Roche to launched COVID-19 antibody test in early May

Roche will develop its Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to SARS-CoV-2 and launch it in early May in countries accepting the CE mark. The company says it is actively working with the FDA for an Emergency Use Authorisation.

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 may be used in epidemiological research to help better understand the spread of the disease and 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 analysers, which are widely available in laboratories around the world.

Roche notes that antibody testing is central to help identify people who have been infected by the virus, especially those who may have been infected but did not display symptoms. Additionally, the test can support priority screening of high risk groups, such as healthcare workers, food supply workers who might already have developed a certain level of immunity and can continue serving and/or return to work.

Severin Schwan, CEO Roche Group, said: “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. 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.”

Thomas Schinecker, CEO Roche Diagnostics, commented: “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.”