BACKGROUND Kinesin-related gene diversity among strains and species of Leishmania may impact the sensitivity and specificity of serodiagnostic tests for visceral leishmaniasis (VL). METHODS In this study, we report on the recombinant expression of this novel Iranian Leishmania infantum (MCAN14/47) homologue of rK39 (Li-rK39), in L. tarentolae. The diagnostic potential of the Li-rK39 antigen was evaluated in an ELISA, using sera from 100 VL patients, 190 healthy endemic controls, 46 non-endemic healthy controls and 47 patients with other infections. RESULTS The results showed a sensitivity of 96% and a specificity of 93.8%. A commercial rK39 immunochromatographic test (ICT) was 90% sensitive and 100% specific on the same cohort. CONCLUSIONS Here, we show that the K39 gene from an Iranian L. infantum isolate is heterozygous as compared to the sequence of the Brazilian L. infantum (former L. chagasi), whose antigen is incorporated in most rK39-based immunochromatographic tests. Therefore, Li-rK39 has the potential to be used as an alternative for VL diagnosis in Iran.

中文翻译：

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来自伊朗利什曼原虫分离株的rK39同源物在塔氏利什曼原虫中的表达，用于内脏利什曼病的血清学诊断。

背景技术利什曼原虫的菌株和物种之间与动蛋白相关的基因多样性可能影响内脏利什曼病（VL）的血清学诊断测试的敏感性和特异性。方法在本研究中，我们报道了在塔伦托雷氏菌中，rK39（Li-rK39）的这一新的伊朗婴儿利什曼原虫（MCAN14 / 47）同源物的重组表达。使用来自100 VL患者，190例健康地方病对照，46例非地方病健康对照和47例其他感染患者的血清，在ELISA中评估了Li-rK39抗原的诊断潜力。结果结果显示灵敏度为96％，特异性为93.8％。商业rK39免疫色谱测试（ICT）在同一队列中具有90％的敏感性和100％的特异性。结论在这里，我们显示了来自伊朗L.的K39基因。与巴西婴儿乳杆菌（前南美乳杆菌）的序列相比，婴儿分离株是杂合的，后者的抗原已整合到大多数基于rK39的免疫色谱测试中。因此，Li-rK39有潜力用作伊朗VL诊断的替代方法。