The Elecsys® Anti-SARS-CoV-2-S test can detect the level of antibodies to the spike protein of the SARS-CoV-2 coronavirus. Since the spike protein is the target of many COVID-19 vaccines, this test may be used to characterize vaccine-induced immune response.
LAVAL, QC, April 6, 2021 /CNW Telbec/ - Roche Diagnostics, a division of Hoffmann-La Roche Limited, is pleased to announce the approval of its new Elecsys® Anti-SARS-CoV-2-S (spike protein) test under Health Canada's Interim Order increasing Roche's contribution to the fight against the pandemic.
"We are proud of what we have accomplished so far to support the efforts of Health Canada, the Public Health Agency of Canada (PHAC) as well as provincial public health authorities and laboratories against the ongoing pandemic, said François Drolet, Director, Public Affairs at Roche Diagnostics. This test will help the scientific and medical community to better understand the human reaction to the virus. The resulting data from the Elecsys® Anti-SARS-CoV-2-S antibody test can play a pivotal role in vaccine clinical trials helping clinicians assess patients' immune response".
The new Elecsys® Anti-SARS-CoV-2-S test measures the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus or vaccinated, which is important in establishing potential immunity and vaccine efficacy. This immunoassay targets antibodies against the viral spike protein, specifically its receptor-binding-domain (RBD), which is the common target for virus neutralizing antibodies and the focus of therapeutics and vaccine design.
"The presence and level of such antibodies could signal whether a person has already been infected and potentially developed immunity to the virus, said Michele D'Elia, Director, Medical Affairs at Roche Diagnostics. These antibodies have been shown to have potent antiviral activity and correlate to potential immunity. Measuring antibody levels could also be important in establishing vaccine efficacy in the prevention of infection and/or the development of severe COVID-19.1"
The Elecsys® Anti-SARS-CoV-2-S test is the latest addition to the comprehensive Roche Diagnostics 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.
In Canada, Roche Diagnostics is diligently offering its COVID-19 screening solutions to laboratories and taking the necessary measures to help reduce the consequences of the pandemic. The company praises the efforts of healthcare providers and frontline workers in communities all around Canada.
The Elecsys® Anti-SARS-CoV-2-S is an immunoassay for the in vitro qualitative and semi-quantitative detection of antibodies to SARS-CoV-2 spike protein receptor binding domain in human serum and plasma. Through a blood sample, the test is intended as an aid to assess the adaptive humoral immune response to the SARS–CoV–2-S protein. The test may also detect a response to vaccination2.
The test has both a high clinical specificity of 99.97% (N=13 871) and sensitivity of 98.8% (N=1423), 14 days or later after diagnosis with PCR. Additionally, across panels of potentially cross-reactive samples (N=1468) 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 in Canada and 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 a leading healthcare company, we are committed to minimize the impact of COVID-19, and help save and improve lives.
Roche's fight against the pandemic includes:
Launching COVID-19 diagnostic tests for active infection and the detection of antibodies in patients who have been exposed to the virus
Investigating treatments from our existing portfolio to better understand their potential to treat patients with COVID-19
Increasing manufacturing and supply chain capacity to meet product demand across our portfolio within the wider context of COVID-19 treatment
Ensuring the supply of our existing medicines and diagnostics to patients under exceptional conditions.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. For more information, please visit
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References
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).
The performance of the device has not been assessed on specimens from individuals who have been infected with emerging variants of SARS-CoV-2 of public health concern.
Full specifications of the Roche immunoassay systems, including throughput, can be found on
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