- 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
- Nasal sampling allows for collection of the sample from the front area of the nose instead of the nasopharynx resulting on a less invasive testing experience for patients
- The test also provides patients with the option to self-collect their nasal sample
In comparison to the existing Roche SARS-CoV-2 Rapid Antigen Test, the SARS-CoV-2 Rapid Antigen Test Nasal collects the sample from the front area of the nose instead of the nasopharynx, resulting in a simplified and faster testing procedure1. This testing method can help reduce overall patient discomfort, particularly in sensitive individuals such as children, elderly people and/or people with disabilities.
Besides being less invasive, the test also provides patients with the option to self-collect their nasal sample under the supervision of a healthcare professional. Through reduced physical contact, this method of testing can help to decrease the risk of exposure to the virus for healthcare professionals. Whether the test could also be used without supervision of a healthcare professional will depend on local regulatory requirements.
“Rapid testing continues to play an important role in the fight against COVID-19, especially in places when laboratory testing is not available and quick results are needed, such as nursing homes, healthcare facilities, and schools.” said Thomas Schinecker, CEO
The launch is a partnership with
The test is the latest addition to
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 90.6% (Ct value ≤ 30; 95 % CI: 75.0 % - 98.0 %) and a specificity of 98.6% for professionally collected samples. For self-collected samples a sensitivity of 84.4 % (Ct value ≤ 30; 95 % CI: 67.2 % - 94.7 %) and a specificity of 99.2% was detected. Overall the studies contained 468 symptomatic and asymptomatic individuals2. This test is intended to detect antigen from SARS‑CoV‑2 in individuals suspected of COVID‑19 or with known or suspected exposure to SARS‑CoV‑2.
This product is intended for professional use in laboratory and Point of Care environments, and/or self-collection under the close supervision of a healthcare worker.
About antigen testing
An antigen test detects proteins which are structural or functional components of a pathogen and are thus very specific to that pathogen3. 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.4
About Roche’s response to the COVID-19 pandemic
The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need. This new test is an additional step in Roche’s fight against the COVID-19 pandemic, which has already included:
- 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, and
- Ensuring the supply of our existing medicines and diagnostics to patients around the world under exceptional conditions.
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On
In these exceptional times,
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.
About
Founded in 1896,
The
All trademarks used or mentioned in this release are protected by law.
*Production capacities are combined for both the SARS-CoV-2 Rapid Antigen Test (nasopharyngeal) and the new SARS-CoV-2 Rapid Antigen Test Nasal
References
[1] OASH Nasal Specimen Collection Fact Sheet - Updates 2020-11-11
[2] SD Biosensor. (2020). SARS-CoV-2 Rapid Antigen Test Nasal package insert
[3]
[4] Cerutti, Krüger,
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