Every year, dengue outbreaks cause substantial humanitarian and economic hardship worldwide. Simple and cost-effective serological rapid diagnostic tests (RDTs) are currently the preferred methods widely used in laboratories and clinics in dengue-endemic areas. While the sensitivity and specificity of most of the RDTs have been studied, their diagnostic performance can vary across different settings and populations, highlighting the need for ongoing evaluations. This study evaluated the performance of five commercially available dengue RDTs for the detection of infection using the non-structural (NS1) antigen and IgM/IgG antibodies. Well-characterized archived dengue positive and confirmed dengue negative serum samples from the Aga Khan University, Pakistan, were screened. RDTs (SD Bioline Dengue Duo, Artron Dengue virus IgG/IgM and Ag cassette, Standard Q Dengue Duo, Humasis Dengue combo kit, and ALL Test Dengue Combo Rapid Test) were evaluated separately and in combination for the determination of diagnostic parameters (positive for NS1 and IgM). The enzyme-linked immunosorbent assay (ELISA) was considered the reference assay. The sensitivity of the RDTs ranged from 65.1% to 94.1% when compared to NS1 ELISA samples [255 NS1 positive and 175 NS1 negative samples], with the dengue virus IgG/IgM antibody and NS1 antigen cassette demonstrating the highest overall sensitivity. All RDTs showed a specificity of >99%. The dengue virus IgG/IgM antibody and NS1 antigen cassette (Artron Laboratories Inc.) achieved the highest overall diagnostic accuracy (96.3%). The dengue virus IgG/IgM antibody and NS1 antigen cassette (Artron Laboratories Inc.) achieved the highest overall diagnostic accuracy (96.28%). Dengue virus IgG/IgM antibody and NS1 antigen cassette showed the highest sensitivity and diagnostic accuracy, while all RDTs showed similar specificity. These findings highlight the importance of selecting appropriate diagnostic tests based on sensitivity and specificity.
Cite this paper
Sapkota, J. , Hasan, R. , Azizullah, Z. , Shams, H. , Dittrich, S. and Tetteh, K. K. A. (2025). Comparative Performance Evaluation of Dengue Rapid Diagnostic Tests Detecting NS1 Antigen, IgM and IgG Antibodies for Diagnosis of Recent Dengue Infection. Open Access Library Journal, 12, e13924. doi: http://dx.doi.org/10.4236/oalib.1113924.
Ferreira-de-Lima, V.H. and Lima-Camara, T.N. (2018) Natural Vertical Transmission of Dengue Virus in Aedes Aegypti and Aedes Albopictus: A Systematic Review. Parasites & Vectors, 11, Article No. 77. https://doi.org/10.1186/s13071-018-2643-9
Paupy, C., Delatte, H., Bagny, L., Corbel, V. and Fontenille, D. (2009) Aedes albopictus, an Arbovirus Vector: From the Darkness to the Light. Microbes and Infection, 11, 1177-1185. https://doi.org/10.1016/j.micinf.2009.05.005
Radhakrishnan, A. (2019) Study on Mosquito (Diptera: Culicidae) Diversity in Ernakulam District of the Kerala State, South India. International Journal of Mosquito Research, 6, 1-5.
Xu, C., Xu, J. and Wang, L. (2024) Long-Term Effects of Climate Factors on Dengue Fever over a 40-Year Period. BMC Public Health, 24, Article No. 145. https://doi.org/10.1186/s12889-024-18869-0
WHO (2012) Global Strategy for Dengue Prevention and Control 2012-2020.
https://iris.who.int/bitstream/handle/10665/75303/9789241504034_eng.pdf;
jsessionid=948981ADA757B8530EF273836787F769?sequence=1
Chagas, G.C.L., Rangel, A.R., Noronha, L.M., Veloso, F.C.S., Kassar, S.B., Oliveira, M.J.C., et al. (2022) Risk Factors for Mortality in Patients with Dengue: A Systematic Review and Meta‐Analysis. Tropical Medicine & International Health, 27, 656-668. https://doi.org/10.1111/tmi.13797
Guzman, M.G., Jaenisch, T., Gaczkowski, R., Ty Hang, V.T., Sekaran, S.D., Kroeger, A., et al. (2010) Multi-Country Evaluation of the Sensitivity and Specificity of Two Commercially-Available NS1 ELISA Assays for Dengue Diagnosis. PLOS Neglected Tropical Diseases, 4, e811. https://doi.org/10.1371/journal.pntd.0000811
Chakravarti, A., Kumar, A. and Malik, S. (2011) Detection of Dengue Infection by Combining the Use of an NS1 Antigen Based Assay with Antibody Detection. The Southeast Asian Journal of Tropical Medicine and Public Health, 42, 297-302.
Shu, P. and Huang, J. (2004) Current Advances in Dengue Diagnosis. Clinical and Vaccine Immunology, 11, 642-650. https://doi.org/10.1128/cdli.11.4.642-650.2004
Sapkota, J., Hasan, R., Onsare, R., Arafah, S., Kariuki, S., Shakoor, S., et al. (2022) Comparative Analysis of Commercially Available Typhoid Point-of-Care Tests: Results of a Prospective and Hybrid Retrospective Multicenter Diagnostic Accuracy Study in Kenya and Pakistan. Journal of Clinical Microbiology, 60, e01000-22. https://doi.org/10.1128/jcm.01000-22
Wilson, E.B. (1927) Probable Inference, the Law of Succession, and Statistical Inference. Journal of the American Statistical Association, 22, 209-212. https://doi.org/10.1080/01621459.1927.10502953
Peeling, R.W. and McNerney, R. (2014) Emerging Technologies in Point-of-Care Molecular Diagnostics for Resource-Limited Settings. Expert Review of Molecular Diagnostics, 14, 525-534. https://doi.org/10.1586/14737159.2014.915748
Khattak, A., Khan, S., Ali, I., Gul, A., Khabir, M.N., Javed, B., et al. (2024) Burden and Distribution of Dengue Infection in Pakistan (2000-19): A Review. Brazilian Journal of Biology, 84, e267982. https://doi.org/10.1590/1519-6984.267982
Tabassum, S., Naeem, A., Nazir, A., Naeem, F., Gill, S. and Tabassum, S. (2023) Year-Round Dengue Fever in Pakistan, Highlighting the Surge Amidst Ongoing Flood Havoc and the COVID-19 Pandemic: A Comprehensive Review. Annals of Medicine & Surgery, 85, 908-912. https://doi.org/10.1097/ms9.0000000000000418
Yow, K.-S., Aik, J., Tan, E.Y., Ng, L.-C. and Lai, Y.-L. (2021) Rapid Diagnostic Tests for the Detection of Recent Dengue Infections: An Evaluation of Six Kits on Clinical Speci-mens. PLOS ONE, 16, e0249602. https://doi.org/10.1371/journal.pone.0249602
Shubhanker, M., Choudhari, R. and Harshita, N. (2016) Comparative Evaluation of Validity and Cost-Benefit Analysis of Rapid Diagnostic Test (RDT) Kits in Diagnosis of Dengue Infection Using Composite Reference Criteria: A Cross-Sectional Study from South India. Journal of Vector Borne Diseases, 53, 30-36.
Chong, Z.L., Sekaran, S.D., Soe, H.J., Peramalah, D., Rampal, S. and Ng, C. (2020) Diagnostic Accuracy and Utility of Three Dengue Diagnostic Tests for the Diagnosis of Acute Dengue Infection in Malaysia. BMC Infectious Diseases, 20, Article No. 210. https://doi.org/10.1186/s12879-020-4911-5
Kyaw, A.K., Ngwe Tun, M.M., Naing, S.T., Htet, K.K.K., Htwe, T.T., Khaing, Y.Y., et al. (2019) Evaluation of Commercially Available Three Dengue Rapid Diagnostic Test Kits for Diagnosis of Acute Dengue Virus Infection at the Point-of-Care Setting in Myanmar. Journal of Virological Methods, 273, Article 113724. https://doi.org/10.1016/j.jviromet.2019.113724
Chanama, S., Anantapreecha, S., A-nuegoonpipat, A., Sa-gnasang, A., Kurane, I. and Sawanpanyalert, P. (2004) Analysis of Specific IgM Responses in Secondary Dengue Virus Infections: Levels and Positive Rates in Comparison with Primary Infections. Journal of Clinical Virology, 31, 185-189. https://doi.org/10.1016/j.jcv.2004.03.005
Muller, D.A., Depelsenaire, A.C.I. and Young, P.R. (2017) Clinical and Laboratory Diagnosis of Dengue Virus Infection. The Journal of Infectious Diseases, 215, S89-S95. https://doi.org/10.1093/infdis/jiw649
Frazer, J.L. and Norton, R. (2024) Dengue: A Review of Laboratory Diagnostics in the Vaccine Age. Journal of Medical Microbiology, 73, Article 001833. https://doi.org/10.1099/jmm.0.001833
Fagbami, A.H. and Onoja, A.B. (2018) Dengue Haemorrhagic Fever: An Emerging Disease in Nigeria, West Africa. Journal of Infection and Public Health, 11, 757-762. https://doi.org/10.1016/j.jiph.2018.04.014
