Abstract
BackgroundRapid 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 findingsWe 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/SignificanceThe 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.
Highlights
Dengue virus (DENV) is estimated to infect up to 390 million people each year, of which 96 million develop clinical disease [1]
Accuracy of the SD BIOLINE Dengue Duo rapid diagnosis test groups: i) dengue cases confirmed by laboratory reference tests during a surveillance study for acute febrile illness (AFI) (N: 246 samples); ii) non-dengue AFI controls enrolled in the same surveillance study (N: 108 samples); iii) presumably healthy individuals living in the same community where the surveillance study was conducted (N: 73 samples); and iv) blood donors (N: 73 samples) (Fig 1)
Of the 246 laboratory-confirmed dengue patients whose samples were selected for this study, 181 (73.6%) were reverse-transcription polymerase chain reaction (RT-PCR) positive, 72 (29.3%) were non-structural 1 (NS1)-enzyme-linked immunosorbent assays (ELISAs) positive, and 151 (61.4%) presented IgM-ELISA seroconversion between the acute- and convalescent-phase samples
Summary
Dengue virus (DENV) is estimated to infect up to 390 million people each year, of which 96 million develop clinical disease [1]. Several laboratory exams for dengue diagnosis are commercially available, including molecular tests for detection of viral DENV RNA by reverse-transcription polymerase chain reaction (RT-PCR), enzyme-linked immunosorbent assays (ELISAs) for detection of non-structural 1 (NS1) DENV protein during the viremic phase and detection of DENV IgM antibodies after the viremic phase, among many others. Molecular tests and ELISAs are typically time-consuming and require laboratory infrastructure not commonly found in outpatient health units. They are of limited use for rapid evaluation of patients suspected of dengue and often do not help guiding medical treatment in such settings. 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
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