VITROS®Anti-SARS-CoV-2 Total Antibody Test from Ortho Receives Health Canada Approval

RARITAN, N.J., June 9, 2020 /CNW/ -- Aligned with its mission to improve and save lives with diagnostics, Ortho Clinical Diagnostics today announced Health Canada approval for its SARS-CoV-2 (COVID-19/coronavirus) Total antibody test?the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack.

"The unprecedented nature of this rapidly spreading virus required an immediate response from the diagnostics industry, and Ortho followed through on its commitment to help develop better ways to treat patients and provide robust data to help manage COVID-19," said Chris Smith, chief executive officer. "At Ortho Clinical Diagnostics, the patient is at the heart of everything we do?because we believe behind every test is a life."

The VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack detects antibodies (including IgA, IgG and IgM) to SARS-CoV-2 that may be used as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. It can be used to support back-to-work decisions and may be used to assess viral exposure for population tracking and surveillance.

"Ortho leveraged its history of innovation and history of advancing through science to quickly develop these solutions," said Chockalingam Palaniappan, PhD, chief innovation officer. "It's inspiring to think of the good the healthcare community can do by advancing the learning about this virus."

The test will run on Ortho's flagship analyzer, the VITROS^® XT 7600 Integrated System, the VITROS^® 3600 Immunodiagnostic System, the VITROS^® 5600 Integrated System and the VITROS^® ECi/ECiQ Immunodiagnostic Systems, all which can process up to 150 tests in an hour. The systems are designed to remove barriers and adaptable for non-traditional laboratory environments because they don't require an external water supply to run and are already installed in hospital and reference labs throughout Canada.

"Ortho Clinical Diagnostics is proud to bring a COVID-19 Total (IgA, IgM, IgG) antibody test to Canada which offers both 100% specificity and 100% sensitivity (following 8 days post-symptom onset), ensuring patients and clinicians alike can be confident in the results," said Andrew Corkum, President of Commercial Operations Canada. "This is a testament to our commitment to improve and save lives through diagnostics, because we believe every test is a life."

As a trusted partner of hospitals, hospital networks, blood banks, and labs around the world for over 80 years, Ortho has a rich history of developing solutions that provide fast, accurate, reliable testing results. The test was developed at Ortho's Global Center of Excellence for R&D in Rochester, New York.

Questions regarding the development of these COVID-19 antibody test can be directed to: [email protected].  

About Ortho Clinical Diagnostics

Ortho Clinical Diagnostics is a global leader of in vitro diagnostics dedicated to improving and saving lives through innovative laboratory testing and blood-typing solutions.

Because Every Test is a Lifetm, we never stop innovating to offer streamlined, sustainable laboratory solutions that deliver fast, accurate, reliable test results that support exceptional patient care.

For more information about Ortho's solutions and services, visit Ortho's website or social media channels: LinkedIn, Twitter, Facebook, Instagram and YouTube.

Press Contact:
Nancy Dessureault
Ortho Clinical Diagnostics
1-438-992-1985

SOURCE Ortho Clinical Diagnostics