Invitation to manufacturers of in vitro diagnostics for SARS-CoV-2 to submit an application for emergency use listing by WHO

Overview

The global spread of COVID-19 has dramatically increased the number of suspected cases and the geographic area where COVID-19 testing is needed to identify infected individuals. In order to do this, in vitro diagnostics (IVDs) of assured quality, safety and performance are required.

On 30 January 2020, the Director-General declared that the outbreak of COVID-19 caused by SARS-CoV2 constitutes a Public Health Emergency of International Concern (PHEIC). IVDs of assured quality, safety and performance are needed for e.g., screening suspect cases, diagnosis, case cluster finding or serosurveillance. Because this is a new strain of coronavirus that has not been previously identified in humans, there are several assays to detect SARS-CoV-2 now under development.