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Disease/health condition - Neglected tropical diseases, Dengue, Arboviral diseases
Dengue virus nonstructural protein 1 (NS1) antigen
Setting:
2. Laboratory
Tiered Testing Service:
District hospital with laboratory Regional or provincial hospital with laboratory
Assay format
Immunoassay
Information History
First added in 2019
Changed in 2024
Purpose type
Aid to diagnosis, Surveillance
Purpose
To aid in the diagnosis of acute dengue infection (always in combination with IgM antibodies to dengue virus), and for population surveys.
Specimen types
Serum
WHO prequalified or recommended products
N/A
GMDN

48907

Dengue virus antigen IVD, kit, enzyme immunoassay (EIA)

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Dengue virus in a clinical specimen, using an enzyme immunoassay (EIA) method.

The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024
EMDN

W0105040611

DENGUE VIRUS

The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdn
WHO supporting publications
Pan American Health Organization. Recommendations for Laboratory Detection and Diagnosis of Arbovirus Infections in the Region of the Americas. Washington, D.C.: PAHO; 2023. https://iris.paho.org/handle/10665.2/57555 ; Organización Panamericana de la Salud. Recomendaciones para la detección y el diagnóstico por laboratorio de infecciones por arbovirus en la Región de las Américas. Washington, D.C.; 2022. https://iris.paho.org/handle/10665.2/56321 ; World Health Organization. (‎2022)‎. Laboratory testing for Zika virus and dengue virus infections: interim guidance, 14 July 2022. World Health Organization. https://iris.who.int/handle/10665/359857 ; World Health Organization. (‎2009)‎. Dengue guidelines for diagnosis, treatment, prevention and control : new edition. World Health Organization. https://iris.who.int/handle/10665/44188 ; World Health Organization. (‎2025)‎. WHO guidelines for clinical management of arboviral diseases: dengue, chikungunya, Zika and yellow fever. World Health Organization. https://iris.who.int/handle/10665/381804
Technical specifications
N/A
Related Medical Devices in MeDevIS
The SAGE IVD recommended inclusion on the EDL of the EIA or RDT for dengue NS1 antigen only if used in combination with the EIA or RDT for DENV IgM in a specified algorithm. The Group noted that guidelines for DENV testing would become available shortly and recommended that the test be prequalified to ensure that the most appropriate tests are available. Recommended test purpose: as an aid in the diagnosis of dengue fever (always in combination with NS1) and for population surveys.
Dengue fever is the most rapidly spreading mosquito-borne viral disease in theworld. Antibody and antigen tests are essential for case management, surveillance and confirmation of outbreaks. There is substantial evidence that NS1 ELISA and RDT tests have poor sensitivity when used alone, although their specificity is consistently high. Several studies have evaluated the combination of NS1 and IgM, as separate tests or in a purpose-made dual RDT, which appears to increase sensitivity without compromising specificity, but no systematic review of studies of this test combination has been reported.
A systematic review and meta-analysis of 30 studies showed low sensitivity and high specificity for two different assays: sensitivity 66% (95% CI 61 ; 71) and 74% (95% CI 63 ; 82); specificity 99% (95% CI 96 ; 100) and 99% (95% CI 97 ; 100).
World Health Organization. (‎2019)‎. The selection and use of essential in vitro diagnostics: report of the second meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (‎including the second WHO model list of essential in vitro diagnostics)‎. World Health Organization. https://iris.who.int/handle/10665/329527