Abstract：
Leishmaniasis is a major health problem and its diagnosis still represents a challenge. Since consistent evidence on the comparison of serological methods is lacking, our work aims to compare five serological tests for the diagnosis of visceral and asymptomatic leishmaniasis in southern France, a region where leishmaniasis is endemic.
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.
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.
摘要：
背景：利什曼病是一个主要的健康问题，其诊断仍然是一个挑战。由于缺乏关于血清学方法比较的一致证据，我们的工作旨在比较法国南部内脏和无症状利什曼病诊断的五种血清学检查，利什曼病流行的地区。
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。
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。
