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.
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.”