Antigen-detection in the diagnosis of SARS-CoV-2 infection

Overview

Direct detection of SARS-CoV-2 viral proteins (antigens) in nasal swabs and other respiratory secretions using lateral flow immunoassays (also known as rapid diagnostic tests, RDTs) offers a faster and less expensive method to test for SARS-CoV-2 than the reference method, nucleic acid amplification tests (NAATs). This interim guidance offers recommendations on the priority uses of antigen-detecting rapid diagnostic tests (Ag-RDTs) in specific populations and settings, including (i) for primary case detection in symptomatic individuals suspected to be infected and asymptomatic individuals at high risk of COVID-19, (ii) for contact tracing, (iii) during outbreak investigations and (iv) to monitor trends of disease incidence in communities. Ag-RDTs meeting minimum performance requirements can be used outside of clinical and laboratory settings, including in communities, by trained operators in accordance with instructions. The guidance additionally provides recommendations on implementation, product selection and storage.

CORRIGENDUM

Infographics

Use of antigen detection rapid diagnostic testing

Diagnostic testing for SARS-CoV-2 infection

Why testing is important?

This document updates the first interim guidance on the potential role of Ag-RDTs in the diagnosis of COVID-19 (Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays) released on 11 September 2020.  It incorporates new findings concerning test performance across Ag-RDT brands and sample types. The current version of all WHO information products and publications is authoritative.