As the group announced on Tuesday, June 8th, it has received the so-called CE mark for the SARS-CoV-2 antigen self-test nasal. The CE mark stands for “European conformity”. Medical devices may only be placed on the market if they are provided with the CE mark. This marking ensures that products meet basic requirements.
The test from Roche, which is intended for use at home, is now available in all countries that accept a CE mark. An early version of the test has been available since February 2021 as a home test in a number of European markets as part of local special approval channels. The test has also been distributed free of charge in pharmacies in Switzerland since this spring.
Individuals can do the test at home with a nasal swab without the need for special training or supervision by medical staff. The test reportedly provides results in 15 minutes and can help people check whether they are possibly infectious from the comfort of their own home.
In addition to the SARS-CoV-2 antigen self-test nasal, Roche offers the NAVIFY pass. This digital solution enables individuals and healthcare professionals to remotely save, view and share their COVID-19 test results and vaccination status via a personalized QR code.