Roche has launched a SARS-CoV-2 antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections.

The laboratory-based Elecsys SARS-CoV-2 Antigen test had earlier received CE mark has recently obtained the import license from CDSCO. The automated lab-based antigen test could be useful in diagnosing symptomatic patients and exposed asymptomatic individuals. In addition, it will facilitate frequent screening of individuals in high-risk settings.

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 test can help provide faster reporting and could also be used in setups wherein the PCR testing is either limited or not available, thus reducing turnaround time for samples.

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 per cent. 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 in India and allow for these test to be run alongside other COVID-19 and other infectious diseases markers available from Roche, which run on the cobas e systems. This test, running on the electrochemiluminescence technology, ensures high accuracy and precision in testing. 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.