Roche Launches New COVID-19 Antibody Test System

Roche (Basel, Switzerland) will soon launch its Elecsys® Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to SARS-CoV-2 that causes the COVID-19 disease. The Elecsys Anti-SARS-CoV-2 immunoassay is an in vitro test, using human serum and plasma drawn from a blood sample, to detect antibodies and determine the body’s immune reaction to SARS-CoV-2. The test can be used in epidemiological research to help better understand the spread of the disease and can also be used together with molecular tests to aid in the diagnosis of suspected COVID-19 patients. The test can be run on Roche’s fully-automated cobas e analyzers which can provide SARS-CoV-2 test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending upon the analyzer.

Roche aims to have the antibody test available by early May in countries accepting the CE mark and is actively working with the FDA for an Emergency Use Authorization. The company is planning on an accelerated ramp up of monthly production to high double-digit million tests by June and will further scale up production as fast as possible.

“Following the launch of our high-volume PCR test in mid-March to detect active infection of the disease, we are now going to launch a new antibody test in early May,” said Severin Schwan, CEO Roche Group. “Every reliable test on the market serves its purpose for healthcare systems to help us overcome this pandemic. Roche is collaborating closely with health authorities and ramping up production to ensure fast availability of the test globally.”

“Roche is deeply committed to supporting the global response to the COVID-19 pandemic,” said Thomas Schinecker, CEO Roche Diagnostics. “Timely availability and fast access to reliable, high quality tests are essential for healthcare systems. The antibody test is an important next step in the fight against COVID-19. Roche’s antibody test can be quickly scaled and made broadly available around the world as our instrument infrastructure is already in place.”