Switzerland-based multinational healthcare company, Roche offers its expertise in diagnostics and pharmaceuticals. Recently Roche got approval for laboratory based Elecsys SARS-COV-2 Antigen Test to facilitate high volume testing in India. This lab-based Elecsys SARS-COV-2 Antigen Test which had earlier received CE mark, has lately got the import licence from CDSCO.
This antigen test is performed by healthcare professionals, can be used as either an alternative or in conjunction with PCR testing. It is an immunoassay for the qualitative detection of SARS-CoV-2 present in the respiratory tract including nasopharynx and oropharynx for diagnosing symptomatic patients and exposed asymptomatic individuals.
To manage covid-19 effectively and contain community spread, robust diagnostic testing capacity is of utmost importance. Roche has more than 2000 instrument installations across India and with the high accuracy, high-throughput lab antigen test, it will boost up the testing capabilities of the Indian healthcare system. Roche ECLIA antigen assay is a next generation test which will be beneficial in reducing the burden on PCR testing, overcoming major limitations of rapid antigen tests by providing faster reporting, longer sample stability, full automation, no subjectivity and better sensitivity. These positives make this assay a top choice for Covid-19 testing. Clinical studies have shown that Elecsys SARS-CoV-2 Antigen test showed 94.5% sensitivity across 390 PCR confirmed symptomatic individuals and 99.9% specificity across 2747 PCR negative symptomatic, exposed and screening individuals.