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Roche received the CE mark for its SARS-CoV-2 nasal antigen test for home testing. The test will be available in countries that accept the CE mark through pharmacies and other locations, in packs of five tests.
A first version of the test is already available as a home test in numerous European markets as part of local special approval pathways from February 2021. CE-marked, SARS-CoV-2 nasal self-test for rapid self-test of the COVID-19 test has received official approval following the traditional registration path and can now also be used in markets that have not established regulatory exemption paths.
Individuals can perform the test at home using a nasal swab without specific training or the supervision of a healthcare professional. The test provides results in as little as 15 minutes and can help people check if they are likely to be infectious from home. In the case of children under the age of 18, the test should be performed by an adult or under the close supervision of an adult.
As companies begin to reopen and in line with local health regulations, the test allows people planning to attend an event or gathering to use the test as a tool to confirm that they are not likely to carry a substantial amount of the virus, thus helping make informed decisions and reduce the risk of transmission to others.
Complementary to the nasal SARS-CoV-2 Antigen Autotest, Roche offers NAVIFY Pass. This digital solution allows individuals and healthcare professionals to remotely store, view and share COVID-19 test results and vaccine status via a customized QR code. Having easy digital access to test results and vaccination status could potentially be used by both individuals and companies to facilitate access to places with COVID-19 entry protocols, such as restaurants or entertainment venues, as well as to validate the safety to travel.
Thomas Schinecker, CEO of Roche Diagnostics, said: As the world prepares to reopen, high-quality home testing will play an important role in the battle against the pandemic. Regular self-diagnosis at home can reduce the pressure on health systems. It can quickly identify people with the highest potential to be infectious so they can take immediate action to see a doctor, manage their infection, and protect others.
This test is part of a partnership with SD Biosensor, with which Roche also launched a SARS-CoV-2 rapid antibody test in July 2020 and two SARS-CoV-2 antigen rapid tests for professional use in September 2020 and February. 2021.
Geoff Twist, general manager of Roche Diagnostics UK and Ireland, said: “As we navigate the road to recovery from this pandemic, thorough testing for COVID-19 will continue to play a vital role in enabling normal business to resume safely. and with confidence.
“Our new nasal antigen self-test delivers results in as little as 15 minutes and has the added benefit of requiring only one sample from the underside of both nostrils, making it relatively easy and less inconvenient to perform. It is also supported by a digital solution. which allows individuals and healthcare professionals to securely store and view COVID-19 test results.
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