Roche obtains CE mark for the SARS-CoV-2 Antigen Self Test Nasal allowing for rapid self testing of COVID-19 at home
Christian Fernsby ▼ | June 8, 2021
Roche has received CE mark for its SARS-CoV-2 Antigen Self Test Nasal for at-home testing.Article continues below
Topics: ROCHE
The test will be available in countries accepting the CE mark through pharmacies and other locations, in packs of five tests.
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.
With the CE Mark, the SARS-CoV-2 Antigen Self Test Nasal for rapid self testing of COVID-19 test has received official approval following the traditional registration pathway and can now also be used in markets that have not established regulatory exemption pathways.
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.
Complementary to the SARS-CoV-2 Antigen Self Test Nasal, Roche is offering NAVIFY Pass. This digital solution allows individuals and healthcare professionals to remotely store, display, and share their COVID-19 test results and vaccine status through a personalised 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 locations with COVID-19 entry protocols, such as restaurants or entertainment venues, as well as to validate safety to travel.
This test is part of a partnership with SD Biosensor Inc., with whom Roche has also launched a SARS-CoV-2 Rapid Antibody Test in July 2020 and two SARS-CoV-2 Rapid Antigen Tests for professional use in September 2020 and February 2021. ■ What to read next
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