The rapid chromatographic immunoassay will facilitate the qualitative identification of a specific antigen of SARS-CoV-2 present in the human nasopharynx
Swiss healthcare company Roche is set to introduce a SARS-CoV-2 rapid antigen test in CE mark accepting countries by the end of this month.
The company is also planning to submit an application with the US Food and Drug Administration (FDA) to secure emergency use authorisation (EUA) for the rapid antigen test.
Roche’s SARS-CoV-2 rapid antigen test is a rapid chromatographic immunoassay, which will help in the qualitative identification of a specific antigen of SARS-CoV-2 present in human nasopharynx.
The nasopharyngeal swab collected from a patient will be used by healthcare professionals to conduct the test.
The SARS-CoV-2 rapid antigen test delivers results in 15 minutes
Designed to use in point of care settings for both symptomatic and asymptomatic people, Roche’s SARS-CoV-2 rapid antigen test delivers results in 15 minutes.
According to the company, the test showed a sensitivity of 96.52% and a specificity of 99.68% in 426 samples from two independent study centres.
The launch of the rapid antigen test is a result of a partnership with SD Biosensor, which has a global distribution agreement with Roche. SD Biosensor already launched a rapid antibody test in July, as part of the deal.
Roche currently offers molecular, serology, and digital solutions to diagnose and regulate Covid-19 during the initial stages of infection and recovery phase, as well as following the resolution of infection.
Roche Diagnostics CEO Thomas Schinecker said: “As the Covid-19 pandemic persists, healthcare systems remain challenged. Testing continues to be an important focus for many countries.
“Especially in the upcoming flu season, it is important to know whether a person has SARS-CoV-2 or the flu to ensure the right course of treatment.”
In May this year, Roche secured EUA status from FDA for its new Elecsys Anti-SARS-CoV-2 antibody test.