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

The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus

17 Sept 2020
Diane Li
Assistant Editor

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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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AntibodiesAntibodies are used in techniques such as confocal and fluorescence microscopy, flow cytometry, ELISA, ELISPOT, immunohistochemistry, western blotting and immunopreciptation. Select specific antigen reactivity, high specific affinity, low non-specific binding, monoclonal or polyclonal, primary or secondary antibodies and associated conjugates such as an enzyme or dye for visualization.Combinatorial ChemistryCombinatorial chemistry, also known as combichem, is a technique used in drug discovery to create libraries of structurally related compounds. A library is generated by synthesis with a chemical reactor system or by computer-based modeling of compound combinations. When undertaking combinatorial chemistry consider reagents, buffers, resins and standards.Data AnalysisData analysis hardware and software is available to make data processing straight-forward yet powerful. Data software can be used for math and stats, technical graphing and image analysis. In addition, software is available for specific data analysis of electrophoresis, densitometry, ELISA and DNA sequencing.ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Cellular PathologyCellular Pathology deals with the microscopic analysis of tissue samples and cells. Sample preparation and processing includes fixation, staining, sectioning and slide mounting, using equipment such microtomes and cryostats. In choosing immunohistochemistry and immunocytochemistry kits, consider chromogens, staining method, antibodies, microscopes and imaging.Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.Clinical TrialsClinical Trials, an essential part of drug discovery process, assess the safety and effectiveness of a new medication or device in the pharmaceutical industry. Clinical Trials are a phased process (Phase 0, Phase I, Phase II, Phase III and Phase IV) which begins after initial preclinical testing.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.Clinical GeneticsMolecular Genetics covers the analysis of hereditary genetic disease and chromosomal abnormalities. Genetics can be analysed using DNA, RNA, and protein microarrays, PCR, RT PCR and DNA sequencing. Genetic equipment includes genetic workstations, thermal cyclers, cooling blocks and electrophoresis products. Diagnostic kits are used for DNA / RNA extraction and purification.Clinical MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Drug DeliveryDrug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services. Respiratory InfectionsRespiratory infections are caused by pathogens such as bacteria, viruses, and fungi, leading to diseases like pneumonia, tuberculosis, and COVID-19. It is important to identify respiratory infections quickly in patients to ensure appropriate treatment and care, and to prevent sepsis. Browse our peer-reviewed product directory to find the best tools for respiratory infection detection, compare products, check reviews, and get pricing directly from manufacturers.Vaccine DevelopmentVaccine development focuses on creating immunizations to protect against infectious diseases. The process involves identifying antigens, developing and testing vaccine efficacy, and ensuring safety through preclinical testing and multiple clinical trial phases. Scientists use various approaches, including weakened or inactivated viruses, protein subunits, or mRNA. Advanced platforms and rapid diagnostic tools aid in vaccine research and testing. Explore vaccine development solutions in our peer-reviewed product directory; compare products, read reviews, and get pricing directly from manufacturers. PharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.Human SerumHuman serum is found in blood plasma. The protein is used in a variety of applications including tissue engineering, transplantation and cell therapy.

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