Roche to launch SARS-CoV-2 rapid antigen test

Roche is gearing up to launch an antigen test able to “reliably and quickly” triage people suspected of SARS-CoV-2, with results available in just 15 minutes.

The Swiss drug giant said it would launch the SARS-CoV-2 Rapid Antigen Test later this month in partnership with SD Biosensor in all countries accepting the CE mark, which includes the UK.

The SARS-CoV-2 Rapid Antigen Test is designed for use in point of care settings for both symptomatic and asymptomatic people, helping healthcare professionals to quickly identify infection with the virus.

It also serves as an initial screening test for individuals who have been exposed to SARS-CoV-2 infected patients or a high risk environment, the firm noted.

The test has a sensitivity of 96.52% and a specificity of 99.68%, based on 426 samples from two independent study centres.

At launch, there will be 40 million SARS-CoV-2 Rapid Tests available per month, but this capacity will increase more than two-fold at the end of this year.

“As the COVID-19 pandemic persists, healthcare systems remain challenged. Testing continues to be an important focus for many countries,” said Thomas Schinecker, chief executive of Roche Diagnostics.

“Especially in the upcoming flu season, it is important to know whether a person has SARS-CoV-2 or the flu to ensure the right course of treatment. COVID-19 testing solutions that provide healthcare professionals and patients with a quick answer regarding their infection status are critical to contain the community-spread of the COVID-19 virus.”