背景:骨髓的寄生虫学调查,脾或淋巴结吸引是诊断内脏利什曼病(VL)的金标准。然而,这种侵入性测试需要熟练的临床和实验室人员以及足够的设施,灵敏度因使用的组织而异。直接凝集测试(DAT)是一种血清学测试,不需要专业人员,只需要最少的培训。虽然以前的荟萃分析显示,当使用寄生虫学作为诊断参考测试时,DAT具有很高的敏感性和特异性,与其他诊断技术相比,DAT的荟萃分析,如PCR和ELISA,越来越多地用于临床和研究环境,还没有完成。
方法:我们进行了系统回顾,以确定DAT与所有可用的人VL实验室诊断测试相比的诊断性能。我们搜索了包括Medline在内的电子数据库,Embase,全球卫生,Scopus,WoS科学引文索引,WileyCochrane中央控制试验登记册,非洲信息,LILACS和WHO全球指数。三名独立审核员筛选了报告,并从符合条件的研究中提取了数据。荟萃分析评估了DAT的诊断敏感性和特异性。
结果:在筛选的987个标题中,选择358个进行完整数据提取,其中78个包括在分析中,报告了来自19个国家的32,822名参与者。研究包括在1987-2020年之间进行。与任何其他测试相比,使用血清和DAT进行的研究的荟萃分析显示,合并敏感性为95%(95%CrI90-98%),合并特异性为95%(95%CrI88-98%)。当分别分析时,冷冻干燥的DAT和液体DAT的结果相似。HIV阳性患者的敏感性较低(90%,CrI59-98%),有症状患者的特异性较低(70%,CrI43-89%)。当比较不同的地理区域时,最低的中位数敏感度(89%,CrI67-97%)在西亚(五项研究)。
结论:本系统综述和荟萃分析证明了DAT诊断VL的高估计合并敏感性和特异性,尽管不同患者组和地理位置的敏感性和特异性较低.这篇综述强调了DAT方法和准备工作缺乏标准化,以及缺乏一些重要地理位置的数据。未来良好报道的研究可以提供更好的证据,为不同患者人群和用例的测试实施提供依据。
■CRD42021240830。
BACKGROUND: Parasitological investigation of bone marrow, splenic or lymph node aspirations is the gold standard for the diagnosis of visceral leishmaniasis (VL). However, this invasive test requires skilled clinical and laboratory staff and adequate facilities, and sensitivity varies depending on the tissue used. The direct agglutination test (DAT) is a serological test that does not need specialised staff, with just minimal training required. While previous meta-analysis has shown DAT to have high sensitivity and specificity when using parasitology as the reference test for diagnosis, meta-analysis of DAT compared to other diagnostic techniques, such as PCR and ELISA, that are increasingly used in clinical and research settings, has not been done.
METHODS: We conducted a systematic
review to determine the diagnostic performance of DAT compared to all available tests for the laboratory diagnosis of human VL. We searched electronic databases including Medline, Embase, Global Health, Scopus, WoS Science Citation Index, Wiley Cochrane Central Register of Controlled Trials, Africa-Wide Information, LILACS and WHO Global Index. Three independent reviewers screened reports and extracted data from eligible studies. A meta-analysis estimated the diagnostic sensitivity and specificity of DAT.
RESULTS: Of 987 titles screened, 358 were selected for full data extraction and 78 were included in the analysis, reporting on 32,822 participants from 19 countries. Studies included were conducted between 1987-2020. Meta-analysis of studies using serum and DAT compared to any other test showed pooled sensitivity of 95% (95%CrI 90-98%) and pooled specificity of 95% (95%CrI 88-98%). Results were similar for freeze-dried DAT and liquid DAT when analysed separately. Sensitivity was lower for HIV-positive patients (90%, CrI 59-98%) and specificity was lower for symptomatic patients (70%, CrI 43-89%). When comparing different geographical regions, the lowest median sensitivity (89%, CrI 67-97%) was in Western Asia (five studies).
CONCLUSIONS: This systematic
review and meta-analysis demonstrates high estimated pooled sensitivity and specificity of DAT for diagnosis of VL, although sensitivity and specificity were lower for different patient groups and geographical locations. This
review highlights the lack of standardisation of DAT methods and preparations, and the lack of data from some important geographical locations. Future well-reported studies could provide better evidence to inform test implementation for different patient populations and use cases.
UNASSIGNED: CRD42021240830.