Roche has launched a CE-marked high-throughput SARS-CoV-2 antigen test as an aid in the diagnosis of SARS-CoV-2 infections. Roche has also filed for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration.

The Elecsys® SARS-CoV-2 Antigen test is a highly accurate laboratory immunoassay for the in vitro qualitative detection of the nucleocapsid antigen of SARS‑CoV‑2.

In clinical studies, the Elecsys SARS-CoV-2 Antigen test showed a 94.5% sensitivity across 200 PCR confirmed symptomatic individuals (performance evaluation was performed in symptomatic individuals with a cobas® SARS-CoV-2 RT-PCR Target 2 Ct value <30) and a 99.9% specificity across 2747 PCR negative symptomatic and screening individuals.

It is planned to ramp up production to have a double-digit million number of tests per month, in early 2021, depending on the demand of healthcare systems, globally.

The test is performed by healthcare professionals and uses nasopharyngeal or oropharyngeal swab samples from patients with symptoms suggestive of COVID-19, or people with either known or suspected exposure to SARS-CoV-2.

A widely available, laboratory-based automated antigen assay allows for cost and error reduction due to removal of manual handling as well as fast turn-around times and high test throughput. 

Elecsys SARS-CoV-2 Antigen test
Roche’s Elecsys SARS-CoV-2 Antigen test is an immunoassay intended for the qualitative detection of SARS-CoV-2 present in the respiratory tract, including nasopharynx and oropharynx.

The Elecsys SARS-CoV-2 Antigen test is performed by healthcare professionals and could be used as an alternative or in conjunction with PCR testing. This is highly beneficial where reliable laboratory PCR testing is limited or not available.

In symptomatic individuals, a positive result with the Elecsys SARS-CoV-2 Antigen test indicates an active SARS-CoV-2 infection with a likelihood of 94.5%. A negative result may require to be confirmed with a PCR test or repeated (antigen test) after one to two days if other clinical indications point to a SARS-CoV-2 infection.

The Elecsys SARS-CoV-2 Antigen immunoassay runs on all cobas e immunochemistry analysers which are widely available around the world and allow for these test to be run alongside other COVID-19 infectious diseases diagnostic markers available from Roche, which run on the cobas e systems.

These fully automated systems can provide test results in 18 minutes for a single test (excluding time for sample collection, transport, and preparation), with a throughput of up to 300 tests per hour from a single analyser, depending on the analyser.