The Diagnostic Accuracy of Direct Agglutination Test for Serodiagnosis of Human Visceral Leishmaniasis: A Systematic Review with Meta-analysis

Abstract

Background: Direct agglutination test (DAT) as simple, accurate and non-expensive tool that has been used widely for serodiagnosis of visceral leishmaniasis (VL) during the last three decades. We conducted a systematic review and meta-analysis to evaluate the diagnostic accuracy of DAT for serodiagnosis of human VL. Methods: Electronic databases, including MEDLINE (via PubMed), SCOPUS, Web of Science, SID and Mag Iran (two Persian scientific search engines) were searched from December 2004 to April 2019. The study quality was evaluated using the QUADAS checklist. We determined the sensitivities and specificities across studies, calculated positive and negative likelihood ratios (LR+ and LR-), and constructed summary receiver operating characteristic(ROC) curves parameters. Results: Of the 2928 records identified in the mentioned electronic databases and through articles’ reference lists, 25 articles met inclusion criteria and enrolled into the systematic review and among them 22 records were qualified for meta-analysis. The pooled sensitivity and specificity of DAT was 96% [(95% CI, 93–98])and 95% [(95% CI, 88–98]), respectively. The likelihood ratio of a positive test (LR+) was found to be 19.8 [CI95%, 7.6–51.8] and the likelihood ratio of a negative test (LR−) was found to be 0.04 [CI95%, 0.02–0.08]. The combined estimate of the diagnostic odds ratio for DAT was high [454)136-1561]) ].We found that the summary receiver operating characteristic curve (SROC) is positioned near the upper left corner of the curve and the area under curve (AUC) was 0.98 (95% CI, 0.97 to 0.99). Conclusion: Based on our analysis, we find DAT can be considered as valuable tool for the serodiagnosis and seroprevalence of human VL with high sensitivity and specificityrates. As DAT is simple, accurate, non-invasive and efficient serological test, it can be used for serodiagnosis of human VL particularly in endemic areas of the disease.