Swiss multinational healthcare company Roche has secured CE mark approval for its SARS-CoV-2 Antigen Self Test Nasal for at-home testing.
The company will supply the packs of five tests in countries accepting the CE mark via pharmacies and other locations.
The SARS-CoV-2 Rapid Antigen Self Test Nasal is a rapid chromatographic immunoassay or lateral flow assay, which will help identify the nucleocapsid protein of SARS-CoV-2 in human nasal samples.
According to Roche, individuals will be able to perform the test at home using a nasal swab by following simple instructions. It does not need any special training or the supervision of a healthcare worker.
The test, which delivers results within 15 minutes, has to be performed by an adult or under close adult supervision for children under 18 years of age.
Roche is also offering NAVIFY Pass digital solution along with the SARS-CoV-2 Antigen Self Test Nasal.
To help patients share their test results and vaccine status using NAVIFY Pass, each test consists of a unique QR code.
The digital solution will enable individuals and healthcare professionals to remotely store, display, and share their Covid-19 test results and vaccine status via a personalised QR code.
Roche Diagnostics CEO Thomas Schinecker said: “Regular self-testing at home can reduce pressure on healthcare systems.
“It can quickly identify people with the highest potential to be infectious so they can take immediate action to seek medical advice, manage their infection and protect others.”
The Covid-19 antigen test is a result of a partnership between Roche and SD Biosensor.
The firms also introduced a SARS-CoV-2 rapid antibody test in July last year and two SARS-CoV-2 Rapid Antigen Tests for professional use in September same year and February this year.
