Receive our newsletter – data, insights and analysis delivered to you
  1. News
October 14, 2020

Roche to launch antigen test for Covid-19 patients

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

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.

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.

Content from our partners
Precision wire: The future of bespoke medical treatment
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
“This technique means everything to us”: How CGM devices empower users 

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.”

Related Companies

Topics in this article:
NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU