Roche’s SARS-CoV-2 Rapid Antigen Test approved under Health Canada’s Interim Order

With results ready in 15 minutes, the SARS-CoV-2 Rapid Antigen Test increases Canada’s testing capacity at the point of care.

• Antigen test reliably and quickly triages people suspected of COVID-19*, with results ready in 15 minutes, allowing informed decisions including rapid isolation

• The test has a sensitivity of 86.2%-90.0% and a specificity of 97.9%-99.3%, based on 1,106  samples collected from patients* from two independent study centers  

• The instrument-free testing kit enables convenient use and a seamless workflow for healthcare professionals at different point of care locations or in resource-limited settings

Laval (Quebec), February 16, 2021 - Subsequent to its global distribution agreement with SD Biosensor Inc, Roche Diagnostics, a division of Hoffmann-La Roche Limited, announces that its SARS-CoV-2 Rapid Antigen Test has received approval under Health Canada's Interim Order. This can help healthcare professionals identify a SARS-CoV-2 infection with results typically ready in 15 minutes. 

“Roche’s SARS-CoV-2 Rapid Antigen Test allows taking the test to the patient while enabling fast decision making and rapid isolation, thus reducing the risk of further spreading the virus, said François Drolet, Director, Public Affairs at Roche Diagnostics. Our SARS-CoV-2 Rapid Antigen Test is an additional tool in the toolbox which offers opportunities to refine the COVID-19 testing strategies while the country looks at safely reopening the economy and keeping Canadians safe.”

“The SARS-CoV-2 Rapid Antigen Test detects the presence of the SARS-CoV-2 virus by identifying the  virus nucleocapsid protein while large quantities are present in the respiratory tract, said Michele D’Elia, Director, Medical Affairs at Roche Diagnostics. The test is optimized to detect infections in individuals with an onset of clinical symptoms of 5 days or less. ” 

Building on Roche’s consistent and reliable supply chain since the beginning of the pandemic, and with hundreds of millions tests distributed worldwide in partnership with SD Biosensor Inc, the company will now start distributing in Canada the Roche SARS-CoV-2 Rapid Antigen Test with tens of millions of tests having been dedicated to the country.

COVID-19 testing solutions that provide healthcare professionals and patients with a quick answer regarding their infection status are critical to contain the community-spread of the COVID-19 virus. Roche’s SARS-CoV-2 Rapid Antigen Test is a new addition to the comprehensive Roche diagnostic portfolio to help healthcare systems combat COVID-19 through testing in the laboratory and at the point of care. 

Roche’s SARS-CoV-2 Rapid Antigen Test is a rapid chromatographic immunoassay intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in human nasopharynx. This test is performed by healthcare professionals using a nasopharyngeal swab collected from a patient.2 The results are intended to aid in the early diagnosis of SARS-CoV-2 infection in individuals suspected of COVID-19 within the first 5 days of the onset of symptoms. The test has a sensitivity of 86.2%-90.0% and a specificity of 97.9%-99.3%, based on 1,106  samples collected from patients with an onset of clinical symptoms of ≤5 days, from two independent study centers1. Results are ready in only 15 minutes.2

An antigen test detects proteins which are structural or functional components of a pathogen and are thus very specific to that pathogen.3  In this case, the test would provide a qualitative “yes/no” answer on the presence of the pathogen in the patient sample. If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a positive result, indicating an active infection4.  In general, antigen tests have a high specificity, though are not as sensitive as PCR tests that amplify the target viral DNA or RNA sequence in order to generate a quantifiable signal to indicate the presence of the virus in a sample. Therefore, to make up for the potential decrease in sensitivity of an antigen test, negative results should be considered together with additional patient factors, such as COVID-19 exposure history, clinical symptoms and additional test results.

As a leading healthcare company we are committed to support countries in minimizing the impact of COVID-19.  We have developed a growing number of diagnostic solutions that help to detect and diagnose  the infection in patients, as well as providing digital support to healthcare systems, and we continue to identify, develop and support potential therapies which can play a role in treating the disease.

We understand the impact of COVID-19 goes beyond those who contract it, which is why we are working with public health authorities, institutions, laboratories and healthcare providers to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times. As we learn from the pandemic, we are partnering with governments and other stakeholders to make healthcare stronger and more sustainable in the future.

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 under one roof have made Roche the leader in personalized healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. 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. For more information, please visit

Marie-Élaine Guay
Roche Diagnostics Canada                   
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*within the first 5 days of the onset of symptoms

References:

1. Evaluation was carried out in study centers in Germany and Brazil.

2. SD Biosensor. (2020). SARS-CoV-2 Rapid Antibody Test package insert 

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