Technical specifications for selection of essential in vitro diagnostics for SARS-CoV-2

Overview

NOTE: This publication is under review and a new version will be published during the third quarter of 2022.

Technical specifications for in vitro diagnostics (IVDs) constitute a set of predefined criteria and baseline requirements to ensure good quality, safety, performance and efficacy. The specifications are companions to the WHO Model List of Essential In Vitro Diagnostics (EDL) and are provided to help Member States, donor agencies and nongovernmental organizations (NGOs) select specific products within each test category of the EDL and guide procurement decisions. The present publication defines the basic generic technical characteristics of IVDs for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) listed in WHO EDL 3. WHO will review and update this document periodically.