Ce approval (European conformity) arrives for a new product from Roche, the Swiss pharmaceutical multinational. In particular, the European conformity mark was confirmed in relation to a self-test for the rapid detection of Covid-19 through the use of a nasal swab.
The new test will be based on Navify Pass, a digital solution developed by the pharmaceutical group that allows users and healthcare specialists to store, view and share test results and their vaccination status in real time via an individual QR code. The product is the result of the collaboration with Sd Biosensor, with which the Basel pharmaceutical group launched a rapid test to detect Sras-Cov-2 antibodies in July 2020 and two rapid antigen tests, for professional use, in September 2020 and in February of this year.
By following simple instructions, without specific training or the supervision of a healthcare professional, they can perform the test at home using a nasal swab and get the result in as little as 15 minutes. In the case of children under 18, the test must be performed by an adult or a minor supervised by an adult. The results of the combined study showed that the relative sensitivity of the nasal SARS-CoV-2 antigen self-test is 91.1%, the overall relative specificity (the ability of the test to correctly identify patients without the virus) is 99, 6%.
The test will be available in countries that accept the CE mark and will be marketed in pharmacies and other outlets in packs of five. A first version of the product is already available as a home-test, from February 2021, within some European markets in order to respond to special local approval paths. Thanks to the CE mark, a product can be marketed without restrictions within the European Union and the European Economic Area. According to the State Secretariat for Economic Affairs (Seco), the Ce mark is not required in Switzerland, however, if Swiss legislation requires a conformity mark, the Ce mark could be used instead of the Swiss mark.
“As the world prepares to reopen, home testing will play an important role in the battle against the pandemic,” said Thomas Schinecker, CEO of Roche Diagnostics, “regular self-diagnosis at home can reduce the pressure on health systems. It can. quickly identify people with the highest level of infection so that they can immediately see a doctor and manage their infection in the full protection of others. ” (All rights reserved)