WHO/BS/2022.2426 Rev: A Collaborative Study to Evaluate the Proposed 1st WHO International Standard for SARS-CoV-2 Antigen

Overview

This report describes the collaborative study evaluation of a candidate for the proposed 1st WHO International Standard for SARS-CoV-2 Antigen. The choice of source material and concentration for the candidate was guided by the results of a pilot study conducted in 2021. The candidate comprised a lyophilized preparation of formaldehyde-inactivated cell culture-grown SARS-CoV-2 Omicron variant (subvariant BA.1) formulated in Copan Universal Transport Medium (UTM-RT). The performance of the candidate was evaluated as part of a panel of nine samples using 18 different SARS-CoV-2 antigen detection tests comprising both rapid diagnostic tests (RDTs) and laboratory instrument-based immunoassays.