Diagnostic Accuracy of Rapid Diagnostic Tests Versus Enzyme-Linked Immunosorbent Assay (ELISA) Across Major Infectious Diseases: A Systematic Review and Meta-Analysis.

Rapid diagnostic tests (RDTs) are increasingly used for point-of-care diagnosis of infectious diseases because of their rapid turnaround time and ease of use. However, their diagnostic performance compared with enzyme-linked immunosorbent assay (ELISA) varies across diseases and assay platforms. This systematic review and meta-analysis was conducted according to PRISMA 2020 guidelines. A total of 26 studies were included in the qualitative synthesis, of which 13 datasets from 11 studies with complete 2 × 2 diagnostic data were included in the meta-analysis. Quality assessment was performed using QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies-2). Pooled diagnostic performance was summarized separately for each infection using extracted true-positive (TP), false-positive (FP), true-negative (TN), and false-negative (FN) values; forest plots, an HSROC (Hierarchical Summary Receiver Operating Characteristic model)-style summary visualization, and a Deeks-type funnel plot were generated. The aggregate diagnostic counts were TP = 1,304, FP = 68, TN = 24,301, and FN = 303. Overall, the included datasets showed consistently high specificity (≥96.97%), whereas sensitivity varied widely (25%-100%) across conditions. By target condition, the pooled sensitivity and specificity were human immunodeficiency virus (HIV; 78.6%/99.30%), hepatitis B virus (HBV; 88.2%/99.94%), hepatitis C virus (HCV; 75.7%/99.42%), dengue (97.0%/99.97%), and malaria (100.0%/97.18%). RDTs demonstrated high specificity and good sensitivity compared with ELISA, supporting their role as rapid screening tools, particularly in resource-limited settings. However, heterogeneity across diseases and assay platforms limits generalizability, and confirmatory testing remains important in selected clinical and blood-screening settings.