October 13, 2020 – Roche (Basel, Switzerland) intends to launch a high-volume SARS-CoV-2 Antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.
The test is planned to be made available at the end of 2020 for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).
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, Roche says. The test is performed by healthcare professionals and uses nasopharyngeal or oropharyngeal swab samples from patients with signs and symptoms suggestive of COVID-19, or people with either known or suspected exposure to SARS-CoV-2.
The Elecsys SARS-CoV-2 Antigen immunoassay runs on all cobas e immunochemistry analyzers which are widely available around the world. These fully automated systems can provide test results in 18 minutes for a single test (excluding time for sample collection, transport, and preparation), with a throughput of up to 300 tests per hour from a single analyzer, depending on the analyzer.
A 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.