Duarte Mariana Costa, Ferraz Isabela de Andrade, Carvalho Ana Maria Ravena Severino, Mendes Tiago Antônio de Oliveira, Medeiros Fernanda Alvarenga Cardoso, Eleutério Níbia Mariana, Costa-Silva Matheus Fernandes, Coelho Eduardo Antonio Ferraz, Rocha Manoel Otávio da Costa, Menezes-Souza Daniel
Programa de Pós-Graduação em Ciências da Saúde: Infectologia e Medicina Tropical, Faculdade de Medicina, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil; Departamento de Patologia Clínica, COLTEC, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.
Programa de Pós-Graduação em Ciências da Saúde: Infectologia e Medicina Tropical, Faculdade de Medicina, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.
Diagn Microbiol Infect Dis. 2025 Oct;113(2):116948. doi: 10.1016/j.diagmicrobio.2025.116948. Epub 2025 Jun 11.
Endemic to Brazil, Human Visceral Leishmaniasis (HVL), caused by Leishmania infantum and vectored by sand flies, is characterized by a complex and often overlapping set of symptoms, including prolonged fever, weight loss, organomegaly, anaemia, and bleeding. The diagnostic process for HVL is frequently hindered by the disease's nonspecific clinical presentation and the inherent limitations of existing serological assays, which often exhibit suboptimal sensitivity and specificity, predisposing to diagnostic inaccuracies. Developing of sensitive and specific diagnostic assays is crucial for effective HVL control in Brazil, enabling early disease detection and improving treatment outcomes. To enhance diagnostic capabilities, we evaluated the performance of a chimeric protein designed from B-lymphocyte cell epitopes identified through immunoproteomic analysis in serological tests for detecting L. infantum infection. Under the experimental conditions, the chimeric protein demonstrated the following diagnostic performance: 100 % specificity against control samples, 94.12 % specificity against Chagas disease samples, and 100 % sensitivity for HVL-positive individuals. Receiver Operating Characteristic (ROC) curve analysis demonstrated the following performance metrics: area under the curve (AUC) of 0.9960, 100 % sensitivity, and 97.10 % overall specificity, significantly exceeding the performance of the L. infantum soluble antigen (SLiA) ELISA. These findings suggest that the chimeric protein represents a promising antigen for developing of improved HVL diagnostic technologies, potentially reducing the disease's public health impact.
人类内脏利什曼病（HVL） endemic于巴西，由婴儿利什曼原虫引起，白蛉为其传播媒介，其特征是一系列复杂且常常相互重叠的症状，包括长期发热、体重减轻、器官肿大、贫血和出血。HVL的诊断过程常常受到该疾病非特异性临床表现以及现有血清学检测方法固有局限性的阻碍，这些检测方法往往灵敏度和特异性欠佳，容易导致诊断不准确。开发灵敏且特异的诊断检测方法对于巴西有效控制HVL至关重要，能够实现疾病的早期检测并改善治疗效果。为提高诊断能力，我们评估了一种嵌合蛋白的性能，该蛋白由通过免疫蛋白质组分析鉴定出的B淋巴细胞细胞表位设计而成，用于检测婴儿利什曼原虫感染的血清学检测。在实验条件下，该嵌合蛋白表现出以下诊断性能：对对照样本的特异性为100%，对恰加斯病样本的特异性为94.12%，对HVL阳性个体的灵敏度为100%。受试者操作特征（ROC）曲线分析显示出以下性能指标：曲线下面积（AUC）为0.9960，灵敏度为100%，总体特异性为97.10%，显著超过婴儿利什曼原虫可溶性抗原（SLiA）ELISA的性能。这些发现表明，该嵌合蛋白是开发改进的HVL诊断技术的一种有前景的抗原，有可能降低该疾病对公共卫生的影响。
