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Diagnostic accuracy and utility of three dengue diagnostic tests for the diagnosis of acute dengue infection in Malaysia.

ABSTRACT: BACKGROUND:Dengue is an emerging infectious disease that infects up to 390 million people yearly. The growing demand of dengue diagnostics especially in low-resource settings gave rise to many rapid diagnostic tests (RDT). This study evaluated the accuracy and utility of ViroTrack Dengue Acute - a new biosensors-based dengue NS1 RDT, SD Bioline Dengue Duo NS1/IgM/IgG combo - a commercially available RDT, and SD Dengue NS1 Ag enzyme-linked immunosorbent assay (ELISA), for the diagnosis of acute dengue infection. METHODS:This prospective cross-sectional study consecutively recruited 494 patients with suspected dengue from a health clinic in Malaysia. Both RDTs were performed onsite. The evaluated ELISA and reference tests were performed in a virology laboratory. The reference tests comprised of a reverse transcription-polymerase chain reaction and three ELISAs for the detection of dengue NS1 antigen, IgM and IgG antibodies, respectively. The diagnostic performance of evaluated tests was computed using STATA version 12. RESULTS:The sensitivity and specificity of ViroTrack were 62.3% (95%CI 55.6-68.7) and 95.0% (95%CI 91.7-97.3), versus 66.5% (95%CI 60.0-72.6) and 95.4% (95%CI 92.1-97.6) for SD NS1 ELISA, and 52.4% (95%CI 45.7-59.1) and 97.7% (95%CI 95.1-99.2) for NS1 component of SD Bioline, respectively. The combination of the latter with its IgM and IgG components were able to increase test sensitivity to 82.4% (95%CI 76.8-87.1) with corresponding decrease in specificity to 87.4% (95%CI 82.8-91.2). Although a positive test on any of the NS1 assays would increase the probability of dengue to above 90% in a patient, a negative result would only reduce this probability to 23.0-29.3%. In contrast, this probability of false negative diagnosis would be further reduced to 14.7% (95%CI 11.4-18.6) if SD Bioline NS1/IgM/IgG combo was negative. CONCLUSIONS:The performance of ViroTrack Dengue Acute was comparable to SD Dengue NS1 Ag ELISA. Addition of serology components to SD Bioline Dengue Duo significantly improved its sensitivity and reduced its false negative rate such that it missed the fewest dengue patients, making it a better point-of-care diagnostic tool. New RDT like ViroTrack Dengue Acute may be a potential alternative to existing RDT if its combination with serology components is proven better in future studies.

SUBMITTER: Chong ZL

PROVIDER: S-EPMC7069157 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Diagnostic accuracy and utility of three dengue diagnostic tests for the diagnosis of acute dengue infection in Malaysia.

Chong Zhuo Lin ZL Sekaran Shamala Devi SD Soe Hui Jen HJ Peramalah Devi D Rampal Sanjay S Ng Chiu-Wan CW

BMC infectious diseases 20200312 1

<h4>Background</h4>Dengue is an emerging infectious disease that infects up to 390 million people yearly. The growing demand of dengue diagnostics especially in low-resource settings gave rise to many rapid diagnostic tests (RDT). This study evaluated the accuracy and utility of ViroTrack Dengue Acute - a new biosensors-based dengue NS1 RDT, SD Bioline Dengue Duo NS1/IgM/IgG combo - a commercially available RDT, and SD Dengue NS1 Ag enzyme-linked immunosorbent assay (ELISA), for the diagnosis of ...[more]

PMID: 32164538

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Project description:IntroductionRapid diagnostic tests (RDTs) were evaluated, in this paper, for their utility as a reliable test, using resource-constrained studies. In most studies, NS1 antigen and immunoglobulin M (IgM)-based immunochromatographic tests (ICTs) were considered for acute phase detection. We aimed to evaluate the diagnostic accuracy of NS1, IgM, and NS1/IgM-based ICTs to detect acute dengue virus (DENV) infection in dengue-endemic regions.MethodsStudies were electronically identified using the following databases: MEDLINE, Embase, Cochrane Library, Web of Science, and CINAHL Plus. Keywords including dengue, rapid diagnostic test, immunochromatography, sensitivity, specificity, and diagnosis were applied across databases. In total, 15 studies were included. Quality assessment of the included studies was performed using the QUADAS-2 tool. All statistical analyses were conducted using RevMan, MedCalc, and SPSS software.ResultsThe studies revealed a total of 4135 individuals, originating largely from the Americas and Asia. The prevalence of DENV cases was 53.8%. Pooled sensitivities vs. specificities for NS1 (only), IgM (only) and combined NS1/IgM were 70.97% vs. 94.73%, 40.32% vs. 93.01%, and 78.62% vs. 88.47%, respectively. Diagnostic odds ratio (DOR) of DENV for NS1 ICTs was 43.95 (95% CI: 36.61-52.78), for IgM only ICTs was 8.99 (95% CI: 7.25-11.16), and for NS1/IgM ICTs was 28.22 (95% CI: 24.18-32.95). ELISA ICTs yielded a DOR of 21.36, 95% CI: 17.08-26.741. RT-PCR had a DOR of 40.43, 95% CI: 23.3-71.2. Heterogeneity tests for subgroup analysis by ICT manufacturers for NS1 ICTs revealed an χ2 finding of 158.818 (df = 8), p < 0.001, whereas for IgM ICTs, the χ2 finding was 21.698 (df = 5), p < 0.001.ConclusionNS1-based ICTs had the highest diagnostic accuracy in acute phases of DENV infection. Certain factors influenced the pooled sensitivity, including ICT manufacturers, nature of the infection, reference method (RT-PCR), and serotypes. Prospective studies may examine the best strategy for incorporating ICTs for dengue diagnosis.

Dataset Information

Diagnostic accuracy and utility of three dengue diagnostic tests for the diagnosis of acute dengue infection in Malaysia.

Publications

Diagnostic accuracy and utility of three dengue diagnostic tests for the diagnosis of acute dengue infection in Malaysia.

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