Roche antibody test approved in US

Country

Switzerland

A new serology test designed to detect protective antibodies in people who have been exposed to the SARS-CoV-2 virus has been given emergency use authorisation by the US Food and Drug Administration, the developer Roche announced on 3 May. The test has also received a CE mark and is eligible for use in Europe. Roche said the test has a specificity of greater than 99.8% and a 100% sensitivity. The sensitivity of a diagnostic test is the proportion of true positives that are correctly identified whereas the specificity is the proportion of true negatives.