Abstract
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.
Highlights
Visceral Leishmaniasis (VL) is a severely neglected disease affecting millions of people with high mortality if left untreated
Overall pooled sensitivity and specificity of the rk39 rapid diagnostic tests (RDT) to diagnose VL in Ethiopia were 88.0% and 84.0%, respectively
The sensitivity and specificity of the rk39 RDT commercial test kits were DiaMed: 86.9% and 82.2%, and InBios: 80.0% and 97.4%, respectively
Summary
Visceral 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). The direct agglutination test (DAT) is a pioneer serological test based on the agglutination of a Leishmania promastigote antigen preparation with specific antibodies in patient serum, which result can be interpreted without any reading aid. Rk39 RDT detects antibodies against the 39-amino acid repeat antigens encoded by a kinesin-related gene of the amastigotes stage of the Leishmania infantum [15, 16], is considered to be a good alternative. The rK39 RDTs are simple to perform, costeffective, stable at room temperature, and rapid These immunochromatographic tests are currently widely implemented for the diagnosis of VL in resource-limited countries like Ethiopia [17, 18]. Limitations of rk RDTs are variable specificity, inability to differentiate between current and past infection, not being suitable for treatment effectiveness monitoring [19]
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