Roche to launch high-volume SARS-CoV-2 antigen test

By Rachel Arthur contact

- Last updated on GMT


Related tags: Roche, COVID-19

Roche plans to launch its high-volume Elecsys SARS-CoV-2 Antigen test at the end of 2020 in markets accepting the CE mark; while the company will file for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA).

The Elecsys 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 COVID-19 symptoms, or people with suspected exposure to SARS-CoV-2.

It can be used either as an alternative or in conjunction with PCR testing: an advantage where reliable laboratory PCR testing is not available or if there is not enough capacity.

Antigen tests detect specific proteins from a pathogen. If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a positive result. In general, antigen tests have a high specificity, though are not as sensitive as PCR tests, and so a negative result should be analysed with other factors such as clinical symptoms. Roche will outline performance evaluations around sensitivity and specificity of the Elecsys test at the time of launch.

The Elecsys SARS-CoV-2 Antigen immunoassay runs on any cobas e immunochemistry analyser. These fully automated systems can provide test results in 18 minutes for one test; and up to 300 tests per hour from a single analyser.

As these are widely available around the world, Roche says this will help increase testing capacity. A laboratory based automated antigen assay also allows for cost and error reduction due to removal of manual handling as well as fast turn-around times and high test throughput, says the company.

Thomas Schinecker, CEO Roche Diagnostics, stated, “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. 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.”

Roche’s portfolio of SARS-CoV-2 tests include the cobas SARS-CoV-2 & Influenza A/B Test; a test that can differentiate between flu and COVID-19​ which gained Emergency Use Authorization from the FDA earlier this year.

In March, Roche also received FDA EUA for a high-volume molecular test to detect SARS-CoV-2. In May, its COVID-19 antibody test received FDA EUA. In July it added a Rapid Antibody Test to its portfolio, with SD Biosensor as distribution partner, that allows the detection of antibodies against COVID-19 at the point of care.

Related topics: Bio Developments

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