Roche announces high-throughput antigen lab test, completing its set of COVID-19 diagnostics

Roche announced plans to provide an automated antigen test for COVID-19 designed to screen large volumes of people for active infections.

The Elecsys antigen test, running on the company’s cobas e immunochemistry analyzers, appears to complete the set of Roche’s different types of coronavirus tests and their respective settings: The Big Pharma will now offer PCR, antibody and antigen tests for use in both the laboratory and at the point of care.  

The latest addresses the throughput limitations of the rapid, point-of-care antigen diagnostic—designed to give coronavirus results in 15 minutes, on a per-patient basis—that it announced in early September.

And as with the previous portable test, Roche plans to first launch the high-throughput version in Europe and countries accepting the CE mark, with its rollout slated for the end of this year. The company said it will also submit the test to the FDA for a future emergency authorization in the U.S.

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The Elecsys lab test uses nasopharyngeal or oropharyngeal swab samples from symptomatic patients, gathered by healthcare professionals. It can process up to 300 per hour on a single machine—while individual results are available in less than 20 minutes—and can be used either as a complement or an alternative to PCR-based molecular testing.

“We are aware that governments and healthcare systems are under intense pressure to increase SARS-CoV-2 testing capacity to effectively manage the spread of the virus,” Roche Diagnostics CEO Thomas Schinecker said in a statement.

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“A high-volume antigen test is a valuable addition to the testing portfolio for helping diagnose SARS-CoV-2 infection,” Schinecker added. “Being able to quickly and correctly identify if someone has a SARS-CoV-2 infection is critical to informing patient management decisions and containing the spread of COVID-19.”

Antigen tests in general are not as sensitive as PCR tests. According to Roche, while a positive result with its Elecsys test most likely indicates an active infection, a negative result may need to be repeated or confirmed with a different test after one or two days.