Download
Disease/health condition -
Neglected tropical diseases, Dengue, Arboviral diseases
Qualitative dengue virus nucleic acid amplification test
Assay format
NAAT
Information History
First added in 2019
Changed in 2024
Purpose type
Surveillance, Diagnosis
Purpose
For surveillance (serotype differentiation) and confirmation of outbreaks. For confirmation of infection during the acute stage (within 5 days of symptom onset).
Specimen types
Serum
WHO prequalified or recommended products
N/A
GMDN
48921
Dengue virus serotyping (types 1-4) IVD, kit, nucleic acid technique (NAT)
A collection of reagents and other associated materials intended to be used for the serotype determination of Dengue virus infection caused by serotypes 1-4 in a clinical specimen, using a nucleic acid technique (NAT).
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 2005-2024EMDN
W0105040511
DENGUE VIRUS - NA REAGENTS
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
Related Medical Devices in MeDevIS
The SAGE IVD recommended conditional inclusion on the EDL of tests for DENV nucleic acid, pending submission of better-designed studies with commercial tests and evaluation in clinical settings. The Group noted that it should be used in conjunction with EIA or RDT for DENV IgM and NS1 antigen in a specified algorithm.
The Group noted that the test should be used only for confirmation; a standardized assay would be required for its application in diagnosis. The test is suitable only for use in reference laboratories, where it would also be useful for tracking changes in the virus serotype. Recommended test purpose: for surveillance (serotype differentiation) and for confirmation of outbreaks. Recommended algorithms for laboratory diagnosis of dengue (2023) are available at https://iris.paho.org/handle/10665.2/57555
Dengue fever is the most rapidly spreading mosquito-borne viral disease in the world. There are many NAATs for DENV, which can be used with whole blood, sera or tissue specimens taken from patients during the acute phase of DENV infection.
Data were available from only two primary studies on banked sets of DENV- positive sera from the Caribbean and from Thailand for analysis in six tests of 279 positive samples and 78 negative samples. The results showed good sensitivity and specificity in four of the six tests. Their performance appears promising, but the small number of participants (particularly DENV-negative) and the availability of only two studies provide only weak evidence. WHO has published new recommendations in 2023 and are available at https://iris.paho.org/handle/10665.2/57555
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