EORLA to use Elecsys® Anti-SARS-CoV-2 antibody test that helps determine exposition to the virus and development of antibodies
OTTAWA, ON, Aug. 4, 2020 /CNW Telbec/ – Roche Diagnostics, a division of Hoffmann-La Roche Limited, and the Eastern Ontario Regional Laboratory Association (EORLA) are pleased to announce a major collaborative research initiative on SARS-CoV-2 serology. The EORLA research team will conduct a randomized seroprevalence study of 4,400 people in Eastern Ontario to identify how many have been infected with SARS-CoV-2 and for how long those antibodies remain detectable in the body.
“Our objective is to establish an estimate of the number of Eastern Ontario residents who have been exposed to SARS-CoV-2, but may not be aware of their exposure,” said Dr. Christopher McCudden, Deputy Chief Medical/Scientific Officer at EORLA and leader of the study. “We will aim to quantify this exposure first among high-risk hospital out-patients. They are mobile, living in the community, but still need to come to hospital for regular blood tests and follow-up.”
The study is also intended to learn more about the pattern by which the amount of antibodies rises and falls over time in SARS-CoV-2 patients. By doing so, EORLA researchers hope to determine the longevity of antibody production in patients, critically important to pandemic response and recovery planning, with wide applications and benefits both regionally and nationally. The study will cover the Champlain Region of Ontario, which includes the National Capital Region and communities east of Algonquin park between the Quebec and New York state borders.
“We are proud to partner with the EORLA for this seroprevalence study using Elecsys® Anti-SARS-CoV-2 antibody test, which we are confident will bring reliable results to better manage the COVID-19 health crisis in Ontario,” said Michele D’Elia, Medical Director of Roche Diagnostics. “This study will help answer key questions about COVID-19 epidemiology and immunity and is one of our many efforts across the country to help better understand the dynamics of the pandemic in Canada.”
Study results will be invaluable to workers in long-term care homes, regional health centres and hospitals, and the community at large. Further, the study could provide a better understanding of the extent of herd immunity.
About antibody testing
An antibody test, also called a serology test, is used to determine whether a person might have mounted an immune response against a pathogen or not. In the current situation of the COVID-19 pandemic, antibody tests need to be able to specifically detect antibodies against SARS-CoV-2 with no cross-reactivity to other similar coronaviruses, which could generate a false positive result and thus wrongly indicate potential COVID infection. A false positive result happens when a person receives a positive test result, when they should have received a negative result. False positives are particularly critical when we do not know how many people in a given population have been exposed to the virus.
The Eastern Ontario Regional Laboratory Association (EORLA) is a member-owned, non-profit organization encompassing the operation of 18 licensed, acute-care, hospital-based clinical laboratories that service clinical programs across the Champlain Region of Eastern Ontario. A leading, innovative model of integrated laboratory practices in the province, the purpose of EORLA is to deliver patient-focused, consistent, high-quality and cost-effective hospital-based laboratory services to meet the needs of the region’s patients. EORLA laboratories provide diagnostic testing to both hospital inpatients and registered outpatients, performing a total of approximately 13 million tests annually. Comprehensive testing in the disciplines of Anatomic Pathology, Biochemistry, Transfusion Medicine, Hematopathology, and Microbiology/Virology is performed. For more information, visit www.eorla.ca.
About Elecsys® Anti-SARS-CoV-2 serology test1
Elecsys® Anti-SARS-CoV-2 is an immunoassay for the in-vitro qualitative detection of antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and plasma. Through a blood sample, the test, which is based on an in-solution double-antigen sandwich format, can detect antibodies to the new coronavirus causing COVID-19, which could signal whether a person has already been infected and potentially developed immunity to the virus. Based on the measurement of a total of 10,453 samples, the Elecsys® Anti-SARS-CoV-2 assay has 99.80% specificity and shows no cross-reactivity to the four human coronaviruses causing common cold. This means it can lower the chance of false positives due to the detection of similar antibodies that may be present in an individual, but are specific for coronaviruses other than SARS-CoV-2. Elecsys® Anti-SARS-CoV-2 detected antibodies with 99.5% sensitivity in samples taken 14 days after a PCR-confirmed infection. The importance of specificity and sensitivity of a particular test will be dependent on its purpose and disease prevalence within a given population.
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 www.roche.com.
1 Full specifications of Roche’s Elecsys® Anti-SARS-CoV-2 antibody test and immunoassay systems, including throughput, can be found on the website at: https://www.rochecanada.com/content/dam/rochexx/roche-ca/products/docs/package_inserts/Can%20Elecsys%20Anti-SARS-CoV-2-09203095190-V2-PI-En-E1G.pdf.
SOURCE Roche Diagnostics
For further information: Lynda Farant, Performance Manager, Eastern Ontario Regional Laboratory Association, 501 Smyth Road, Ottawa, ON K1H 8L6, T: 613.737.8899 x79107, C: 613.299.6379, firstname.lastname@example.org; Media Relations, Roche Diagnostics Canada, T: 450.686.3138