The SARS-CoV-2 antigen test can be used as an alternative or along with PCR testing. Credit: F. Hoffmann-La Roche Ltd.

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.

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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.

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“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.