SOUTH SAN FRANCISCO (dpa-AFX) - Swiss drug maker Roche Group (RHHBY) announced Tuesday that it plans to launch laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients.
The Elecsys SARS-CoV-2 Antigen test is an automated laboratory assay intended as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 or SARS-CoV-2 infection.
The company plans to make it available at the end of 2020 for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorisation from the U.S. Food and Drug Administration.
According to the company, its Elecsys antigen test is a highly accurate laboratory immunoassay for the in vitro qualitative detection of the nucleocapsid antigen of SARS-CoV-2.
The test is performed by healthcare professionals and uses nasopharyngeal or oropharyngeal swab samples from patients with signs and symptoms suggestive of COVID-19, or people with either known or suspected exposure to SARS-CoV-2.
It runs on all cobas e immunochemistry analysers which are widely available around the world. These fully automated systems provide test results in 18 minutes for a single test, with a throughput of up to 300 tests per hour from a single analyser, depending on the analyser.
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