内脏利什曼病快检试剂盒（胶体金法）

利什曼原虫（Leishmania spp）泛指利什曼虫属的锥体虫科原虫，是一种会引起利什曼病的寄生虫，在旧大陆的传播过程中是利用一种白蛉属的沙蝇为媒介，在新大陆的传播媒介则为沙蝇属(Lutzomyia)的沙蝇。利什曼原虫的主要宿主为脊椎动物，常见的感染对象包括蹄兔目、啮齿目、犬科、和人类。目前全世界有88个报告过利什曼原虫症的病例，感染人数达1200万人。在我国流行的是杜氏利什曼原虫（L. donovani），它能引起黑热病，又名黑热病原虫

【预期用途】

本试剂盒用于体外定性检测人血清盒全血样本中的黑热病（内脏利什曼原虫)病人特异性IgG抗体。内脏利什曼虫病或称黑热病，是由于内脏杜氏利什曼原虫团的利什曼原虫（杜氏利什曼原虫）或利什曼原虫寄生与人体巨噬细胞所引起的一种寄生病，由媒体白蛉叮咬传播。该病在世界内流行甚广，包括亚、欧、非、中、南美洲的60多个国家，每年新发生的病例数约有50万。

【检测原理】

本试剂盒采用胶体金免疫层析技术，检测人血清中的利什曼原虫特异IgG抗体。本试剂盒是用利什么曼原虫纯化抗原IgG抗体分别固相于硝酸纤维金标记得的链球菌G蛋白及其它的试剂制成。当今次那个是，金标记的链球菌G蛋白会与待血清的抗体结合形成复合物，若样本中存在利什曼原虫特异性抗体，该抗体与金标的链球菌G蛋白形成的复合物由于层析作用移动到检测线区域时，则该复合物被固有相与检测线区域内的利什曼原虫捕获而凝聚显色。若血样中没有利什么曼原虫特异抗体，则检测线不显色无论样本中是否存在利什曼原虫特异性抗体，一条色条带都会出现质控区，作为层析过程很正常，试剂是否失效的内控标准。

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Intended use

This kit is used for in vitro qualitative detection of patient specific IgG antibody of kala-azar (visceral leishmania protozoa) in human serum and whole blood samples.Visceral leishmaniasis, or kala-fever, is a parasitic disease caused by leishmaniasis (leishmaniasis duchenne) or leishmaniasis leishmaniasis parasitic and human macrophages, which is transmitted by the bite of sandflies.The disease is widespread in the world, including more than 60 countries in Asia, Europe, Africa, central and South America, with about 500,000 new cases each year.

[detection principle]

This kit USES colloidal gold immunochromatography to detect the leishmania protozoa-specific IgG antibody in human serum.This kit is made by using protozoa purified antigen IgG antibody to solid phase streptococcus G protein labeled by nitrate fiber gold and other reagents.Times today that is, gold tag streptococcus will G protein and serum antibody to form complexes, if the sample of specific antibodies, leishmania, the antibody with the gold mark streptococcus G protein to form compounds by chromatographic area move to the line, the lines of the compound is inherent facies zones of leishmania capture and color.If there is no leishmania specific antibody in the blood sample, the detection line will not color whether there is leishmania specific antibody in the sample or not, a color band will appear in the quality control area, which is the internal control standard for the normal chromatography process and whether the reagent fails.