WHO issues its first emergency use listing for a SARS-CoV-2 self-test

news 18 July 2022

Today, WHO listed the first quality-assured SARS-CoV-2 self-test for emergency use. The OnSite COVID-19 Ag Self-Test is a rapid test, which uses nasal swabs to detect SARS-CoV-2, designed for the general public, including adults and children aged 12 and above with adult supervision.

This listing is a key step in ensuring enhanced access to decentralized, fast and reliable diagnostics and an effective COVID-19 response strategy across Member States.

WHO recommends that COVID-19 self-testing, using SARS-CoV-2 antigen-detection rapid test (Ag-RDTs), should be offered in addition to professionally administered testing services.

Access to affordable and quality-assured SARS-CoV-2 Ag-RDTs, including tests for self-testing, should particularly be prioritized for settings where there is limited access to more complex and expensive technologies such as PCR tests. COVID-19 self-testing complements, rather than replaces, professional testing services using Ag-RDTs.

The EUL for SARS-CoV-2 self-tests was opened for submission when WHO issued a recommendation on self-testing in March 2022, with the first dossier received in April 2022.

How emergency use listing works

The WHO Emergency Use Listing (EUL) procedure assesses the suitability of health products during public health emergencies. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy/performance and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.

To expedite the availability of In Vitro Diagnostics (IVDs), the WHO Emergency Use Listing (EUL) procedure aims to assist procurement agencies and Member States with their decisions regarding the suitability for use of a specific IVD, based on a minimum set of available quality, safety, and performance data. The list of SARS‐CoV‐2 IVDs that have received WHO EUL is available on the WHO website.