In vitro diagnostics detecting antibodies to SARS-CoV2 virus

Overview

This document has been prepared to assist manufacturers in correctly compiling the documentary evidence for the purposes of WHO EUL review of IVDs to detect SARS-CoV-2 specific antibodies (IgM, IgG) and describes the required information to support submissions to WHO. This document should be used together with WHO document “Emergency Use Listing (EUL) Procedure” 1 for candidate IVDs for use in the context of a public health emergency of international concern and the document “Invitation to manufacturers of in vitro diagnostics for SARS-CoV-2 to submit an application for EUL by WHO”. 2 Manufacturers3 who wish to submit the documentary evidence for an IVD should read these documents carefully and fully adopt the guidance therein to compile a successful submission.