Roche launches quantitative antibody test to measure SARS-CoV-2 antibodies

Roche has announced the launch of its Elecsys^® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark. Roche has filed for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA).

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 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.

“As the possibility of an effective SARS-CoV-2 vaccine becomes a reality, the 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.”

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.

About SARS-CoV-2

Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The novel coronavirus (SARS-CoV-2) is a new strain that has not previously been identified in humans.

Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing, and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure, and death can occur.

About potential SARS-COV-2 vaccines

As of 3 September 2020, 47 candidate vaccines are in clinical evaluation and 3 vaccines have been approved for early or limited use, while at least 91 preclinical vaccines are under active investigation. All candidate vaccines in Phase III or approved for limited/early use aim to induce an antibody response against the SARS-CoV-2 spike protein. Any potential vaccine for SARS-CoV-2 would work (amongst other mechanisms) by triggering the immune response to develop neutralizing antibodies, in the person receiving the vaccine. In doing so, the vaccine trains the body’s immune system to recognize and fight exposure to SARS-CoV-2, in a controlled way, without being exposed to the actual virus.

About Elecsys Anti-SARS-CoV-2 S and Elecsys Anti-SARS-CoV-2 serology tests

The Elecsys^® Anti-SARS-CoV-2 S is an immunoassay for the quantitative, in vitro determination of antibodies to SARS-CoV-2 in human serum and plasma. Through a blood sample, the test can measure the number 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. This can also be used to determine antibody levels in plasmapheresis donations. Plasmapheresis is a procedure that separates and removes the plasma from a patient’s blood. This plasma is then replaced with plasma from a donor. It is assumed that plasma from a donor who has already had SARS-CoV-2 will have direct antiviral properties for the donor-recipient. This is being explored as an adjunctive treatment for the management of COVID-19.6 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.

*The Elecsys Anti-SARS-CoV-2 is an immunoassay for the qualitative, in vitro detection of antibodies (including IgG) to SARS-CoV-2. The test can detect antibodies to the coronavirus, which could signal whether a person has been already infected and potentially developed immunity to the virus. This test can also help in the determination of seroprevalence (i.e. the frequency of individuals with antibodies to the virus), in a given population, as well as a complementary test to Nucleic Acid Amplification Tests (NAAT) for the diagnosis of SARS-CoV-2 infection. The test runs on Roche’s cobas e analyzers which are widely available around the world.

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