Roche, Basel, Switzerland, has developed and will launch its Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to SARS-CoV-2.
Antibody testing is central to help identify people who have been infected by the virus, and especially those who may have been infected but did not display symptoms. The test can support priority screening of high-risk groups, such as healthcare workers and food supply workers, who might already have developed a certain level of immunity and can continue serving or return to work.
The Elecsys Anti-SARS-CoV-2 immunoassay is an in vitro test using human serum and plasma to detect antibodies and determine the body’s immune reaction to the virus that causes covid-19. The test may be used in epidemiological research to help better understand the spread of the disease, and it may also be used together with molecular tests to aid in the diagnosis of suspected covid-19 patients. Hospitals and reference laboratories can run the test on Roche’s Cobas e analyzers.
“Following the mid-March launch of our high-volume PCR test to detect active infection of the disease, we are now going to launch a new antibody test in early May,” says Severin Schwan, chief executive officer of 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 aims to have the antibody test available in countries accepting the CE mark by early May, and is actively working with FDA for an emergency use authorization. Roche is planning on an accelerated ramp-up of monthly production to high-double-digit millions of tests by June and will further scale-up production as quickly as possible.
“Roche is deeply committed to supporting the global response to the COVID-19 pandemic,” says Thomas Schinecker, chief executive officer of 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.”
For more information, visit Roche.