Ayelign Birhanu, Jemal Mohammedamin, Negash Markos, Genetu Meaza, Wondmagegn Tadelo, Zeleke Ayalew Jejaw, Worku Ligabaw, Bayih Abebe Genetu, Shumie Girma, Behaksra Sinknesh Wolde, Fenta Tiruwork, Damte Demekech, Yeshanew Arega, Gadisa Endalamaw
Department of Immunology and Molecular Biology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.
Department of Medical Parasitology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.
BMC Microbiol. 2020 Apr 15;20(1):90. doi: 10.1186/s12866-020-01780-0.
Visceral leishmaniasis in Ethiopia is a re-emerging threat to public health, with increased geographical distribution and number of cases. It is a fatal disease without early diagnosis and treatment; thus, the availability of affordable diagnostic tools is crucial. However, due to delays caused by import regulations, procurement and late delivery of imported test kits, accessibility remains a problem in the control program. Therefore, we aimed to produce and evaluate the performance of an in-house liquid (AQ) direct agglutination test (DAT) antigen.
The AQ-DAT was produced at the Armauer Hansen Research Institute, using Leishmania donovani strain (MHOM/ET/67/L82). Sera from 272 participants; 110 microscopically confirmed cases of VL, 76 apparently healthy and 86 patients who had infectious disease other than VL were tested with AQ-DAT, and standard kits: Freeze-dried DAT (FD-DAT) and rK39. Taking microscopy as a gold standard; the sensitivity and specificity of the AQ-DAT were 97.3 and 98.8%, respectively. It had high degrees of agreement (k > 0.8), with a significant (P < 0.05) correlation compared to microscopy, FD-DAT, and rK39.
Although further standardization is required, the in-house AQ-DAT could improve diagnostic accessibility, minimize intermittent stock outs and strengthen the national VL control program.
在埃塞俄比亚，内脏利什曼病对公共卫生构成了新出现的威胁，其地理分布和病例数都有所增加。这是一种若不早期诊断和治疗就会致命的疾病；因此，有价格可承受的诊断工具至关重要。然而，由于进口法规、采购以及进口检测试剂盒延迟交付所造成的延误，在防控项目中，可及性仍然是一个问题。因此，我们旨在生产并评估一种自制液体（AQ）直接凝集试验（DAT）抗原的性能。
AQ-DAT是在阿姆奥尔·汉森研究所使用杜氏利什曼原虫菌株（MHOM/ET/67/L82）生产的。用AQ-DAT以及标准试剂盒：冻干DAT（FD-DAT）和rK39，对272名参与者的血清进行了检测；其中110例经显微镜检查确诊为内脏利什曼病，76例看似健康，86例患有除内脏利什曼病之外的传染病。以显微镜检查作为金标准；AQ-DAT的敏感性和特异性分别为97.3%和98.8%。与显微镜检查、FD-DAT和rK39相比，它具有高度一致性（k＞0.8），且相关性显著（P＜0.05）。
尽管还需要进一步标准化，但自制的AQ-DAT可提高诊断可及性，尽量减少间歇性缺货情况，并加强国家内脏利什曼病防控项目。
