Performance of rapid rk39 tests for the diagnosis of visceral leishmaniasis in Ethiopia: a systematic review and meta-analysis

BMC Infectious Diseases

Henk D. F. H. Schallig¹  Yazezew K. Kiros²  Mahmud Abdulkadir³  Dawit Gebreegziabiher Hagos⁴  Dawit Wolday⁵ 

[1] Academic Medical Centre at the University of Amsterdam, Department of Medical Microbiology, Experimental Parasitology Unit, Amsterdam University Medical Centres, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands;College of Health Sciences, School of Medicine, Department of Internal Medicine, Mekelle University, Mekelle, Ethiopia;College of Health Sciences, School of Medicine, Department of Medical Microbiology and Immunology, Mekelle University, Mekelle, Ethiopia;College of Health Sciences, School of Medicine, Department of Medical Microbiology and Immunology, Mekelle University, Mekelle, Ethiopia;Academic Medical Centre at the University of Amsterdam, Department of Medical Microbiology, Experimental Parasitology Unit, Amsterdam University Medical Centres, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands;College of Health Sciences, School of Medicine, Mekelle University, Mekelle, Ethiopia;

关键词: VL;    rk39;    Sensitivity;    Specificity;    Ethiopia;   

DOI  :  10.1186/s12879-021-06826-w

来源: Springer

【 摘 要 】

BackgroundVisceral Leishmaniasis (VL) is a severely neglected disease affecting millions of people with high mortality if left untreated. In Ethiopia, the primary laboratory diagnosis of VL is by using an antigen from a 39-amino acid sequence repeat of a kinesin-related (rK39) of leishmania donovani complex (L. donovani), rapid diagnostic tests (RDT). Different rk39 RDT brands are available with very variable performance and studies from Ethiopia showed a very wide range of sensitivity and specificity. Therefore, a systematic review and meta-analysis were conducted to determine the pooled sensitivity and specificity of rk39 RDT in Ethiopia.MethodPUBMED, EMBASE, and other sources were searched using predefined search terms to retrieve all relevant articles from 2007 to 2020. Heterogeneity was assessed by visually inspecting summary receiver operating curves (SROC), Spearman correlation coefficient (rs), Cochran Q test statistics, inconsistency square (I2) and subgroup analysis. The presence and statistical significance of publication bias were assessed by Egger's test at p < 0.05, and all the measurements showed the presence of considerable heterogeneity. Quality assessment of diagnostic accuracy studies (QUADAS-2) checklists was used to check the qualities of the study.ResultsA total of 664 articles were retrieved, and of this 12 articles were included in the meta-analysis. Overall pooled sensitivity and specificity of the rk39 RDT to diagnose VL in Ethiopia were 88.0% (95% CI 86.0% to 89.0%) and 84.0% (95% CI 82.0% to 86.0%), respectively. The sensitivity and specificity of the rk39 RDT commercial test kits were DiaMed: 86.9% (95% CI 84.3% to 89.1%) and 82.2% (95% CI 79.3% to 85.0%), and InBios: 80.0% (95% CI 77.0% to 82.8%) and 97.4% (95% CI 95.0% to 98.8%), respectively.ConclusionReferring to our result, rk39 RDT considered an essential rapid diagnostic test for VL diagnosis. Besides to the diagnostic accuracy, the features such as easy to perform, quick (10–20 min), cheap, equipment-free, electric and cold chain free, and result reproducibility, rk39 RDT is advisable to remains in practice as a diagnostic test at least in the remote VL endemic localities till a better test will come.

【 授权许可】

CC BY