Roche announced on Tuesday that the nasal swab version of its SARS-CoV-2 antigen self-test has received CE marking for home use.
The company said in a statement that users can perform self-tests at home using nasal swabs. The test will be available as a kit through pharmacies and other locations, subject to local guidelines. An earlier version of the test has been available as a home test in select European markets, including Germany, since February under a special approval pathway.This lateral flow test was developed in collaboration with the South Korean diagnostics company SD Biosensor, and provides results in approximately 15 minutes,It can also be performed without special training or supervision by healthcare professionals. Roche stated that for children under 18 years of age, the test must be performed by an adult or under close adult supervision. The test received CE marking for professional use in February.Compared with the Roche RT-PCR test, the relative sensitivity of this antigen test is 91%, and the relative specificity is close to 100%.Thomas Schinecker, CEO of Roche Diagnostics, said in a statement: "As the world prepares to reopen, high-quality at-home tests will play a crucial role in the fight against the pandemic."Roche and SD Biosensor previously launched a SARS-CoV-2 rapid antibody test and two SARS-CoV-2 rapid antigen tests for professional use.Roche also provides its Navify Pass digital solution., enabling users to store, display, and share their COVID-19 test results and vaccination status via personalized QR codes. | 
