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Roche’s COVID-19 Rapid Tests Gain CE Marks

October 17, 2022

Three of Roche’s COVID-19 tests have received Europe’s CE mark certification — the SARS-CoV-2 Rapid Antigen Test 2.0, the SARS-CoV-2 Rapid Antigen Test 2.0 Nasal and the SARS-CoV-2 Antigen Self Test Nasal.

All three tests feature new digital data sharing capabilities with results delivered in as few as 15 minutes. The tests can be used with Roche’s navify Pass software that allows individuals and healthcare professionals to share COVID-19 vaccination status and test results.

The SARS-CoV-2 Rapid Antigen Test 2.0 uses samples from deep inside the nasopharyngeal passage while the other tests use samples taken at least half and inch inside the nose. All three tests can detect major variants of concern including Delta and Omicron.

The company plans to begin European distribution of the new rapid tests in the coming weeks.

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