The test uses nasopharyngeal or oropharyngeal swab samples taken from people with Covid-19 symptoms. Credit: Thiago Lazarino / Pixabay.

Roche is set to launch the Elecsys SARS-CoV-2 Antigen Test to offer support to high-volume testing of suspected Covid-19 patients.

The test will be launched for markets accepting the CE Mark by the end of this year.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

It is a highly precise laboratory immunoassay for the in vitro qualitative detection of the nucleocapsid antigen of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Roche said.

The company plans to submit an application for emergency use authorisation (EUA) for the antigen test to the Food and Drug Administration (FDA).

Conducted by healthcare specialists, the test uses nasopharyngeal or oropharyngeal swab samples taken from people with symptoms related to Covid-19 or those who were exposed to SARS-CoV-2.

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.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

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.

Furthermore, it will serve as a new addition to the comprehensive Roche diagnostic portfolio of solutions that can aid healthcare systems to fight Covid-19 through testing in the laboratory and at the point of care.

These solutions include both tests for the detection of acute SARS-CoV-2 infection and tests that measure the body’s immune response upon infection or vaccination.

Roche Diagnostics CEO Thomas said: “A high-volume antigen test is a valuable addition to the testing portfolio for helping diagnose SARS-CoV-2 infection.

“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.”

Medical Device Network Excellence Awards - Nominations Closed

Nominations are now closed for the Medical Device Network Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact

Excellence in Action
SC MEDICA’s minimally invasive, radiation free spinal facet fixation system, FFX® is transforming spinal pain management and improving outcomes for surgeons and patients alike. Learn how SC MEDICA’s award-winning technology is redefining standards in facet joint pain treatment.

Discover the Impact