Freire Mariana Lourenço, de Avelar Daniel Moreira, Pedras Mariana Junqueira, Alves Líndicy Leidicy, de Faria Veronica Cardoso Santos, Saraiva Lara, Machado de Assis Tália Santana, Costa Dorcas Lamounier, Cota Gláucia
Pesquisa Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias, Instituto René Rachou - Fundação Oswaldo Cruz, Belo Horizonte, Brasil.
Centro Federal de Educação Tecnológica de Minas Gerais, Contagem, Brasil.
PLoS Negl Trop Dis. 2025 Jun 2;19(6):e0013087. doi: 10.1371/journal.pntd.0013087. eCollection 2025 Jun.
Visceral leishmaniasis (VL) represents a significant public health concern due to its high case-fatality, which poses the challenge of a timely and accurate diagnosis. Antibody-based rapid diagnostic tests (RDTs) have emerged as a disruptive innovation in recent years, by offering a diagnosis in the field, at low cost, easy to perform and with results in a few minutes. However, their performance can vary across regions and different subgroups, particularly in immunocompromised individuals. This study aimed to assess the accuracy of VL RDTs registered with the Brazilian national regulatory agency, or available through the PAHO strategic fund, considering diverse patient profiles.
METHODOLOGY/PRINCIPAL FINDINGS: Three commercially RDTs were identified LSH Ab Eco Teste, Leishmaniasis VH Bio, and Kalazar Detect and evaluated using a well characterized panel of serum samples (n = 300) from suspected VL patients from different Brazilian regions. Sensitivity, specificity, and accuracy were determined for different patient's ages and HIV coinfection status. Overall, RDTs exhibited lower sensitivity in children under 3 years old and HIV co-infected individuals compared to those over 3 years without HIV co-infection (p < 0.05). The agreement (Cohen's kappa coefficient) between observers (reproducibility) and intra-test (repeatability) for all three commercial kits was excellent.
CONCLUSIONS/SIGNIFICANCE: While RDTs offer desirable advantages in terms of access to diagnoses, variation on their performance imposes limits on their implementation. The performance of RDTs for VL exhibits significant differences related to age and immune status.
内脏利什曼病（VL）因其高病死率而成为重大的公共卫生问题，这给及时准确的诊断带来了挑战。近年来，基于抗体的快速诊断检测（RDTs）作为一种突破性创新出现，它能够在现场进行诊断，成本低，操作简便，几分钟内即可得出结果。然而，其性能在不同地区和不同亚组中可能会有所不同，尤其是在免疫功能低下的个体中。本研究旨在评估在巴西国家监管机构注册或通过泛美卫生组织战略基金获得的VL RDTs的准确性，同时考虑不同的患者特征。
方法/主要发现：确定了三种商业RDTs，即LSH Ab Eco Teste、利什曼病VH Bio和黑热病检测试剂盒，并使用来自巴西不同地区疑似VL患者的一组特征明确的血清样本（n = 300）进行评估。确定了不同患者年龄和HIV合并感染状态下的敏感性、特异性和准确性。总体而言，与3岁以上未合并HIV感染的个体相比，RDTs在3岁以下儿童和HIV合并感染个体中的敏感性较低（p < 0.05）。所有三种商业试剂盒在观察者之间的一致性（科恩kappa系数）（再现性）和试验内（重复性）均非常好。
结论/意义：虽然RDTs在诊断可及性方面具有理想的优势，但其性能差异限制了它们的应用。VL的RDTs性能在年龄和免疫状态方面存在显著差异。
