The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Roche’s COVID-19 At-Home Test.
A rapid chromatographic immunoassay, the Covid-19 test is designed to detect nucleocapsid protein of SARS-CoV-2.
Using anterior nasal swab samples, the test provides accurate results in 20 minutes for SARS-CoV-2 as well as all known Covid-19 variants, including the latest Omicron.
The samples can be self-collected and tested by individuals aged 14 years and above, and by adults for children aged between two and 13 years.
The company stated that in prospective clinical study, the at-home test kit demonstrated 100% relative specificity and 95.3% relative sensitivity.
The EUA has been granted through the company’s participation in Rapid Acceleration of Diagnostics (RADx) Independent Test Assessment Program (ITAP) of the National Institutes of Health (NIH). Through this programme, NIH aims to bring rapid tests to the over the counter (OTC) market.
Roche Diagnostics CEO Thomas Schinecker said: “The Covid-19 pandemic continues to shed light on the critically important role that rapid self-testing plays in empowering individuals to protect their personal health and the health of their families and communities.
“At this inflection point in the American public’s fight against Covid-19, we are proud to have worked in close collaboration with the US Government to introduce and expand access to accurate, reliable and high-quality at-home tests.”
The new at-home test will become available for purchase at pharmacies and retailers across the US from January 2022.
The company has a global distribution agreement with SD Biosensor, which has also been previously involved in the launch of a range of Covid-19 tests.
Roche claimed that it has capability to produce ‘tens of millions’ of its Covid-19at-home tests per month at the time of launch in the US.
Roche also intends to provide NAVIFY Pass to organisations along with its COVID-19 At-Home Test to enable people to store, display, and share the test results remotely.
Recently, the company obtained CE mark for the use of saliva samples with its cobas SARS-CoV-2 Qualitative test to detect SARS-CoV-2.