Mahachi Kurayi G, Ozanne Marie, Bourdeau Patrick, Sarquis Juliana, Kontowicz Eric, Solano-Gallego Laia, Cardoso Luis, Oliva Gaetano, Baneth Gad, Pennisi Maria Grazia, Toepp Angela M, Miró Guadalupe, Carrel Margaret, Petersen Christine A
College of Public Health, University of Iowa, Iowa City, IA, USA.
Department of Mathematics and Statistics, Mount Holyoke College, South Hadley, MA, USA.
Parasit Vectors. 2024 Dec 29;17(1):545. doi: 10.1186/s13071-024-06631-9.
Visceral leishmaniosis (VL) is the most severe form of human leishmaniosis, with an estimated 95% case fatality if left untreated. Dogs act as peridomestic reservoir hosts for the protozoan parasite Leishmania infantum, a causative agent for human leishmaniosis, endemic throughout the Mediterranean basin. To assure consistent and accurate surveillance of canine infection and prevent transmission to people, consistent diagnosis of canine L. infantum infection across this region is essential for protecting both human and animal health. Our goal was to compare the accuracy, sensitivity and specificity of enzyme-linked immunosorbent assays (ELISA) and immunofluorescence antibody tests (IFAT), performed at seven academic veterinary diagnostic centres across southern Europe and Israel.
We performed a known sample "ring" trial to compare L. infantum quantitative serological tests. Two hundred seventy-two (n = 272) canine serum samples of known serological status were chosen from these sites, representative of the region. In-house or commercial ELISA and IFAT were performed according to each laboratory's specifications. Latent Class Analysis (LCA) was used to determine sensitivity and specificity of each test. True and false positives were calculated to determine the probability of identifying samples.
Sensitivity and specificity for ELISA ranged from 95 to 99% and 92% to 97%, respectively, with moderate variability from one site. Sensitivity and specificity for IFAT ranged from 89 to 99% and 83% to 94%, respectively, with increased variability compared to ELISA. Overall test agreement was 78% with a pair-wise agreement between 65 and 89%.
All sites demonstrated substantial comparative diagnostic accuracy, with good agreement based on known seropositive and seronegative samples. Studies and interventional trials that use these tests will remain valid because of high diagnostic agreement between sites.
内脏利什曼病（VL）是人类利什曼病最严重的形式，若不治疗，估计病死率达95%。犬作为原生动物寄生虫婴儿利什曼原虫的家养宿主，该寄生虫是人类利什曼病的病原体，在地中海盆地各地流行。为确保对犬感染情况进行持续且准确的监测，并防止传播给人类，在该地区对犬婴儿利什曼原虫感染进行一致的诊断对于保护人类和动物健康至关重要。我们的目标是比较在南欧和以色列的七个学术兽医诊断中心进行的酶联免疫吸附测定（ELISA）和免疫荧光抗体试验（IFAT）的准确性、敏感性和特异性。
我们进行了一项已知样本“环”试验，以比较婴儿利什曼原虫定量血清学检测。从这些地点选取了272份已知血清学状态的犬血清样本，代表该地区。根据每个实验室的规范进行内部或商业ELISA和IFAT检测。使用潜在类别分析（LCA）来确定每项检测的敏感性和特异性。计算真阳性和假阳性以确定识别样本的概率。
ELISA的敏感性和特异性分别为95%至99%和92%至97%，各地点之间存在适度差异。IFAT的敏感性和特异性分别为89%至99%和83%至94%，与ELISA相比差异更大。总体检测一致性为78%，两两一致性在65%至89%之间。
所有地点均显示出较高的比较诊断准确性，基于已知的血清阳性和血清阴性样本有良好的一致性。由于各地点之间诊断一致性高，使用这些检测的研究和干预试验仍然有效。
