Department of Human Physiology, School of Medicine, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.
Department of Epidemiology and biostatistics, Institute of public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.
PLoS Negl Trop Dis. 2024 Mar 6;18(3):e0011938. doi: 10.1371/journal.pntd.0011938. eCollection 2024 Mar.
Visceral leishmaniasis (VL), or kala-azar, is a vector-borne tropical disease caused by a group of intracellular hemoflagellate protozoa belonging to the family of Trypanosomatide and the genus Leishmania. The disease is distributed around the world and transmitted via the bite of infected female Phlebotomine sandflies, and there is variation in the diagnostic accuracy. Therefore, this systematic review and meta-analysis aimed to determine the pooled global sensitivity and specificity of the rk-39 test and to evaluate if there is a difference between the different parts of the world.
A systematic review and meta-analysis have been conducted on the diagnostic accuracy of dermoscopy. After setting eligibility criteria, literature was searched in four databases and one searching engine. Articles were screened, critically appraised, and extracted independently by two reviewers, and any disagreements were resolved with the involvement of a third person. The quality of the included studies had been assessed by the Quality Assessment of Diagnostic Accuracy Studies (QUADAS 2) tool. Pooled sensitivity and specificity were determined by bivariate random effect analysis. Heterogeneity was assessed by Higgins's I2, and when it was present, mitigation was conducted by using sensitivity analysis.
A total of 409 studies were identified, and finally 18 articles were eligible for the review with a total sample size of 5, 253. The bivariate random effect meta-analysis of the 7 diagnostic accuracy studies showed a pooled sensitivity of 0.89 (0.76-0.95) and specificity of 0.86 (0.72-0.94). The +LR was 6.32 (95% CI: 2.85-14.02), the-LR was 0.13 (95% CI: 0.06-0.30), and the diagnostic odds ratio (DOR) was 47.8 (95% CI: 11.3-203.2). Abdel-Latif (2018) was both an outlier and influential for sensitivity, and Walter (2011) was both an outlier and influential for specificity, and removing them from sensitivity and specificity, respectively, was beneficial for reducing the heterogeneity.
Rk-39 is found to have highly accurate measures in the diagnosis of visceral leishmaniasis. Both sensitivity and specificity were found to be highly accurate in the diagnosis of leishmaniasis, with a pooled sensitivity of 0.91 (0.88-0.93) and a pooled specificity of 0.89 (0.85-0.91).
As we will use secondary data for the systematic review and meta-analysis, ethical concerns are not necessary.
内脏利什曼病（VL），又称黑热病，是一种由一组属于动基体目和利什曼属的细胞内血鞭毛原生动物引起的热带病。该疾病分布于世界各地，通过感染的雌性白蛉沙蝇的叮咬传播，其诊断准确性存在差异。因此，本系统评价和荟萃分析旨在确定 rk-39 检测的全球汇总灵敏度和特异性，并评估世界不同地区之间是否存在差异。
对皮肤镜检查的诊断准确性进行了系统评价和荟萃分析。设定合格标准后，在四个数据库和一个搜索引擎中搜索文献。由两名评审员独立筛选、批判性评价和提取文章，如果存在分歧，则由第三名评审员解决。通过 Quality Assessment of Diagnostic Accuracy Studies (QUADAS 2) 工具评估纳入研究的质量。通过双变量随机效应分析确定汇总敏感性和特异性。使用 Higgins's I2 评估异质性，如果存在异质性，则通过敏感性分析进行缓解。
共确定了 409 项研究，最终有 18 篇文章符合综述要求，总样本量为 5253 人。对 7 项诊断准确性研究的双变量随机效应荟萃分析显示，汇总敏感性为 0.89（0.76-0.95），特异性为 0.86（0.72-0.94）。+LR 为 6.32（95%CI：2.85-14.02），-LR 为 0.13（95%CI：0.06-0.30），诊断比值比（DOR）为 47.8（95%CI：11.3-203.2）。Abdel-Latif（2018）既是敏感性的异常值，也是敏感性的影响因素，Walter（2011）既是特异性的异常值，也是特异性的影响因素，分别从敏感性和特异性中去除它们有助于降低异质性。
rk-39 在诊断内脏利什曼病方面具有高度准确的测量值。在诊断利什曼病方面，敏感性和特异性均高度准确，汇总敏感性为 0.91（0.88-0.93），汇总特异性为 0.89（0.85-0.91）。
由于我们将使用二次数据进行系统评价和荟萃分析，因此不存在伦理问题。
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