Abstract
BackgroundDengue 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.MethodsThis 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.ResultsThe 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.ConclusionsThe 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.
Highlights
Dengue is an emerging infectious disease that infects up to 390 million people yearly
The excellent agreement between the results tested on capillary, venous, and serum samples in this study demonstrated that all three of them can be used on rapid diagnostic tests (RDT), provided that anticoagulant-coated tool is used for the collection of whole blood specimen
This study discovered that non-structural antigen-1 (NS1)-only assays had higher sensitivity in detecting primary and laboratoryconfirmed dengue, while serology-only assays were better in secondary and presumptive dengue
Summary
Dengue is an emerging infectious disease that infects up to 390 million people yearly. Dengue is an emerging infectious disease endemic to more than 100 tropical countries [1]. An estimate of up to 390 million dengue infections happened in the year 2010 alone, of which only a quarter were detectable [2]. In Malaysia, dengue incidence stood as high as 396.4 cases/100,000 population with case fatality rate ranging from 0.20–0.28% in recent years. In 2015 alone, dengue virus infected up to 120,000 people and caused 336 deaths [4]. Despite an absence of medical treatment to date, early disease recognition and timely intervention with proper fluid management and supportive care can prevent mortality due to dengue infection [5]
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
