Abstract
BackgroundDengue virus (DENV) NS1 antigen detection is regarded as an early diagnostic marker. Accordingly, several studies have evaluated the performance of tests that utilize NS1 capture, but the results of individual studies may be limited due to the restricted sample size of the patients recruited. Therefore, our objective was to perform a meta-analysis of the diagnostic accuracy of two commercial NS1 ELISAs (Panbio and Platelia).Methods and ResultsStudies of interest were found in PubMed, Embase and Google Scholar databases using defined inclusion/exclusion criteria. A total of 30 studies containing 12,105 total enrolled patients were included. The results were as follows: 1) Panbio assays showed low overall performance, sensitivity 66% (95% confidence interval (CI) 61–71), specificity 99% (95% CI 96–100), positive likelihood ratio (LR+) 98 (95% CI 20–464), negative likelihood ratio (LR-) 0.3 (95% CI 0.2–0.4), diagnostic odds ratio (DOR) 289 (95% CI 59–1412); 2) Platelia assays showed high overall performance, sensitivity 74% (95% CI 63–82), specificity 99% (95% CI 97–100), LR+ 175 (95% CI 28–1099), LR- 0.3 (95% CI 0.2–0.4), DOR 663 (95% CI 98–4478). The lowest sensitivity values were for secondary infections (57% [95% CI 47–67] and 66% [95% CI 53–77] for Panbio and Platelia, respectively) and for the detection of DENV4. Regarding clinical manifestations, the sensitivity of Platelia was 69% (95% CI 43–86) and 60% (95% CI 48–70) for fever and dengue hemorrhagic fever, respectively. In addition, the sensitivity of both tests was slightly lower for samples from Southeast Asia and Oceania.ConclusionDENV1 samples gave higher sensitivity results for both tests. We observed that factors negatively influencing the tests, such as the type of infection, geographical origins of samples and viral serotypes, require further investigation to optimize the diagnostic accuracy.
Highlights
Dengue is a pandemic disease that has been neglected but is reemerging, putting approximately three billion people in tropical and subtropical regions at risk of this viral infection [1,2]
We observed that factors negatively influencing the tests, such as the type of infection, geographical origins of samples and viral serotypes, require further investigation to optimize the diagnostic accuracy
After the exclusion criteria were applied, 30 baseline studies remained [25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54], which were included in our meta-analysis because they involved experimental research evaluating the diagnostic accuracy of the Panbio or Platelia kits, which used nonstructural protein 1 (NS1) antigen capture in an indirect ELISA format
Summary
Dengue is a pandemic disease that has been neglected but is reemerging, putting approximately three billion people in tropical and subtropical regions at risk of this viral infection [1,2]. Dengue virus (DENV), genus Flavivirus, is antigenically classified into four serotypes (DENV1-4). DENV is an arbovirus (Arthropod-borne virus) and is increasingly infecting humans, with the incidence of dengue showing a 30-fold increase within the last 50 years [3,4,5,6]. Dengue disease results in a wide clinical spectrum with undifferentiated febrile symptoms, hindering early diagnosis and clinical management. DENV infections can be asymptomatic or present as the classical clinical picture of dengue fever (DF). We will use the classification into DF/dengue hemorrhagic fever (DHF)/or dengue shock syndrome (DSS), since it continues to be widely used [2,7]. Dengue virus (DENV) NS1 antigen detection is regarded as an early diagnostic marker. Our objective was to perform a meta-analysis of the diagnostic accuracy of two commercial NS1 ELISAs (Panbio and Platelia)
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