Rezaei Zahra, Pourabbas Bahman, Kühne Vera, Pourabbas Parham, Büscher Philippe
Professor Alborzi Clinical Microbiology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
J Trop Med. 2022 Apr 11;2022:3569704. doi: 10.1155/2022/3569704. eCollection 2022.
To evaluate the diagnostic performance of five alternative serodiagnostic tests, serum samples from 100 confirmed visceral leishmaniasis (VL) patients, 197 healthy endemic individuals, and 58 non-VL patients living in southern Iran were compared. The VL patients were defined as individuals with a positive result of the immunofluorescent antibody test (IFAT), having clinical signs and symptoms and appropriate response to treatment. The index tests were two direct agglutination tests, DAT-ITM (Institute of Tropical Medicine, Antwerp, Belgium) and DAT-KIT (Royal Tropical Institute, Amsterdam, The Netherlands), and three rapid diagnostic tests (RDTs), Kalazar Detect (InBios International Inc., USA), IT Leish (Bio-Rad, catalog 710124), and Leishmania test (Cypress Diagnostic Company, Belgium). Sensitivities of DAT-ITM and DAT-KIT were low, respectively, 56% and 59%, while specificities were acceptable, respectively, 98% and 93%. Observed sensitivities and specificities of RDTs were higher (71%, 81%, 70% and 99%, 99%, 98% for Kalazar Detect, IT Leish, and Leishmania test, respectively). Even with a maximum sensitivity of 81%, RDTs missed almost one-fifth of VL patients that were positive in IFAT. We conclude that RDTs in VL patients do not possess adequate performance in southern Iran and require some improvement, but they can still be helpful in the diagnosis and screening of the disease in this region due to their high specificity and speed.
为评估五种替代血清学诊断检测方法的诊断性能,对来自伊朗南部的100例确诊内脏利什曼病(VL)患者、197例健康流行区个体和58例非VL患者的血清样本进行了比较。VL患者定义为免疫荧光抗体试验(IFAT)结果呈阳性、有临床体征和症状且对治疗有适当反应的个体。指标检测方法为两种直接凝集试验,即DAT-ITM(比利时安特卫普热带医学研究所)和DAT-KIT(荷兰阿姆斯特丹皇家热带研究所),以及三种快速诊断检测(RDT),即黑热病检测(美国InBios International公司)、IT利什曼检测(伯乐公司,产品目录710124)和利什曼原虫检测(比利时赛普拉斯诊断公司)。DAT-ITM和DAT-KIT的敏感性较低,分别为56%和59%,而特异性尚可,分别为98%和93%。观察到的RDT的敏感性和特异性较高(黑热病检测、IT利什曼检测和利什曼原虫检测的敏感性分别为71%、81%、70%,特异性分别为99%、99%、98%)。即使RDT的最大敏感性为81%,仍有近五分之一IFAT呈阳性的VL患者被漏检。我们得出结论,在伊朗南部,RDT对VL患者的诊断性能不足,需要改进,但由于其高特异性和速度,它们在该地区疾病的诊断和筛查中仍可能有帮助。
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