Product News: Roche launches laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients

Roche has announced it has launched a high-throughput SARS-CoV-2 antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections, in markets accepting the CE Mark. Roche has also filed for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration.

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. It is planned 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.

“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.”

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 Elecsys^® SARS-CoV-2 Antigen test is performed by healthcare professionals and could be used as an alternative or in conjunction with PCR testing. This is highly beneficial where reliable laboratory PCR testing is limited or not available. A positive result with the Elecsys^® SARS-CoV-2 Antigen test, in symptomatic individuals, 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 analysers which are widely available around the world and allow for these tests 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 analyser, depending on the analyser.

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