Abstract：
The diagnosis of tegumentary leishmaniasis (TL) is hampered by variable sensitivity and/or specificity of the tests. Serological assays are suitable to diagnose visceral leishmaniasis (VL); however, they present low performance for the detection of TL cases. Additionally, blood collection to obtain patient serum represents a challenge, as it is an invasive and uncomfortable procedure, requiring laboratorial infrastructure and trained professionals. In this context, the present study proposed to evaluate patient urine to detect TL, given that this analyte has proven to be effective in ELISA experiments for the detection of VL cases. For this, a Leishmania protein called LiHyV, two specific B-cell epitopes derived from protein amino acid sequence, and a Leishmania antigenic extract (SLA) were used as antigens. A total of 215 paired urine and serum samples were evaluated, and results showed that, when serum was employed as an analyte, rLiHyV, Peptide1, Peptide2, and SLA presented a sensitivity of 85 %, 29 %, 58 %, and 31 %, respectively, and a specificity of 97.5 %, 98 %, 100 %, and 97.5 %, respectively, in the diagnosis of TL. When urine was used, rLiHyV, Peptide1, Peptide2, and SLA presented a sensitivity of 95 %, 74 %, 67 %, and 52 %, respectively, and a specificity of 100 %, 99 %, 98 %, and 86 %, respectively. In conclusion, preliminary data suggest that urine could be considered as an alternative biological sample for the detection of TL cases.
摘要：
受累利什曼病（TL）的诊断受到测试灵敏度和/或特异性可变的阻碍。血清学测定适用于诊断内脏利什曼病（VL）；然而，它们在检测TL病例方面表现较低。此外,采集血液以获得患者血清是一个挑战，因为这是一种侵入性和不舒服的程序，需要实验室基础设施和训练有素的专业人员。在这种情况下，本研究提出评估患者尿液以检测TL，鉴于该分析物已被证明在用于检测VL病例的ELISA实验中是有效的。为此，一种叫做LiHyV的利什曼原虫蛋白,来自蛋白质氨基酸序列的两个特定B细胞表位，和利什曼原虫抗原提取物(SLA)用作抗原。共评估了215个配对的尿液和血清样本，结果表明，当血清被用作分析物时，rLiHyV,肽1、肽2和SLA的灵敏度为85%，29%,58%,31%,分别,特异性为97.5%，98%,100%,97.5%,分别,在TL的诊断中。当使用尿液时，rLiHyV,肽1、肽2和SLA的灵敏度为95%，74%,67%,52%,分别,和100%的特异性，99%,98%,86%,分别。总之,初步数据表明，尿液可被视为检测TL病例的替代生物样品。
