Roche Launches Laboratory SARS-CoV-2 Antigen Test for High-Volume Testing of Suspected COVID-19 Patients

Roche (Basel, Switzerland) 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 US FDA.

Roche’s Elecsys SARS-CoV-2 Antigen test is an immunoassay intended for the qualitative detection of SARS-CoV-2 present in the respiratory tract including nasopharynx and oropharynx. 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. It could be used as an alternative or in conjunction with PCR testing. In symptomatic individuals, a positive result with the Elecsys SARS-CoV-2 Antigen test indicates an active SARS-CoV-2 infection with a likelihood of 94.5%. A negative result may require to be confirmed with a PCR test or repeated (antigen test) after one to two days, if other clinical indications point to a SARS-CoV-2 infection.

The Elecsys SARS-CoV-2 Antigen immunoassay runs on all cobas e immunochemistry analyzers which allow for these test to be run alongside other COVID-19 infectious diseases diagnostic markers available from Roche, which run on the cobas e systems. 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. Roche 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. 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.

“Healthcare systems remain under significant pressure to deliver robust testing options, with a sufficient number of tests available”, said Thomas Schinecker, CEO Roche Diagnostics. “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.”