Monno Rosa, Giannelli Giorgia, Rizzo Caterina, De Vito Danila, Fumarola Luciana
Department of Internal Medicine & Public Health, Unit of Hygiene, School of Medicine, University of Bari, Policlinico, Piazza G. Cesare 11, 70124 Bari, Italy.
Future Microbiol. 2009 Mar;4(2):159-70. doi: 10.2217/17460913.4.2.159.
A new recombinant K39 immunochromatographic test (ICT) was compared with the immunofluorescent antibody assay (IFA) for the rapid serological diagnosis of visceral leishmaniasis (VL) in Apulia, Southern Italy. A total of 264 individuals were tested, including 19 patients with VL (three of which were HIV positive), 67 individuals with suspected VL, 40 healthy controls and 138 patients with other diseases. The ICT was positive in all 19 patients with VL and negative in sera from the remaining individuals. Both the sensitivity and specificity of ICT was 100%. The ICT also worked well in HIV-Leishmania co-infected patients. Antibodies to Leishmania detected by the IFA and ICT remained at detectable levels for up to 12-24 months. A positive reaction by the ICT was detectable at a serum dilution of up to 1:20,480, indicating that a strong immunoresponse is mounted against the recombinant K39 antigen. In conclusion, the ICT is highly sensitive, specific, rapid, noninvasive and cost effective (euro8.43 for ICT and euro12 for IFA) in the diagnosis of VL in areas of low VL endemicity.
将一种新型重组K39免疫层析试验（ICT）与免疫荧光抗体试验（IFA）进行比较，用于意大利南部普利亚地区内脏利什曼病（VL）的快速血清学诊断。共检测了264人，包括19例VL患者（其中3例为HIV阳性）、67例疑似VL患者、40例健康对照和138例其他疾病患者。ICT在所有19例VL患者中呈阳性，在其余个体的血清中呈阴性。ICT的敏感性和特异性均为100%。ICT在HIV-利什曼原虫合并感染患者中也表现良好。IFA和ICT检测到的利什曼原虫抗体在长达12 - 24个月内保持在可检测水平。ICT在高达1:20,480的血清稀释度下仍可检测到阳性反应，表明对重组K39抗原产生了强烈的免疫反应。总之，在VL低流行地区，ICT在VL诊断中具有高度敏感性、特异性、快速、无创且成本效益高（ICT为8.43欧元，IFA为12欧元）。
