December 11, 2020 – Roche has launched a high-throughput SARS-CoV-2 antigen test as an aid in the diagnosis of SARS-CoV-2 infections, in markets accepting the CE Mark. Roche has also filed for Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (EUA).
The Elecsys SARS-CoV-2 Antigen test is a highly accurate laboratory immunoassay for the in vitro qualitative detection of the nucleocapsid antigen of SARS‑CoV‑2. In clinical studies, the Elecsys SARS-CoV-2 Antigen test showed a 94.5% sensitivity across 200 PCR confirmed symptomatic individuals and a 99.9% specificity across 2747 PCR negative symptomatic and screening individuals.
The company plans to ramp up production to have a double-digit million number of tests per month, in early 2021, depending on the demand of healthcare systems, globally. The test is performed by healthcare professionals and uses nasopharyngeal or oropharyngeal swab samples from patients with symptoms suggestive of COVID-19, or people with either known or suspected exposure to SARS-CoV-2. A widely available, laboratory-based automated antigen assay allows for cost and error reduction due to removal of manual handling as well as fast turn-around times and high test throughput.