Elecsys SARS-CoV-2 Antigen test will facilitate in vitro qualitative detection of the nucleocapsid antigen of SARS-CoV-2
Roche has unveiled plans to introduce a high-volume SARS-CoV-2 antigen test to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
The company plans to launch Elecsys SARS-CoV-2 antigen test by the end of this year in markets accepting the CE mark.
It is also planning to submit an application to secure emergency use authorisation (EUA) status from the US Food and Drug Administration (FDA).
The Elecsys SARS-CoV-2 antigen test is a laboratory immunoassay for the in vitro qualitative detection of the nucleocapsid antigen of SARS-CoV-2.
Designed to be used as an alternative or in conjunction with PCR testing, Elecsys SARS-CoV-2 Antigen test enables the detection of a specific antigen of SARS-CoV-2 present in the respiratory tract, including nasopharynx and oropharynx.
The antigen test is performed by using nasopharyngeal or oropharyngeal swab samples from patients with signs and symptoms suggestive of Covid-19, as well as people with either known or suspected exposure to SARS-CoV-2.
Elecsys SARS-CoV-2 antigen immunoassay runs on all cobas e immunochemistry analysers
All cobas e immunochemistry analysers, which can deliver test results in 18 minutes for a single test, can be used to run the Elecsys SARS-CoV-2 antigen immunoassay.
Roche Diagnostics CEO Thomas Schinecker said: “We are aware that governments and healthcare systems are under intense pressure to increase SARS-CoV-2 testing capacity to effectively manage the spread of the virus.
“A high-volume antigen test is a valuable addition to the testing portfolio for helping diagnose SARS-CoV-2 infection.”
The company is offering various diagnostic solutions for Covid-19 testing, including an IL-6 test to detect a severe inflammatory response in patients with confirmed Covid-19, a SARS-CoV-2 laboratory-based qualitative antibody test, a SARS-CoV-2 rapid antibody test and others.
In September, Roche introduced its Elecsys Anti-SARS-CoV-2 S antibody test in the CE mark accepting markets.