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Reliable COVID-19 Rapid Testing at Home: Roche's SARS-CoV-2 Antigen Self Test Nasal Approved Under Health Canada's Interim Order

LAVAL, QC, Dec. 13, 2021 /CNW Telbec/ - Roche Diagnostics, division of Hoffmann-La Roche Limited, based in Laval, Quebec, is proud to announce an important step forward in the fight against the pandemic: The SARS-CoV-2 Antigen Self Test Nasal has received approval under Health Canada's Interim Order. This new rapid test is commercialized by Roche under an exclusive Global distribution agreement with SD Biosensor Inc. It can be performed at home and congregate settings providing Canada's provincial and territorial health care systems with a new option for decentralized testing.

"The approval of this at-home test is an important advance in Canada's answer to COVID-19 as testing remains crucial to preventing its spread." said Peter Geimer, National Healthcare Director - Point of Care at Roche Diagnostics. With the reopening of Canada's economy and the relaxation of some sanitary measures for outdoor and indoor activities such as the capacity for mass gatherings including festivals and events, rapid self testing would enable fast decision-making and rapid isolation, thus reducing the risk of further spreading the virus.''

The SARS-CoV-2 Antigen Self Test Nasal collects the sample from the front area of the nose resulting in a simplified and faster testing procedure.2 By following simple instructions, individuals can perform the test at home or a suitable place using a nasal swab without special training or the supervision of a healthcare worker. The test provides results in as little as 15 minutes and can help people to conveniently check if they are likely to be infectious from the comfort of their home.

"Thanks to our high-quality and reliable SARS-CoV-2 Antigen Self Test Nasal, Canadians are now empowered to make safer decisions to protect themselves and others. Since this test is easy to carry and use, it can be performed whenever and wherever needed, ensuring appropriate measures are taken in case of a positive result, said Michele D'Elia, Executive Director, Medical and Scientific Affairs at Roche Diagnostics. This test offers an additional tool to current screening methodologies already in place and facilitates testing in places where laboratory instruments are not available and quick results are needed, such as nursing homes, educational settings like universities and other congregate settings. From an economic recovery perspective, rapid testing can play an important role by helping to reduce the risk of outbreaks at workplaces and thus ensure the stability and functioning of their operations."

The main use cases of the self-test
The SARS-CoV-2 Antigen Self-Test Nasal allows frequent testing for those at risk of exposure without having to see a healthcare professional first. It also helps protect others as fast results offer more confidence about returning to normal life activities. Quick self-test verification reassures and contextualizes minor symptoms after potential exposure. According to local public health guidelines, this screening tool could be used to provide access to certain locations using rapid test results.3 

In addition to diagnostic testing, preventive measures remain key for protection against SARS-CoV-2. It is recommended to continue wearing masks, socially distance and practice good hygiene. Roche Diagnostics praises the efforts of healthcare providers and frontline workers in communities all around Canada.

About the SARS-CoV-2 Antigen Self Test Nasal for at-home patient self-testing

The SARS-CoV-2 Rapid Antigen Self Test Nasal is a rapid chromatographic immunoassay (lateral flow assay) for the detection of the nucleocapsid protein of SARS-CoV-2 in human nasal samples.

The clinical performance of the test was measured in three clinical studies. The overall relative sensitivity of the SARS-CoV-2 Antigen Self Test Nasal was 91.2% (Ct ≤ 30); 94.9% and 100% in the three different studies. The overall relative specificity was 100%, 100% and 98.4% in the three studies, which represents the ability of the test to correctly identify patients without the virus4. In one comparative independent self-testing study where patients followed written and illustrated instructions to sample, test and read-out the results themselves, a majority of study participants considered the procedures easy to perform.5

About antigen testing

An antigen test detects proteins, which are structural or functional components of a pathogen and are thus very specific to that pathogen.6 In this case, the test would provide a qualitative "yes/no" answer on the presence of the pathogen in the sample. If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a visually detectable signal on the test strip, typically with results ready in 15 minutes. A rapid antigen test can reliably detect individuals with a high viral load allowing to quickly identifying those patients at greatest risk of spreading the infection.7

About Roche's response to the COVID-19 pandemic

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.

About Roche

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, as well as growing capabilities in data-driven medical insights, help Roche deliver truly personalized healthcare. 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. Roche Canada was founded in 1931 and employs more than 1,800 people across the country through its Pharmaceuticals division in Mississauga, Ontario as well as its Diagnostics and Diabetes Care divisions in Laval, Quebec.

For more information, please visit www.RocheCanada.com and follow us on Twitter @RocheCanada.

All trademarks used or mentioned in this release are protected by law.

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1

The SARS-CoV-2 Antigen Self Test Nasal is intended for self-use in individuals aged 16 and older. The test may not be used in children younger than 16 or by lay users to test others."

2

Quick Reference Guide, SARS-CoV-2 Rapid Antigen Self-Test Nasal. https://www.rochecanada.com/en/products/diagnostics-products/documentation/sars-cov-2-rapid-antigen-test-nasal-patient-self-test.html

3

Persons who test positive with the SARS-CoV-2 Antigen Self Test Nasal should seek follow-up care with their physician or health care provider as additional testing and public health reporting may be necessary. Positive results do not rule out bacterial infection or co-infection with other viruses. Persons who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow-up care with their physician or health care provider. All test results will be reported to health care providers and relevant public health authorities in accordance with local, provincial and federal requirements.

4

SARS CoV-2 Antigen Self Test Canadian Instructions For Use. https://www.rochecanada.com/en/products/diagnostics-products/documentation/sars-cov-2-rapid-antigen-test-nasal-patient-self-test.html

5

Lindner AK, Nikolai O, Rohardt C et al. (2021). DOI: https://doi.org/10.1101/2021.01.06.20249009

6

European Centre for Disease Prevention and Control. Diagnostic testing and screening for SARS-CoV-2. 2020

7

Cerutti, Krüger, van Beek, Igloi, Krüttgen, Salvagno

SOURCE Roche Diagnostics Canada

For further information: Marie-Élaine Guay, Roche Diagnostics Canada, E: [email protected]