Serum samples from 75 patients living in Nice, France were retrospectively analyzed. They included patients affected by visceral leishmaniasis (VL; n = 25), asymptomatic carriers (AC; n = 25) and negative controls (n = 25). Each sample was tested using two immunochromatographic tests (ICT; IT LEISH® and TruQuick IgG/IgM®), an indirect fluorescent antibody test (IFAT) and two Western Blotting (WB; LDBio BIORAD® and an in-house method).
Diagnosis of VL with IFAT and TruQuick® showed the highest diagnostic performance parameters. IFAT had 100% sensitivity and specificity, while TruQuick had 96% sensitivity and 100% specificity. Finally, the two tests showed high accuracy (100% for IFAT and 98% for TruQuick) for the AC group. WB LDBio® was the only method able to detect Leishmania latent infection, with a sensitivity of 92%, and a specificity of 100%, with a Negative Predictive Value (NPV) of 93%. This performance is reflected in the high accuracy of the test.
The data obtained with TruQuick® supports its application in the rapid diagnosis of leishmaniasis in endemic areas, a feature not shown by IFAT despite its high diagnostic performance. Regarding the diagnosis of asymptomatic leishmaniasis, the best results were obtained with WB LDBio®, confirming previous studies.
方法:来自居住在尼斯的75名患者的血清样本,法国进行了回顾性分析。他们包括内脏利什曼病患者(VL;n=25),无症状携带者(AC;n=25)和阴性对照(n=25)。每个样品使用两个免疫层析测试(ICT;ITLEISH®和TruQuickIgG/IgM®)进行测试,间接荧光抗体测试(IFAT)和两个蛋白质印迹(WB;LDBioBIORAD®和内部方法)。
结果:使用IFAT和TruQuick®对VL进行诊断显示出最高的诊断性能参数。IFAT具有100%的灵敏度和特异性,而TruQuick的敏感性为96%,特异性为100%。最后,两项测试显示AC组的准确率较高(IFAT为100%,TruQuick为98%).WBLDBio®是唯一能够检测利什曼原虫潜伏感染的方法,灵敏度为92%,和100%的特异性,负预测值(NPV)为93%。这种性能体现在测试的高精度上。
结论:使用TruQuick®获得的数据支持其在流行地区利什曼病的快速诊断中的应用,尽管IFAT具有很高的诊断性能,但该功能并未显示。关于无症状利什曼病的诊断,使用WBLDBio®获得最佳结果,证实了以前的研究。