Teixeira Ana Izabel Passarella, Silva Debora Marcolino, Vital Tamires, Nitz Nadjar, de Carvalho Bruna Caroline, Hecht Mariana, Oliveira Diana, Oliveira Edward, Rabello Ana, Romero Gustavo Adolfo Sierra
Universidade de Brasília, Núcleo de Medicina Tropical, Brasília, DF, Brasil.
Universidade de Brasília, Faculdade de Medicina, Laboratório Interdisciplinar de Biociências, Brasília, DF, Brasil.
Mem Inst Oswaldo Cruz. 2019 Jan 31;114:e180452. doi: 10.1590/0074-02760180452.
Studies aimed at validating canine visceral leishmaniasis diagnostic tests present heterogeneous results regarding test accuracy, partly due to divergences in reference standards used and different infection evolution periods in animals.
This study aimed to evaluate the accuracy of the rapid test-dual path platform (TR-DPP) (Biomanguinhos®), EIE-Leishmaniose-Visceral-Canina-Biomanguinhos (EIE-LVC) (Biomanguinhos®), enzyme-linked immunosorbent assay (ELISA) rK39 (in-house), and the direct agglutination test (DAT-Canis) against a reference standard comprising parasitological and molecular techniques.
A phase II/III validation study was carried out in sample sera from 123 predominantly asymptomatic dogs living in an area endemic for visceral leishmaniasis.
Sixty-nine (56.1%) animals were considered infected according to the reference standard. For each test, the sensitivity and specificity, respectively, were as follows: TR-DPP, 21.74% [confidence interval (CI)95% 13.64% to 32.82%] and 92.59% (CI95% 82.45% to 97.08%); EIE-LVC, 11.59% (CI95% 5.9% to 21.25%) and 90.74% (CI95% 80.09% to 95.98%); ELISA rK39, 37.68% (CI95% 27.18% to 49.48%) and 83.33% (CI95% 71.26% to 90.98%); and DAT-Canis, 18.84% (CI95% 11.35% to 29.61%) and 96.30% (CI95% 87.46% to 98.98%).
We concluded that improving the sensitivity of serum testing for diagnosing asymptomatic dogs must constitute a priority in the process of developing new diagnostic tests to be used in the visceral leishmaniasis control program in Brazil.
旨在验证犬内脏利什曼病诊断检测方法的研究在检测准确性方面呈现出异质性结果，部分原因是所使用的参考标准存在差异以及动物感染的不同演变阶段。
本研究旨在评估快速检测双路径平台（TR-DPP）（BioManguinhos®）、EIE-内脏利什曼病-犬用-BioManguinhos（EIE-LVC）（BioManguinhos®）、酶联免疫吸附测定（ELISA）rK39（自制）和直接凝集试验（DAT-Canis）相对于包含寄生虫学和分子技术的参考标准的准确性。
在来自生活在内脏利什曼病流行地区的123只主要无症状犬的样本血清中进行了一项II/III期验证研究。
根据参考标准，69只（56.1%）动物被认为感染。每种检测的敏感性和特异性分别如下：TR-DPP，21.74%[95%置信区间（CI）13.64%至32.82%]和92.59%（CI95% 82.45%至97.08%）；EIE-LVC，11.59%（CI95% 5.9%至21.25%）和90.74%（CI95% 80.09%至95.98%）；ELISA rK39，37.68%（CI95% 27.18%至49.48%）和83.33%（CI95% 71.26%至90.98%）；以及DAT-Canis，18.84%（CI95% 11.35%至29.61%）和96.30%（CI95% 87.46%至98.98%）。
我们得出结论，在巴西内脏利什曼病控制项目中开发新的诊断检测方法的过程中，提高无症状犬血清检测的敏感性必须成为优先事项。
