Background: Dengue 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 results: Studies 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.
Conclusion: DENV1 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.