WHO/BS.2020.2403 Establishment of the WHO International Standard and Reference Panel for anti-SARS-CoV-2 antibody

Overview

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is a zoonotic disease that was first reported in Wuhan, China in December 2019. The virus has spread worldwide and was reported a Public Health Emergency of International Concern by the WHO on January 30th, 2020. Vaccines and treatments are rapidly being developed and reliable assays are needed for their evaluation. The availability of an International Standard (IS) for antibodies would facilitate the standardisation of SARS-CoV-2 serological methods and allow for comparison and harmonisation of datasets across laboratories. This will help determine the antibody levels that are needed for efficacious vaccines and therapeutics, and improve our understanding of virus epidemiology. In this collaborative study, a pool of plasma from 11 SARS-CoV-2 convalescent patients, was evaluated for its suitability as an IS for anti-SARS-CoV-2 antibody by 51 laboratories across 125 methods including ELISAs, neutralisation assays, flow cytometry-based assays, lateral flow immunoassays, inhibitory assays and one Double Antigen Binding Assay.