In vitro diagnostics detecting SARS-CoV-2 nucleic acid and rapid diagnostics tests detecting SARS-CoV-2 antigen

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. The World Health Organization (WHO) revised the Emergency Use Listing (EUL) Procedure (previously referred to as the Emergency Use Assessment and Listing Procedure (EUAL)) on 8 January 2020, to be used primarily during a Public Health Emergency of International Concern (PHEIC). The EUL process is based on an essential set of available quality, safety and performance data. It isintended to expedite the availability of IVDs needed in PHEIC situations and, in that context, to assist interested UN procurement agencies and Member States in determining the acceptability of using specific products for time limited procurement.