Roche announced that it has launched a high-throughput SARS-CoV-2 antigen test as an aid in the diagnosis of SARS-CoV-2 infections in markets accepting the CE Mark. Roche has also filed for emergency use authorization (EUA) from the U.S. Food and Drug Administration, according to a press release.
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 percent sensitivity across 200 PCR confirmed symptomatic individuals and a 99.9 percent specificity across 2747 PCR negative symptomatic and screening individuals.
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. 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 percent. 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 analyzers, allowing it 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 analyzer, depending on the analyzer.
