Roche coronavirus antibody test receives FDA Emergency Use Authorization
Topics: ROCHE CORONAVIRUS
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 mark as well as the U.S.
Roche’s SARS-CoV2 antibody test, which has a specificity greater than 99.8% and 100% sensitivity3 (14 Days post-PCR confirmation), can help assess patients’ immune response to the virus.
As more is understood about immunity to SARS-CoV-2, the test may help to assess who has built up immunity to the virus. ■