trademarks and Tradenames are the property of their respective owners.

ELECSYS and COBAS are Trademarks of Roche

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