检测特异抗体胶体金免疫层析试条诊断内脏利什曼病患者现场评价

目的 在现场评价检测内脏利什曼病特异抗体的胶体金免疫层析试条诊断内脏利什曼病患者的效果。方法 2013年采集动物源型内脏利什曼病流行区(四川省、甘肃省)和人源型内脏利什曼病流行区(新疆喀什市)疾病预防控制中心门诊就诊的病人血样和骨髓样本,用镜检法、内脏利什曼病试条和rK39试条进行平行测试,以镜检法为金标准,比较两种试条法检测的敏感性和特异性有无差异。结果 内脏利什曼病试条和rK39试条检测镜检确诊的97例内脏利什曼病患者的敏感性分别为98.87%(96/97),97.94%(95/97),二者无统计学差异(χ²=0.34,P>0.05)。两种试条检测非内脏利什曼病病例145例, 均有2例假阳性反应,特异性为98.62(143/145)。对来自动物源型内脏利什曼病流行区和人源型内脏利什曼病流行区的内脏利什曼病患者分别统计阳性率,结果显示内脏利什曼病试条和rK39试条法检测动物源型和人源型流行区的内脏利什曼病患者血样之间阳性率的差异均无统计学意义(χ²=0.22 /0.01,P>0.05)。两种试条法检测动物源型和人源型内脏利什曼病流行区非内脏利什曼病患者血样之间特异性的差异也均无统计学意义(χ²=0.29,P>0.05)。结论 快速检测内脏利什曼病的胶体金免疫层析试条适用于检测动物源型内脏利什曼病流行区患者血样中的特异性抗体。

Evaluation of colloid gold labeled immunochromatographic strip test for rapid detection of canine Leishmanial infection in China

We evaluated a colloid gold immunochromatographic strip test(ICT) developed by our laboratory for detection of human visceral leishmaniasis in field. The human blood and bone marrow samples from the zoonotic visceral leishmaniasis endemic areas(Sichun and Gansu provinces) and a anthroponotic visceral leishmaniasis endemic area(Kashi, Xinjiang) of suspected visceral leishmaniasis were collected and subjected to be detected by the microscopy, ICT and rK39. Detection results of the ICT were compared with that of the rK39 and then compared with microscopy findings(taken as a golden standard). It was found that the positive detection rates of ICT and rK39 were 98.87%(96/97) and 97.94%(95/97), respectively. There was no statistical difference in the sensitivity between ICT and rK39(χ²=0.34, P>0.05). Detection on 145 blood samples of patients with non-visceral leishmaniasis showed both specificities of 98.62(143/145) by the ICT and rK39. There was no statistical difference in the sensitivity between samples from the zoonotic visceral leishmaniasis endemic areas and the anthroponotic visceral leishmaniasis endemic area by the ICT(χ²=0.22, P>0.05). It is evident that the ICT for detection the leishmanial specific antibody of human peripheral blood specimens is proved to be a reliable method.