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The SARS-CoV-2 antigen self-test nose can prepare the results within 15 minutes, which improves Canada's testing capabilities for infection detection and outbreak control.

The SARS-CoV-2 antigen self-test nasal cavity enables individual 1 to conduct self-test quickly and conveniently at home using a short nasal swab to facilitate sampling.

This nasal test is suitable for self-use with symptoms and asymptomatics, and can provide reliable results within 15 minutes to make informed decisions, including rapid isolation.

According to local public health testing guidelines, the test will be provided to individuals in a pack of five tests through multiple locations.

The test uses pre-filled tubes to achieve simple and safe handling, thereby reducing handling errors and waste. In addition, the inactivation of the virus by the extraction buffer increases the protection for the user.

Laval, QC, December 13, 2021/CNW Telbec/-Roche Diagnostics, a division of Hoffmann-La Roche Limited in Laval, Quebec, proudly announces an important step in the fight against the pandemic: SARS-CoV- 2 Antigen Self Test Nasal has been approved under an interim order from Health Canada. Under an exclusive global distribution agreement with SD Biosensor Inc., this new rapid test is commercialized by Roche. It can be carried out at home and in a gathering environment, providing a new option for decentralized testing for Canada's provincial and territorial health care systems.

"The approval of this home test is an important development in Canada's response to COVID-19, because testing is still essential to prevent its spread." said Peter Geimer, Roche Diagnostics National Healthcare Director-Point of Care. With the reopening of the Canadian economy and the relaxation of hygiene measures for some outdoor and indoor activities, such as the ability to gather masses at festivals and events, rapid self-testing will enable rapid decision-making and rapid quarantine, thereby reducing the risk of further spread of the virus. ''

The SARS-CoV-2 antigen self-test nose collects samples from the front area of ​​the nose, thus simplifying and rapid testing procedures. 2 Following simple instructions, individuals can use nasal swabs at home or in suitable places for testing without special training or medical supervision. The test can provide results in as little as 15 minutes and can help people easily check whether they may be infectious in the comfort of their homes.

"Thanks to our high-quality and reliable SARS-CoV-2 antigen self-test nose, Canadians now have the right to make safer decisions to protect themselves and others. Because the test is easy to carry and use, it can be performed anytime, anywhere Michele D'Elia, executive director of Roche Diagnostics' Medical and Scientific Affairs Department, stated that this is necessary to ensure that appropriate measures are taken in the event of a positive result. The test provides additional tools for existing screening methods and helps Because the equipment is not available in the laboratory, rapid results are required, such as nursing homes, universities and other educational places and other gathering places. From the perspective of economic recovery, rapid detection can play an important role and help reduce the risk of workplace outbreaks. Ensure the stability and operation of its business."

The main use case for the self-test SARS-CoV-2 antigen self-test nasal cavity allows frequent testing of people at risk of exposure without the need to see a healthcare professional first. It also helps protect others, because quick results can make people more confident in returning to normal life activities. Quick self-inspection verification can ensure and contextualize minor symptoms after potential exposure. According to local public health guidelines, the screening tool can be used to provide access to certain locations using rapid test results. 3

In addition to diagnostic tests, preventive measures are still the key to combating SARS-CoV-2. It is recommended to continue to wear masks, maintain social distancing and maintain good hygiene habits. Roche Diagnostics commends the efforts of healthcare providers and frontline staff in communities across Canada.

About SARS-CoV-2 antigen self-test nose, used for self-test of family patients

SARS-CoV-2 rapid antigen self-test nose is a rapid chromatographic immunoassay (lateral flow assay) used to detect 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 SARS-CoV-2 antigen self-test nose is 91.2% (Ct≤30); in three different studies, it was 94.9% and 100%. The overall relative specificities of the three studies were 100%, 100%, and 98.4%, respectively, representing the ability of the test to correctly identify virus-free patients4. In a relatively independent self-test study, patients self-sampling, testing, and reading the results according to written and illustrated instructions. Most study participants found these procedures easy to perform. 5

The antigen test can detect proteins, which are the structural or functional components of the pathogen and therefore are very specific to the pathogen. 6 In this case, the test will provide a qualitative “yes/no” answer regarding the presence of the pathogen in the sample. If there is a sufficient concentration of the target antigen in the sample, it will bind to the specific antibody and produce a visually detectable result on the test strip Signal, usually results can be obtained within 15 minutes. Rapid antigen testing can reliably detect individuals with high viral loads, thereby quickly identifying those patients who are most at risk of spreading infection. 7

About Roche's response to the COVID-19 pandemic

As a leading healthcare company, we are committed to minimizing the impact of COVID-19 and helping to save and improve lives. Roche's measures to fight the epidemic include:

Initiate COVID-19 diagnostic tests to detect active infections and detect antibodies in patients who have been exposed to the virus.

Investigate the treatments in our existing product portfolio to better understand their potential to treat COVID-19 patients.

In the context of broader COVID-19 treatment, improve manufacturing and supply chain capabilities to meet product demand in our product portfolio.

Ensure that our existing drugs and diagnostic tools are provided to patients under special circumstances.

Roche is a global pioneer in the field of pharmaceuticals and diagnostics, committed to promoting scientific progress to improve people's lives. The combined advantages of pharmaceuticals and diagnostics, as well as growing data-driven medical insights, help Roche provide truly personalized healthcare. Roche is the world's largest biotechnology company with truly differentiated drugs in the fields of oncology, immunology, infectious diseases, ophthalmology and central nervous system diseases. Roche is also a world leader in in vitro diagnostics and tissue-based cancer diagnosis, and a leader in diabetes management. Founded in 1931, Roche Canada has more than 1,800 employees nationwide through its pharmaceutical division in Mississauga, Ontario, and the diagnostic and diabetes care division in Laval, Quebec.

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

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

The SARS-CoV-2 antigen self-test nose is suitable for personal use by individuals 16 years of age and above. The test must not be used by children under 16 years of age, and it must not be used by non-professionals to test other people. "

Quick reference guide, SARS-CoV-2 rapid antigen self-test nose. https://www.rochecanada.com/en/products/diagnostics-products/documentation/sars-cov-2-rapid-antigen-test-nasal-patient-self-test.html

People who have a positive SARS-CoV-2 nasal cavity antigen self-test should seek follow-up care from their doctor or healthcare provider, as additional testing and public health reports may be required. A positive result does not exclude bacterial infection or co-infection with other viruses. People who test negative and continue to show symptoms of COVID-19 (such as fever, cough, and/or shortness of breath) may still be infected with SARS-CoV-2 and should seek follow-up care from a doctor or healthcare provider. All test results will be reported to healthcare providers and relevant public health authorities in accordance with local, provincial and federal requirements.

SARS CoV-2 antigen self-test instructions for use in Canada. https://www.rochecanada.com/en/products/diagnostics-products/documentation/sars-cov-2-rapid-antigen-test-nasal-patient-self-test.html

Lindner AK, Nicolas O, Rohart C, etc. (2021). DOI: https://doi.org/10.1101/2021.01.06.20249009

European Center for Disease Control and Prevention. SARS-CoV-2 diagnostic test and screening. 2020 year

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

View original content and download multimedia: http://www.newswire.ca/en/releases/archive/December2021/13/c0409.html

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