Diagnostic Performance of Dengue NS1 Antigen and IgM/IgG Rapid Tests: Systematic Review and Meta-Analysis

Abstract

Background: Dengue virus infection remains a global public health concern where timely diagnosis is essential for clinical management and outbreak surveillance. Objective: This systematic review and meta-analysis evaluated the diagnostic performance of NS1 antigen and IgM/IgG rapid diagnostic tests (RDTs) in dengue-endemic settings. Methods: Following PRISMA 2020 guidelines, electronic databases (PubMed, Scopus, Web of Science, Google Scholar) were searched for contemporary peer-reviewed accuracy studies. Quality and risk of bias were assessed using the QUADAS-2 tool, and 2×2 contingency data were extracted to estimate diagnostic performance. Results: Sixty-five studies met eligibility criteria for qualitative synthesis, while five verified contemporary NS1 RDT studies were selected for quantitative meta-analysis pooling. Across these five studies, reported sensitivity ranged from 73.5% to 100.0%, and specificity ranged from 93.9% to 100.0%. Pooled random-effects estimates demonstrated a robust pooled sensitivity of 81.2% (95% CI: 74.8% – 86.3%) and an exceptionally high pooled specificity of 99.0% (95% CI: 98.1% – 99.6%). Diagnostic performance varied primarily by illness timing, serological status, and reference standard layout. NS1 testing provided peak clinical utility during the early acute phase (Days 1–5), whereas IgM and IgG testing provided critical complementary data during convalescent stages or secondary infections. Conclusion: Overall, contemporary evidence supports NS1 antigen RDTs as dependable point-of-care tools due to their high specificity; however, negative results cannot fully exclude infection. Integrating NS1 with IgM/IgG provides comprehensive diagnostic coverage. Standardized prospective trials reporting raw data are recommended to improve future evidence synthesis.