Hosseini Farash Bibi Razieh, Mohebali Mehdi, Kazemi Bahram, Hajjaran Homa, Fata Abdolmajid, Raoofian Reza, Akhoundi Behnaz, Mojarrad Majid, Mastroeni Pietro, Sharifi-Yazdi Mohammad Kazem, Tanipour Mohammad Hossein
Department of Medical Parasitology and Mycology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
Department of Medical Parasitology and Mycology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
Iran J Parasitol. 2020 Jan-Mar;15(1):48-56.
Visceral leishmaniasis (VL) is the most severe form of leishmaniasis in Iran with high mortality rates in the case of inaccurate diagnosis and treatment. This study aimed to prepare and evaluate a new rk39 recombinant antigen from an Iranian strain of for diagnosis of VL in humans and dogs.
rK39-based enzyme-linked immunosorbent assay (ELISA) was compared with the direct agglutination test (DAT) for the detection of anti antibodies. We screened 84 human sera and 87 dog sera from clinical cases in the endemic area of Meshkin-Shahr, Iran along with 176 sera from healthy controls (collected from 86 humans and 90 dogs) during 2013-2016.
Using the rK39 ELISA, a sensitivity of 85.7% (95% CI, 95-99%) and a specificity of 86.0% (95% CI, 95%-99%) were detected in human sera at a 1:800 (cut-off) titer when DAT-confirmed cases were compared with healthy controls; a sensitivity of 96.6% (95% CI, 95%-99%) and specificity of 94.4% (95% CI, 95%-99%) were found at a 1:80 (cut-off) titer compared with DAT. Kappa analysis indicated agreement between the rK39 ELISA and DAT (0.718) when using human sera at a 1:800 (cut-off) titer as well as (0.910) at a 1:80 (cut-off) titer when using dog sera (<0.05).
New rk39 recombinant antigen from an Iranian strain of seems to be used for diagnosis of VL in humans and dogs. Further extended field studies are recommended.
内脏利什曼病（VL）是伊朗利什曼病最严重的形式，若诊断和治疗不准确，死亡率很高。本研究旨在制备并评估一种来自伊朗菌株的新型rk39重组抗原，用于诊断人和犬的VL。
将基于rK39的酶联免疫吸附测定（ELISA）与直接凝集试验（DAT）用于检测抗 抗体进行比较。在2013 - 2016年期间，我们从伊朗Meshkin - Shahr流行区的临床病例中筛选了84份人血清和87份犬血清，以及176份健康对照血清（分别来自86人及90只犬）。
使用rK39 ELISA，当将DAT确诊病例与健康对照进行比较时，在人血清中，效价为1:800（临界值）时检测到的灵敏度为85.7%（95% CI，95 - 99%），特异性为86.0%（95% CI，95% - 99%）；与DAT相比，在效价为1:80（临界值）时，灵敏度为96.6%（95% CI，95% - 99%），特异性为94.4%（95% CI，95% - 99%）。kappa分析表明，当使用人血清效价为1:800（临界值）时，rK39 ELISA与DAT之间的一致性为（0.718），当使用犬血清效价为1:80（临界值）时一致性为（0.910）（<0.05）。
来自伊朗菌株的新型rk39重组抗原似乎可用于诊断人和犬的VL。建议进一步开展扩大的现场研究。
