Roche gets approval for lab-based Elecsys SARS-CoV-2 antigen test

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 a CE mark and 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.

A company statement informed, “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 will be highly beneficial in reducing the burden on PCR testing, it 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.”

Narendra Varde, Managing Director, Roche Diagnostics India and Neighboring Markets, “Robust diagnostic testing capacity is the bedrock to manage COVID-19 and contain community spread. With >2000 instrument installations across India, the high accuracy, high-throughput laboratory antigen test will give a vital boost to our testing capabilities supporting the Indian healthcare system in the diagnosis of SARS-CoV-2 infections.”

The statement updated, “The Elecsys SARS-CoV-2 Antigen test is a highly accurate test for patients with signs and symptoms suggestive of COVID-19, or people with either known or suspected exposure to SARS-CoV-2. In clinical studies, the Elecsys SARS-CoV-2 Antigen test showed a 94.5 per cent sensitivity across 390 PCR confirmed symptomatic individuals* and a 99.9 per cent specificity across 2747 PCR negative symptomatic, exposed and screening individuals.”

It added, “The Elecsys SARS-CoV-2 Antigen immunoassay runs on all cobas e immunochemistry analysers which are widely available in India and allow for these tests 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, 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.”