Lumivi DiagnosticsTM LP announces authorization of COVID-19 rapid antibody test kit
Posted by Lumivi Diagnostics on
Toronto, Ontario (June 17, 2021) – Lumivi Diagnostics LP today announced it has received Health Canada authorization for its Canadian-made SARS-CoV-2 IgG Rapid Test. The test kits will be available for use by medical professionals as an additional resource in their comprehensive COVID-19 testing protocols.
Lumivi Diagnostics is a Canadian joint venture between Immune Response Diagnostics Inc., an affiliate of International Point of Care and Suncor Energy that formed in July 2020 to further develop, gain regulatory approval, and manufacture medical devices to support Canada’s ongoing COVID-19 response.
Lumivi’s SARS-CoV-2 IgG Rapid Test assesses if a person has had prior exposure to COVID-19 and their body’s defense system has produced antibodies in response. While medical understanding about antibodies and individual immunity is still evolving, many believe there is value in having access to quick, inexpensive and reliable antibody testing in Canada.
“Antibody testing could play a significant role in the country’s integrated pandemic response as an additional layer of protection to keep Canadians safe,” said Ian Klarer, of Lumivi Diagnostics. “Having more data on immunity will help public health authorities make informed, data-based decisions when it comes to safely re-opening our economies, supporting effective vaccine programs, and protecting Canadians in their workplaces.”
The single use Lumivi Diagnostics SARS-CoV-2 IgG Rapid Test provides results within 15 minutes and is intended for use by laboratory personnel or other healthcare professionals. The test is highly accurate with a sensitivity and specificity greater than 98%.
The test kit is now available for purchase by healthcare professionals in support of their comprehensive COVID-19 testing protocols with delivery expected in mid-July. The SARS-CoV-2 IgG Rapid Test has been authorized by Health Canada under the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.
About the Lumivi Diagnostics SARS-CoV-2 IgG Rapid Antibody Test
- Detects IgG antibodies to the virus in plasma and serum
- Results in 15 minutes
- Made in Canada
- Single use
- Greater than 98% sensitivity and specificity
- No analyzer required
- Identifies an adaptive immune response, which indicates recent or prior infection
- Administered by laboratory personnel or other healthcare professionals
- For laboratory use only, not for point-of-care use at this point in time
A sell sheet accompanying this announcement is available under the Products section at: www.lumivi.com.
Lumivi Diagnostics LP is a joint venture between Immune Response Diagnostics Inc., an affiliate of International Point of Care and Suncor. Lumivi Diagnostics LP develops, manufactures, markets and sells the Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Antibody Test Kit to the Canadian market.
Suncor Energy is Canada's leading integrated energy company, with a global team of over 30,000 people. Suncor's operations include oil sands development, production and upgrading, offshore oil and gas, petroleum refining in Canada and the US, and our national Petro-Canada retail distribution network (now including our Electric Highway network of fast-charging EV stations). A member of Dow Jones Sustainability indexes, FTSE4Good and CDP, Suncor is responsibly developing petroleum resources, while profitably growing a renewable energy portfolio and advancing the transition to a low-emissions future. Suncor is listed on the UN Global Compact 100 stock index. Suncor's common shares (symbol: SU) are listed on the Toronto and New York stock exchanges.
Immune Response Diagnostics (IRD) is an Ontario Corporation created by the IPOC Management group and Investors to facilitate the partnership and financial resources needed to complete the research, development, regulatory and manufacturing activities required to bring the Lumivi Diagnostics’ SARS CoV-2 IgG Rapid Test Kit to market.
International Point of Care (IPOC) is a Canadian corporation headquartered in Toronto. IPOC has been a leader in rapid, Point of Care, Lateral Flow test development and manufacturing in the Medical Diagnostic industry for the last 13 years. IPOC and its partner’s products include rapid testing solutions for the Cardiac, Kidney Injury, Womens’ health, Coagulation monitoring and infectious disease (including COVID) segments of the human medical diagnostic markets as well as a novel food safety testing platform used by food producers to confirm pathogen free food production facilities world-wide.
For more information about Lumivi, visit the website at www.lumivi.com.
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