Rapid diagnostic test (Leptocheck-WB) for detection of acute leptospirosis: a meta-analysis of diagnostic accuracy

The majority of leptospirosis is subclinical or mild self-limiting systemic illness. A rapid and accurate diagnostic test for the detection of leptospirosis is essential to prevent disease progression from acute non-severe illness to potentially fatal infection. Rapid diagnostic tests (RDTs) recognized as point-of-care (PoC) tests may support clinical decision-making in resource-poor settings. We aimed to assess the accuracy of PoC (Leptocheck-WB) for the detection of acute leptospirosis by meta-analysis of data from eligible studies. This study adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis for Diagnostic Test Accuracy (PRISMA-DTA) guideline. The pooling of data was done only when there were two or more studies that used a particular type of reference test. A total of ten studies (n = 5369) were identified. The majority (70%) were from the Asian region. Using microscopic agglutination test (MAT) as reference test, the pooled sensitivity (0.75, 95% CI: 0.64 to 0.84, 10 studies, I2: 85.9%) and specificity (0.87, 95% CI: 0.77 to 0.94, 10 studies, I2: 97.37%) of Leptocheck-WB in the detection of leptospirosis were moderate. With the use of enzyme-linked immunosorbent assay (ELISA) reference test, the pooled sensitivity 0.85 (95% CI: 0.79 to 0.9, 4 studies, I2: 27.49%) and specificity 0.79 (95% CI: 0.71 to 0.85, 4 studies, I2: 58.9%) of Leptocheck-WB were also moderate. Diagnostic odds ratio of Leptocheck-WB with MAT (21, 95% CI: 10-44) or with ELISA as reference test (21, 95% CI: 9-46) showed an acceptable level of accuracy. Meta-regression analysis showed methodological quality of studies (p: 0.06) and study design (p: 0.09) were potential factors that affected the accuracy of Leptocheck-WB test. Findings suggest that Leptocheck-WB has a moderate level of acceptance for detection of acute leptospirosis. Further confirmation with large-sampled, prospectively designed studies using the same samples for evaluating test accuracy is recommended.