Accuracy of the SD BIOLINE Dengue Duo for rapid point-of-care diagnosis of dengue

• Authors: Mariana Kikuti, Fundacao Oswaldo Cruz; Jaqueline S. Cruz, Fundacao Oswaldo Cruz; Moreno S. Rodrigues, Fundacao Oswaldo Cruz; Aline S. Tavares, Fundacao Oswaldo Cruz; Igor A. D. Paploski, Universidade Federal da Bahia; Monaise M. O. Silva, Fundacao Oswaldo Cruz; Perla A. Santana, Fundacao Oswaldo Cruz; Laura B. Tauro, Consejo Nacional de Investigaciones Científicas y Técnicas; Greice A. O. F. Silva, Fundacao Oswaldo Cruz; Gubio S. Campos, Universidade Federal da Bahia; Joselio M. G. Araújo, Universidade Federal do Rio Grande do Norte; Uriel Kitron, Emory University; Mitermayer G. Reis, Fundacao Oswaldo Cruz; Guilherme S. Ribeiro, Fundacao Oswaldo Cruz
• Journal Title: PLoS ONE
• Volume: Volume 14, Number 3
• Publisher: Public Library of Science | 2019-03-01, Pages e0213301-e0213301
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1371/journal.pone.0213301
• Subjects: Health Sciences, Pathology; Health Sciences, Epidemiology; Biology, Virology
• Keywords: Rapid diagnostic tests; medical treatment; non-structural 1 dengue virus antigen; IgM; IgG; antibodies; Salvador; SD BIOLINE Dengue Duo RDT; acute-phase sera

Abstract

Background Rapid diagnosis tests (RDTs) are easy to carry out, provide fast results, and could potentially guide medical treatment decisions. We investigated the performance of a commercially available RDT, which simultaneously detects the non-structural 1 (NS1) dengue virus (DENV) antigen, and IgM and IgG DENV antibodies, using representative serum samples from individuals in a dengue endemic area in Salvador, Brazil. Methodology/Principal findings We evaluated the accuracy of the SD BIOLINE Dengue Duo RDT (Abbott, Santa Clara, USA; former Alere Inc, Waltham, USA) in a random collection of sera. Samples included acute-phase sera from 246 laboratory-confirmed dengue cases and 108 non-dengue febrile patients enrolled in a surveillance study for dengue detection, 73 healthy controls living in the same surveillance community, and 73 blood donors. RDT accuracy was blindly assessed based on the combined results for the NS1 and the IgM test components. The RDT sensitivity was 46.8% (38.6% for the NS1 component and 13.8% for the IgM component). Sensitivity was greater for samples obtained from patients with secondary DENV infections (49.8%) compared to primary infections (31.1%) (P: 0.02) and was also influenced by the result in the confirmatory dengue diagnostic test, ranging from 39.7% for samples of cases confirmed by IgM-ELISA seroconversion between paired samples to 90.4% for samples of cases confirmed by a positive NS1-ELISA. The RDT specificity was 94.4% for non-dengue febrile patients, 87.7% for the community healthy controls, and 95.9% for the blood donors. Conclusions/Significance The SD BIOLINE Dengue Duo RDT showed good specificities, but low sensitivity, suggesting that it may be more useful to rule in than to rule out a dengue diagnosis in dengue endemic regions.