The SARS-CoV-2 antigen self-test nasal enables users to share results and vaccine status on the company’s digital NAVIFY Pass solution
Roche has received CE mark approval for its SARS-CoV-2 Antigen Self Test Nasal, which facilitates rapid Covid-19 self-testing at home using a nasal swab.
The company is providing an early version of the test since February this year, for at-home use in several European markets, under local special approval pathways.
With the CE Mark, the test has received official approval and can be used in markets that have not established regulatory exemption pathways.
Users can perform the test at home using a nasal swab without special training or the supervision of a healthcare worker, and get the test results within 15 minutes.
Roche Diagnostics CEO Thomas Schinecker said: “As the world prepares to reopen, high-quality, home-based testing will play an important role in the battle against the pandemic.
“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.”
Roche developed the test under a partnership with SD Biosensor and intends to market the test in countries accepting the CE mark through pharmacies and other locations.
The clinical performance of the test was evaluated by head-to-head comparison with the company’s RT-PCR test using nasopharyngeal swab specimens as a comparator.
According to combined study data, the SARS-CoV-2 Antigen Self Test Nasal showed a 91.1% relative sensitivity and 99.6 % overall relative specificity in detecting SARS-CoV-2.
Together with the test, Roche is offering NAVIFY Pass, a digital solution that allows remote storage, display, and sharing of Covid-19 test results and vaccine status through a personalised QR code.
With easy access to test results and vaccination status, individuals and companies can easily access locations with Covid-19 entry protocols, said the company.
In March this year, the Swiss healthcare firm has agreed to acquire multiplex molecular diagnostic solutions provider GenMark Diagnostics for $ 1.8bn.