Roche’s SARS-CoV-2 Antigen Test Receives CE mark For Self Testing of COVID-19 at Home

June 8, 2021 Auto Bot CE Mark, MedTech, regulatory, Roche 0

Shots:

  • Roche received a CE mark for its SARS-CoV-2 Ag self-test nasal at home setting for COVID 19. The test will be available in countries accepting the CE mark
  • The early version of the test is available in the EU under special approval pathways since Feb, 2021. The test can be performed by individuals using nasal swap & can deliver results in 15mins
  • The test demonstrates 91.1% relative sensitivity and 99.6 % overall relative specificity from the combined study. Additionally, Roche offers NAVIFY Pass digital solution that enables individuals to share their test results and vaccine status through a unique QR code

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