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Disease/health condition -
Neglected tropical diseases, Dengue, Arboviral diseases
IgM antibodies to dengue virus
Assay format
Lateral flow RDT
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 dengue virus NS1 antigen), and for population surveys.
Specimen types
Serum, Plasma
WHO prequalified or recommended products
N/A
GMDN
48925
Dengue virus immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of immunoglobulin M (IgM) antibodies to Dengue virus in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method* . This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
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* lateral flow test
EMDN
W0105099007
DENGUE - RT & POC
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/emdnWHO 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
The SAGE IVD recommended inclusion on the EDL of the EIA or RDT for DENV IgM only if used in combination with the EIA or RDT for DENV NS1 antigen in a specified algorithm.
The Group noted that the tests for DENV IgM cross-react with other flaviviruses, and seroconversion cannot be measured owing to the high rate of attrition in the countries in which dengue is endemic. They noted that guidelines for DENV testing would become available shortly. The Group 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 the world. Antibody and antigen tests are essential for detection, case management, surveillance and confirmation of outbreaks. Detection of antigens can be used to diagnose an early infection, while viraemia present during the acute phase requires use of DENV-1-4 real-time RT-PCR plus IgM ELISA or NS1 antigen ELISA.
Several studies of use of IgM ELISA and RDTs have been conducted, but no systematic review has been done to determine any risk of bias or the applicability of the findings. The studies show that the sensitivity and specificity of these tests is variable and low, and they are not accurate enough to be used on their own. 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.
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