Laboratório de Pesquisas Clínicas, Centro de Pesquisas René Rachou, Fundação Oswaldo Cruz, Belo Horizonte, Minas Gerais, Brazil.
Trans R Soc Trop Med Hyg. 2011 Feb;105(2):81-5. doi: 10.1016/j.trstmh.2010.09.004. Epub 2010 Oct 20.
The diagnosis of visceral leishmaniasis (VL) is still a major problem in Brazil and several other countries where the disease is endemic. The use of an easy-to-use and interpret, sensitive, and specific method that requires no complex infrastructure or specialized professionals, such as direct agglutination test (DAT) and the rK39-based rapid immunochromatographic test may enhance the diagnosis of disease. This study evaluated the performance of a rapid test (DiaMed- IT-LEISH®) and the DAT for the diagnosis of VL in 213 parasitologically confirmed cases and 119 controls with clinical suspicion of VL and confirmation of another etiology. The sensitivities and specificities of the rapid test were 93% and 97%, respectively and those of the DAT were 90% and 96%, respectively. The positive predictive values of the rapid test and the DAT were 98% and 97%, respectively and the negative predictive values were 89% and 84%, respectively. The Kappa index showed agreement between both methods classified as substantial (0.77). This study showed that the DAT and the rapid test can be used to diagnose VL in Brazil, following a pilot study for implementation of the rapid test in the health services.
内脏利什曼病（VL）的诊断在巴西和其他几个该病流行的国家仍然是一个主要问题。使用易于使用和解释、敏感和特异的方法，而不需要复杂的基础设施或专业人员，例如直接凝集试验（DAT）和基于 rK39 的快速免疫层析试验，可以提高疾病的诊断。本研究评估了一种快速检测方法（DiaMed-IT-LEISH®）和 DAT 在 213 例寄生虫学确诊病例和 119 例临床疑似 VL 并证实为其他病因的对照中的表现。快速检测的敏感性和特异性分别为 93%和 97%，DAT 的敏感性和特异性分别为 90%和 96%。快速检测和 DAT 的阳性预测值分别为 98%和 97%，阴性预测值分别为 89%和 84%。Kappa 指数显示两种方法之间的一致性为中等（0.77）。本研究表明，DAT 和快速检测可用于巴西的 VL 诊断，随后进行了快速检测在卫生服务中的实施试点研究。
