Abstract
Dengue necessitates accurate diagnosis. Rapid tests such as Bioline™ DENGUE DUO have gained traction, but validation in specific populations is essential. This study aimed to evaluate the performance of the Bioline™ test, alongside assessing the socio-epidemiological profile of symptomatic patients in a Brasília Military Hospital. The serum of 404 symptomatic patients was analyzed by the Bioline™ DENGUE DUO test, followed by Dengue virus detection and discrimination of the four serotypes by RT-qPCR. Accuracy was assessed using parameters including sensitivity (S), specificity (E), positive and negative predictive values (PPV and NPV), and positive (RV +) and negative (RV-) likelihood ratios. The NS1 component exhibited a sensitivity of 70.37%, a specificity of 97.30%, and an overall efficiency of 90.10% when compared to RT-qPCR as the gold standard. The IgM component demonstrated a sensitivity of 26.85%, a specificity of 89.53%, and an overall efficiency of 72.77% when compared to RT-qPCR as the gold standard. The IgG component demonstrated a sensitivity of 23.15%, a specificity of 68.92%, and an overall efficiency of 56.68% when compared to RT-qPCR as the gold standard. Several rapid tests are commercially available. However, considering variations across regions and demographic groups, it is important to question their accuracy in specific populations. Rapid tests are important screening tools, but they can have limitations for the certainty of diagnosis. Bioline™ DENGUE DUO displayed good specificity, but sensitivity was slightly below optimal levels. While helpful for confirming dengue, improvements are needed to effectively rule out the disease.
Similar content being viewed by others
Data availability
The data supporting the results of this study will be made available by the corresponding author upon reasonable request.
References
Mustafa MS, Rasotgi V, Jain S, Gupta V (2015) Discovery of fifth serotype of dengue virus (DENV-5): a new public health dilemma in dengue control. Med J Armed Forces India 71(1):67–70. https://doi.org/10.1016/j.mjafi.2014.09.011
Guzman MG (2004) Dengue diagnosis, advances and challenges. Int J Infect 8(2):69–80. https://doi.org/10.1016/j.ijid.2003.03.003pubmed.ncbi.nlm.nih.gov/14732325
Braga IA, Valle D (2007) Aedes aegypti: histórico do controle no Brasil. Epidemiol Serv Saude 16(2):113–118. https://doi.org/10.5123/S1679-49742007000200006
Ministério da Saúde (MS). Dengue 2022 [cited 2022 Sep 19]. Available from: https://www.gov.br/saude/pt-br/assuntos/saude-de-a-a-z/d/dengue/dengue
Word Health Organization (WHO) Dengue: diagnosis, treatment, prevention and control 2009. OMS/HTM/NTD/DEN/2009.1. ISBN:978 92 4 154787 1. Available from: https://www.who.int/publications/i/item/9789241547871. Accessed 18 Oct 2022
Osorio L, Ramirez M, Bonelo A, Villar LA, Parra B (2010) Comparison of the diagnostic accuracy of commercial NS1-based diagnostic tests for early dengue infection. Virol J 7:361. https://doi.org/10.1186/1743-422X-7-361
Koczula KM, Gallotta A (2016) Lateral flow assays. Essays Biochem 60(1):111–120. https://doi.org/10.1042/EBC20150012
De Curcio JS, Salem-Izacc SM, Neto LMP, Nunes EB, Anunciação CE, Silveira-Lacerda EP (2022) Detection of Mayaro virus in Aedes aegypti mosquitoes circulating in Goiania-Goias-Brazil. Microbes Infect 24(4):104948. https://doi.org/10.1016/j.micinf.2022.104948
Organização Mundial da Saúde e UNICEF/PNUD/Banco Mundial/Programa Especial da OMS para Pesquisa e Treinamento em Doenças Tropicais Manual de manejo clínico da dengue (2012). Available from: https://apps.who.int/iris/handle/10665/76887. Accessed 20 Nov 2022
Andries AC, Duong V, Ong S et al (2016) Avaliação do desempenho de seis kits comerciais desenvolvidos para detecção de dengue NS1 e anti-dengue IgM, IgG e IgA em amostras clínicas de urina e saliva. BMC Infect Dis 16:201. https://doi.org/10.1186/s12879-016-1551-x
Martins MMF, Almeida AMF de L, Fernandes NDR, Silva LS (2016) Análise dos aspectos epidemiológicos da dengue na microrregião de saúde de Salvador, Bahia, no período de 2007 a 2014. Rev Espaço Para Saúde 16(4):64–73. Available from: https://pesquisa.bvsalud.org/portal/resource/pt/biblio-834521. Accessed 3 Oct 2022
Roque ACM, dos Santos PFBB, de Medeiros ER (2016) Perfil Epidemiológico da Dengue no Município de Natal e Região Metropolitana no Período de 2007 A 2012. Rev Ciênc Plural 1(3):51–61. Available from: https://periodicos.ufrn.br/rcp/article/view/8582. Accessed 3 Oct 2022
Menezes AMF, Almeida KT, de Amorim A dos S, Lopes CMR (2021) Perfil epidemiológico da dengue no Brasil entre os anos de 2010 a 2019 / Epidemiological profile of dengue in Brazil between 2010 and 2019. Braz J Hea Rev 4(3): 13047–58. Available from: https://ojs.brazilianjournals.com.br/ojs/index.php/BJHR/article/view/31260. Accessed 3 Oct 2022
Lima JRC, Rouquayrol MZ, Callado MRM, Guedes MIF, Pessoa C (2012) Interpretation of the presence of IgM and IgG antibodies in a rapid test for dengue: analysis of dengue antibody prevalence in Fortaleza City in the 20th year of the epidemic. Rev Soc Bras Med Trop 45(2):163–7. https://doi.org/10.1590/s0037-86822012000200005
Muller DA, Young PR (2013) The flavivirus NS1 protein: molecular and structural biology, immunology, role in pathogenesis and application as a diagnostic biomarker. Antiviral Res 98(2):192–208. https://doi.org/10.1016/j.antiviral.2013.03.008
SD BIOLINE Dengue Duo Simultaneous Dengue NS1 Ag & IgG/IgM Ab test. Brochure. [cited 2024 Feb 20]. Available from: https://maxanim.com/content/abbott/sd-bioline-dengue-duo.pdf
Andries AC, Duong V, Ngan C, Ong S, Huy R, Sroin KK et al (2012) field evaluation and impact on clinical management of a rapid diagnostic kit that detects dengue NS1, IgM and IgG. PLoS Negl Trop Dis 6(12):e1993. https://doi.org/10.1371/journal.pntd.0001993
Blacksell SD, Jarman RG, Bailey MS, Tanganuchitcharnchai A, Jenjaroen K, Gibbons RV et al (2011) Evaluation of six commercial point-of-care tests for diagnosis of acute dengue infections: the need for combining NS1 antigen and IgM/IgG antibody detection to achieve acceptable levels of accuracy. Clin Vaccine Immunol 18(12):2095–2101. https://doi.org/10.1128/CVI.05285-11
Kikuti M, Cruz JS, Rodrigues MS, Tavares AS, Paploski IAD, Silva MMO et al (2019) Accuracy of the SD BIOLINE Dengue Duo for rapid point-of-care diagnosis of dengue. PLoS ONE 14(3):e0213301. https://doi.org/10.1371/journal.pone.0213301
Prado PS, Almeida Júnior JTD, Abreu LT, Silva CG, Souza LDC, Gomes MC, Mendes LMT, Santos EMD, Romero GAS (2018) Validation and reliability of the rapid diagnostic test “SD Bioeasy Dengue Duo” for dengue diagnosis in Brazil: a phase III study. Mem Inst Oswaldo Cruz 113(8):e170433. https://doi.org/10.1590/0074-02760170433
Schulz KF, Grimes DA (2005) Sample size calculations in randomised trials: mandatory and mystical. Lancet 365:1348–1353. https://doi.org/10.1016/S0140-6736(05)61034-3
Duong V, Ly S, Lorn Try P, Tuiskunen A, Ong S, Chroeung N, Buchy P (2011) Clinical and virological factors influencing the performance of a NS1 antigen-capture assay and potential use as a marker of dengue disease severity. PLoS Negl Trop Dis 5(7):e1244. https://doi.org/10.1371/journal.pntd.0001244
Korhonen EM, Huhtamo E, Virtala AM, Kantele A, Vapalahti O (2014) Approach to non-invasive sampling in dengue diagnostics: exploring virus and NS1 antigen detection in saliva and urine of travelers with dengue. J Clin Virol 61:353–358. https://doi.org/10.1016/j.jcv.2014.08.021
Humaidi M, Tien WP, Yap G, Chua CR, Ng LC (2021) Non-invasive dengue diagnostics—the use of saliva and urine for different stages of the illness. Diagnostics 11:1345. https://doi.org/10.3390/diagnostics11081345
Caraballo E, Poole-Smith B, Tomashek K, Torres B, Alvarado-Domenech L, Lorenzi O et al (2020) The detection of anti-dengue virus IgM in urine in participants enrolled in an acute febrile illness study in Puerto Rico. PLoS Negl Trop Dis 14(1):e0007971. https://doi.org/10.1371/journal.pntd.0007971
Funding
This work was funded by the Program of Academic Cooperation in National Defense (PROCAD), Coordination for the Improvement of Higher Education Personnel (CAPES), and National Research Council (CNPq).
Author information
Authors and Affiliations
Contributions
All authors contributed to the study conception and design. Material preparation, sample assembly, data collection, analysis and the first version of the manuscript were carried out by Leani F. Gomes. Review, formatting and textual standardization were carried out by Júlia. V Mundim, Lívia do C Silva, Juliana de Curcio, Adriano Roberto V. de Sousa, Marco Tulio Zapata, Carlos Eduardo Anunciação, Juliana R. do Carmo and Elisângela de P. Silveira-Lacerda. All authors commented on previous versions of the manuscript and approved the final manuscript.
Corresponding author
Ethics declarations
Ethical approval
In accordance with CNS Resolution 466/2012, precautions were taken to preserve the anonymity of the personal data collected. This study is related to the research project “Implementation of a sentinel laboratory for arbovirus surveillance at Armed Forces Hospital” submitted and approved by the Research Ethics Committee of the Federal University of Goias (No. 4.342.314) and to the HFA (No. 4.618.807).
Informed consent
Informed consent was obtained from all study participants by the HFA Research laboratory, and samples were packaged and processed anonymously with internal codes as agreed.
Competing interest
The author reports no financial interests or other conflicts of interest in this work.
Additional information
Responsible Editor: Mauricio Nogueira
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Supplementary Information
Below is the link to the electronic supplementary material.
Rights and permissions
Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
About this article
Cite this article
Gomes, L.F., Mundim, J.V., do Carmo Silva, L. et al. Diagnostic performance of the bioline dengue duo rapid test on symptomatic patients assisted at Armed Forces Hospital (Hfa) in Brasília, Brazil. Braz J Microbiol (2024). https://doi.org/10.1007/s42770-024-01351-9
Received:
Accepted:
Published:
DOI: https://doi.org/10.1007/s42770-024-01351-9