巴西用于诊断犬内脏利什曼病的 rK39 ELISA 原型的 II 期验证研究。
Phase II validation study of the rK39 ELISA prototype for the diagnosis of canine visceral leishmaniasis in Brazil.
机构信息
Fundação Ezequiel Dias, Belo Horizonte, Brasil.
Ministério da Saúde, Brasília, Brasil.
出版信息
Cad Saude Publica. 2021 Apr 7;37(3):e00041320. doi: 10.1590/0102-311X00041320. eCollection 2021.
Dogs are the main reservoirs in the domestic transmission cycle of visceral leishmaniasis, and the diagnosis is essential for the effectiveness of the control measures recommended by the Brazilian Ministry of Health. We assessed the diagnostic performance of the ELISA-Vetlisa/BIOCLIN prototype with serum samples from 200 dogs, in triplicate, including symptomatic, oligosymptomatic, asymptomatic, and healthy dogs, originated by two distinct panels (A and B) characterized by parasitological tests as the reference standard. In this study, the prototype kit showed a 99% sensitivity (95%CI: 94.5-100.0) and a 100% specificity (95%CI: 96.4-100.0). The sensitivity of the prototype kit did not vary significantly with the clinical status of the dogs. Considering the final result classification (positive or negative), agreement between the results of repeated tests was almost perfect (kappa = 0.99; 95%CI: 0.98-1.00). ELISA-Vetlisa/BIOCLIN is a promising option for the serological diagnosis of canine visceral leishmaniasis in Brazil.
狗是内脏利什曼病在国内传播周期中的主要宿主，诊断对于巴西卫生部推荐的控制措施的有效性至关重要。我们评估了 ELISA-Vetlisa/BIOCLIN 原型试剂盒用 200 只犬的血清样本进行三重检测的诊断性能，包括有症状、少症状、无症状和健康犬，这些犬来自两个不同的小组（A 和 B），寄生虫学检测为参考标准。在这项研究中，原型试剂盒的敏感性为 99%（95%CI：94.5-100.0），特异性为 100%（95%CI：96.4-100.0）。原型试剂盒的敏感性与犬的临床状况没有显著差异。考虑到最终结果分类（阳性或阴性），重复测试的结果之间几乎完全一致（kappa = 0.99；95%CI：0.98-1.00）。ELISA-Vetlisa/BIOCLIN 是巴西犬内脏利什曼病血清学诊断的一个有前途的选择。
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