- The SARS-CoV-2 Antigen Self Test Nasal enables individuals to quickly and conveniently test themselves for COVID-19 at home using a simple nasal swab
- An early version of the test has already been available as a home-test in a number of European markets under local special approval pathways since
February 2021 - The test will be widely available to individuals through pharmacies and other locations in accordance to local guidelines and testing strategies
- The test works seamlessly with NAVIFY® Pass, Roche’s digital solution that allows individuals and healthcare providers to immediately store, display, and share their COVID-19 test results and vaccine status through a unique QR code
An early version of the test has already been available as a home-test in a number of European markets under local special approval pathways since
By following simple instructions, individuals can perform the test at home 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. In the case of children under 18 years of age, the test must be performed by an adult or under close adult supervision.
As societies begin to reopen and in line with local health regulations, the convenient test allows individuals planning to attend an event or gathering to use the test as a tool to confirm that they are not likely to be carriers of a substantial amount of the virus thus helping them make informed decisions and reduce the risk of transmission to others.
Complementary to the SARS-CoV-2 Antigen Self Test Nasal,
“As the world prepares to reopen, high-quality, home-based testing will play an important role in the battle against the pandemic,” said Thomas Schinecker, CEO,
This test is part of a partnership with SD Biosensor Inc., with whom
In addition to diagnostic testing, preventive measures remain key to protecting yourself and others against SARS-CoV-2. It is recommended to continue wearing masks, socially distance and practice good hygiene, especially if you have symptoms or known contact with others
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. Each test contains a unique QR code to enable individuals to share their test results and vaccine status using
The clinical performance of the test was measured by head to head comparison with Roche’s highly sensitive reverse transcriptase polymerase chain reaction (RT-PCR) test using nasopharyngeal swab samples as a comparator, the gold standard sampling and detection method for SARS-CoV-2 detection.1,2 Combined study results showed that the relative sensitivity of the SARS-CoV-2 Antigen Self Test Nasal was 91.1%.** The overall relative specificity was 99.6 %,3 which represents the ability of the test to correctly identify patients without the virus. In one comparative independent self testing study where patients followed written and illustrated instructions to sample, test and read-out the results themselves, the majority of study participants considered the procedures easy to perform.4
About antigen testing
An antigen test detects proteins which are structural or functional components of a pathogen and are very specific to that pathogen.5 In this case, the test would provide a qualitative “yes/no” answer on the presence of the antigen 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 (nucleocapsid protein) 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 the greatest risk of spreading the infection.6
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 in-vitro diagnostic company focused on the development of immunoassay and molecular diagnostic products at the POC. Founded in 2010, SD Biosensor has continued to research and develop products that can aid in the fast and accurate diagnosis of patients across the testing journey. Through these innovative products, they are striving to become a leading global in vitro diagnostics 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 capacity for all Roche SARS-CoV-2 rapid antigen tests
** Combined study results include three cohorts: professional, self collected and self testing.
References
[1] Péré H, Podglajen I, Wack M et al. (2020). J of Clin Microbiol 58, e00721-20
[2] Kevadiya BD, Machhi J, Herskovitz J et al. (2021).
[3] SD Biosensor. (2021). SARS-CoV-2 Antigen Self Test Nasal package insert
[4] Lindner AK, Nikolai O, Rohardt C et al. (2021). DOI: https://doi.org/10.1101/2021.01.06.20249009
[5]
[6] Cerutti, Krüger,
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Attachment
- 08062021_MR_ CE Mark for Rapid Antigen Self Test Nasal_ EN
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