- The SARS-CoV-2 Rapid Antigen Test Nasal uses a nasal swab to quickly and conveniently collect specimens from people suspected of having an active infection
- The easy-to-use test optimizes workflow and does not require an instrument or any preparation
- Nasal sampling allows for collection of the sample from the front area of the nose resulting in a less invasive testing experience by reducing overall patient discomfort, particularly in sensitive individuals such as children
- Antigen test reliably and quickly identifies people suspected of COVID-19*, with results ready in 15 minutes, allowing informed decisions including rapid isolation
- The SARS-CoV-2 Rapid Antigen Test Nasal is intended for use by healthcare professionals, or for self-collection under the supervision of a healthcare professional.
In comparison to the existing Roche SARS-CoV-2 Rapid Antigen Test already available in
"We are very proud of this announcement that showcases once again our commitment in the fight against COVID-19. While we can only commend the progress made by many jurisdictions in making rapid tests widely available, we remain convinced that the country has not yet leveraged their full potential, said
"While vaccination rates continue to improve,
Additionally,
Did you know?
In
Furthermore, the Industry Advisory Roundtable on COVID-19 Testing, Screening, Tracing and Data Management released a report4 that reiterates the importance of using rapid tests in workplace settings since rapid detection helps with the quick isolation of positive COVID-19 cases to keep the rest of the workplace safe and support economic recovery.
Rapid testing is also supported by Medtech Canada and members of the industry including Roche Diagnostics Canada in a position paper that highlights a series of recommendations calling for comprehensive testing strategies in
"The perfect test does not exist, nor does the perfect strategy, but rapid antigen tests are optimal for large scale testing since they are easy to use by a wide range of healthcare professionals and can be brought directly to the public in order to reduce the propagation of the virus" said
The SARS-CoV-2 Rapid Antigen Test Nasal is the latest addition to
About
As a leading healthcare company, we are committed to minimize the impact of COVID-19 and help save and improve lives.
- 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 the SARS-CoV-2 Rapid Antigen Test Nasal
The SARS-CoV-2 Rapid Antigen Test Nasal is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 present in human nasal specimens. In clinical studies, the SARS-CoV-2 Rapid Antigen Test Nasal showed a relative sensitivity of 89.6% (Ct value ≤ 30; 95% CI: 79.7% - 95.7%) and a specificity of 99.1% for professionally collected samples. For self-collected samples** a sensitivity of 89.1% (Ct value ≤ 30; 95% CI: 78.8% - 95.5%) and a specificity of 99.0% was detected. Overall, the studies contained 696 symptomatic and asymptomatic individuals.5 This test is intended to detect antigen from SARS–CoV–2 in individuals suspected of COVID–19 with clinical symptoms onset within 5 days.
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 patient sample and can be offered as a rapid strip test that is performed at the point of care. 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 healthcare professionals to quickly identify those patients at greatest risk of spreading the infection.7
About
About SD Biosensor
SD Biosensor is a global bio-diagnostic company that provides in vitro products engrafted with innovative technologies. Established in 2010, SD Biosensor has successfully launched diagnostics of blood glucose, glycated hemoglobin and cholesterols globally. Through these innovative products, they are striving to become a leading global in vitro diagnostic company. For more information, please visit www.sdbiosensor.com.
References
[1] OASH Nasal Specimen Collection Fact Sheet - Updates 2020-11-11 |
[2] https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/testing-screening-advisory-panel/reports-summaries/priority-strategies.html#a9 |
[3] https://advances.sciencemag.org/content/7/1/eabd5393 |
[4] https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/testing-outreach-collaboration/industry-advisory-roundtable/reports/task-shifting-self-administration-workplace-screening-programs.html#a2 |
[5] SD Biosensor. (2021). SARS-CoV-2 Rapid Antigen Test Nasal Canadian package insert |
[6] |
[7] Cerutti, Krüger, |
*Within the first 5 days of the onset of symptoms. |
**Done under the supervision of a healthcare professional |
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SOURCE Roche Diagnostics Canada
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