- The serology test has a specificity greater than 99.8% and sensitivity of 100% (14 Days post-PCR confirmation) The high specificity of the test is crucial to determine reliably if a person has been exposed to the virus and if the patient has developed antibodies
- Roche will provide high double-digit millions of tests already in May for countries accepting the CE mark and in the U.S. under Emergency Use Authorization, further ramping up capacities thereafter
- The test is available on Roche’s cobas e analyzers which are widely available around the world
Basel, 3 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA)2 for its new Elecsys® Anti-SARS-CoV-2 antibody test. The test is designed to help determine if a patient has been exposed to the SARS-CoV-2 virus and if the patient has developed antibodies against SARS-CoV-2. Roche has already started shipping the new antibody test to leading laboratories globally and will ramp up production capacity to high double-digit millions per month to serve healthcare systems in countries accepting the CE mark1 as well as the U.S.