Swiss healthcare company Roche has expanded its Covid-19 test portfolio with the introduction of Elecsys SARS-CoV-2 antigen test in the CE mark accepting markets.
The company is also seeking emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for the SARS-CoV-2 antigen test.
The Elecsys SARS-CoV-2 antigen test is said to be a precise 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, the Elecsys test facilitates the detection of SARS-CoV-2 present in the respiratory tract including nasopharynx and oropharynx.
According to the company, the Elecsys SARS-CoV-2 antigen test demonstrated 94.5% sensitivity across 200 PCR confirmed symptomatic individuals and 99.9% specificity across 2747 PCR negative symptomatic and screening individuals in clinical studies.
The test is performed using nasopharyngeal or oropharyngeal swab samples from patients with symptoms suggestive of Covid-19, as well as with people with either known or suspected exposure to SARS-CoV-2.
The Elecsys SARS-CoV-2 antigen immunoassay is suitable to run on all cobas e immunochemistry analysers.
With a throughput of up to 300 tests per hour from a single analyser, the fully automated systems hold the potential to deliver test results in 18 minutes for a single test.
Roche Diagnostics CEO Thomas Schinecker said: “Healthcare systems remain under significant pressure to deliver robust testing options, with a sufficient number of tests available.
“The launch of our high-throughput antigen test will provide additional testing capacity to reliably support healthcare systems in diagnosing SARS-CoV-2 infection, as a supplement to PCR testing.”
In September this year, Roche introduced its Elecsys Anti-SARS-CoV-2 S antibody test in the CE mark accepting markets.
Roche’s other Covid-19 portfolio consists of high-volume molecular test, the SARS-CoV-2 laboratory-based antibody test, an IL-6 test, v-TAC test and two SARS-CoV-2 rapid antibody tests.
