Basel, Switzerland-based Roche said in a news release that the antigen test is designed as an aid in the diagnosis of SARS-CoV-2, the virus causing COVID-19, in markets accepting the CE Mark. Roche has also filed for FDA emergency use authorization (EUA) for the test, called the Elecsys.
Elecsys, a laboratory immunoassay for the in vitro qualitative detection of the nucleocapsid antigen of SARS-CoV-2, is touted as “highly accurate” by Roche.
In clinical studies, Elecsys showed a 94.5% sensitivity across 200 PCR confirmed symptomatic individuals and a 99.9% specificity across 2747 PCR negative symptomatic and screening individuals.
Roche intends to ramp up production to produce double-digit millions of tests per month by early 2021, depending on the demand of healthcare systems around the world. Healthcare professionals administer the test with nasopharyngeal or oropharyngeal swab samples.
“Healthcare systems remain under significant pressure to deliver robust testing options, with a sufficient number of tests available”, Roche Diagnostics CEO Thomas Schinecker said in the news release. “The launch of our high-throughput antigen test will provide additional testing capacity to reliably support healthcare systems in diagnosing SARS-CoV-2 infection, as a supplement to PCR testing.”