COVID-19: Rapid Antibody Test - Canadian group announces results of the latest independent performance evaluation of their Swiss-Canadian ZEKMED rapid antibody Test head to head with the CDC / FDA serology reference Kit Français
MONTRÉAL, Dec. 8, 2020 /CNW Telbec/ - Tridan/CBS group, a Québec-based company released today the performance results of a Swiss-made COVID-19 rapid test, ZEKMED, following a local clinical trial. The study was performed under GLP requirements between July and September 2020 at Cirion Biopharma to test Montreal Heart institute staff who were infected or had possibly been infected by SARS-CoV-2. A total of 339 blood samples, provided by Montreal Heart Institute were tested using both ZEKMED IgG/IgM rapid test and the Roche Elecsys Anti-Sars-CoV-2 laboratory assay approved by Health Canada and recently by the FDA as a vaccine efficiency follow up reference tool. Of the 339 specimens, the comparison made showed an agreement of 99%. Tridan/CBS group is still waiting for Health Canada to finally approve the ZEKMED rapid antibody Test. A production line is secured for Canada with 3 Million tests on Canadian soil on a weekly basis, a week after Health Canada grants the green light.
The comparison was made in triplicate by three different technicians with three different ZEKMED cassettes, reflecting an easy and efficient Point of care use and shows that there is negligible inter-operator divergence, and the agreement has been found to be excellent.
"I am happy with the performance of the ZEKMED rapid antibody test and quick results, it is suitable for use and could perfectly replace approved serological tests requiring phlebotomy and ease the burden on laboratories and hospitals at a fraction of the current testing cost. We are currently using these kits to establish monitoring protocols for staff and patients at risk at the ICM and protocols for safe opening of the EPIC centre," Said Dr. Richard Marchand, Physician, microbiologist, immunologist and infectiologist at the Montreal Heart Institute.
This latest independent performance evaluation of ZEKMED was conducted by CIRION Biopharma, one of the few CLIA laboratories in Canada. The results are in accordance with the conclusion of the results from the other three independent evaluations conducted in Russia, Switzerland and France.
Current deployed rapid antigen testing (Requiring nose and throat swab) could help detect super spreaders but could also miss cases and crucial information like an old infection and the presence of antibodies. They have limitations and are usually accurate only over a certain period of an infection on symptomatic individuals. That being said, if used alone, and outside this window, they would generate a high percentage of false negatives. "ZEKMED rapid test could help understand the viral dynamics for a safe reopening, using a simple blood prick and a finger size cassette," said Lionel Haddad, Engineer and Microbiologist, VP- Chief Scientific Officer at Tridan/CBS group. Schools, universities, hospitals, airports, manufacturing plants, offices and so many high traffic spaces could reopen safely and smartly. "The right tests combined with good testing methods. SOP's, algorithms and risk mitigation protocols are the only way for our societies to function in the short and long term," added Lionel Haddad. The group believes that being able to mass screen and diagnose the population on a large scale with available, functional, affordable and reliable rapid test kits represents one of the most crucial steps to ensure the safety of everyone, limit the spread of the infection and work steadily towards reopening the economy.
"It is TRIDAN/CBS group's commitment to keep fighting against this pandemic by conceiving new point of care testing tools in collaboration with our national and international partners and collaborators and ensure supplies to our country. Thanks to a great team, Mr. Luc Lavigne, president of Innovation diagnostics who helped in the regulatory requirements, Dr. Richard Marchand, known for his expertise in infectiology and immunology who supervised this study, as well as Dr. Olivier Mattmann, president of the International CBRNe Institute (ICI) and Nobel prize Laureate, we are confident that we have in our hands a safe and smart solution to get out of this dramatic situation and avoid unnecessary restrictions", Said Alexandre Triquet, President of Tridan/CBS group.
The test has the advantage of detecting accurately both IgM and IgG antibodies and could be used as part of risk mitigation protocols to release lockdowns gradually but securely as well as to organize, prioritize the logistics of the upcoming vaccines and evaluate their efficacy. This solution, along with the usual government recommendations, will help monitor the population on a weekly basis and get the workforce back on its feet. "The economic and mental health toll are becoming a big risk," concluded Lionel Haddad.
The study was carried out at CIRION BIOPHARMA PHARMA RESEARCH, a certified laboratory and one of the few contract research laboratories in Canada to have accreditation from the College of American Pathologists (CAP), which certifies that the laboratory and the procedures meet the quality assurance requirements of the Food and Drug Administration (FDA), as well as Clinical Laboratory Improvement Amendments (CLIA). CIRION also has the permits from the Laboratoire de Santé Publique du Québec (LSPQ) to operate as biochemistry, hematology and microbiology laboratory. It is also GLP certified by the Canadian Standards Council (SCC), and the Canadian verification authority.
About ZEKMED Rapid Test:
- CE-IVD certified
- ISO 13485 Certified
- 100% Europe Made - Manufactured and packed (Swiss and German - Certificate of origin of manufacturer issued from EU/ Switzerland)
- Specificity 99.9% Selectivity 97 % - total accuracy, 98.5 %, proven and confirmed by independent clinical trials.
- No cross-reactivity with other pathogens
- Registered and used in Italy, Switzerland, Germany, France, Russia, India, Lebanon, Chile, the Dominican Republic, Peru, Morocco and is pending in many other countries.
- Pending Health Canada Authorization
About TRIDAN/CBS
TRIDAN/CBS Group Inc. is a Canadian company led by experts in CBRN, (Chemical, Biological, Radiological, Nuclear Disaster Management), emergency medicine, microbiology, epidemiology and research. Tridan/CBS group provides disaster management services and algorithm solutions to several countries and organizations as well as high-quality product related to the detection of biological radiological and chemical hazards and data centralization. The group's partners are: Hotzone solution group – Zenum - Biopole scientifique de Lausanne- International CBRNe Institute- New Health Concept- Innovation Diagnostics.
Source : Tridan/CBS group
WEB SITE: Www.tridancbs.com
SOURCE Tridan/CBS group
Media contacts for interviews in English or in French: Lamia Charlebois, Public Relations Consultant, [email protected], 514 581 5831; Lionel Haddad, Engineer, Microbiologist, VP - Chief Scientific Officer at Tridan/CBS group, [email protected], 438 725-6575
Share this article