Roche Announces High Throughput Antigen Lab Test, Completing COVID-19 Diagnostic Package

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Roche has 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, run on the company’s cobas e immunochemistry analyzers, appears to complement Roche’s set of different types of coronavirus tests and their respective parameters: The Big Pharma will now offer PCR, antibody and antigens for both laboratory and point-of-care use.

The latest deals with the flow limitations of rapid point-of-care antigen diagnostics – designed to give coronavirus results in 15 minutes, per patient – which it announced in early September.

And as with the previous portable test, Roche plans to launch the high-speed version first in Europe and countries accepting the CE mark, which is slated for deployment later this year. The company said it would also submit the test to the FDA for future emergency clearance in the United States.

RELATED: Roche to Launch 40 Million Rapid Coronavirus Antigen Tests Per Month, From Europe

The Elecsys laboratory test uses nasopharyngeal or oropharyngeal swabs from symptomatic patients, collected 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 as a supplement or as an alternative to PCR-based molecular testing.

“We recognize that governments and health systems are under intense pressure to increase the testing capacity for SARS-CoV-2 in order to effectively manage the spread of the virus,” said Thomas Schinecker, CEO of Roche Diagnostics, in a press release.

RELATED: FDA Authorizes New Roche Test to Identify High-Risk COVID-19 Patients

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

Antigenic 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.


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