Roche has launched a high-throughput SARS-CoV-2 antigen test in markets, accepting the CE Mark to help in detecting Covid-19 infections.
The company has also sought emergency use authorisation (EUA) from the US Food and Drug Administration for the Elecsys SARS-CoV-2 Antigen test.
The highly accurate laboratory immunoassay is used for in vitro qualitative detection of the nucleocapsid antigen of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2).
Data from clinical studies showed that the test had a 94.5% sensitivity across 200 PCR confirmed symptomatic persons and a 99.9% specificity across 2,747 PCR negative symptomatic and screening individuals.
The SARS-CoV-2 antigen test can be used as an alternative or along with PCR testing.
Roche Diagnostics CEO Thomas Schinecker said: “Healthcare systems remain under significant pressure to deliver robust testing options, with a sufficient number of tests available.
“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.”
Performed by healthcare specialists, the test uses nasopharyngeal or oropharyngeal swab samples from patients with symptoms or those exposed to SARS-CoV-2.
The widely available assay could aid in cost and error reduction as it alleviates the need for manual handling and provides fast turn-around times and a high-test throughput.
The Elecsys SARS-CoV-2 Antigen immunoassay works on all Roche cobas e immunochemistry analysers available globally. It can deliver results in 18 minutes for a single test.
It has a throughput of up to 300 tests per hour from a single analyser. A positive result with the antigen test shows an active SARS-CoV-2 infection.
Roche intends to increase production plans to have a double-digit million number of tests per month by early next year across the world.