SARS-CoV-2 Antigen Self Test Nasal receives CE mark
Roche has received CE marking for its SARS-CoV-2 Antigen Self Test Nasal for at-home testing. 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 SARS-CoV-2 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 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.