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囊虫IgG胶体金诊断试剂盒(层析法)的研制和考核 被引量:5

DEVELOPMENT AND CLINICAL TRAIL OF DIAGNOSTIC KIT(COLLOID GOLD) FOR IgG ANTIBODY TO CYSTICERCOSIS
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摘要 目的 在国内外率先开发成功用于囊虫病诊断的IgG金标层析法 (一步法 )诊断试剂盒。方法 采用独特制备猪囊尾蚴囊液抗原的方法 ;先进制备胶金试剂盒工艺并以比利时提供的囊虫IgG试剂盒 (ELISA)做参照。 结果 产品经中国药品生物制品检定所检定合格。对试剂盒的特异性、敏感性进行了临床考核。其敏感性为 93 .2 3 % ,特异性为 97.3 7% ,该试剂盒检测包虫血清的交叉反应率为 4 5 .0 0 % ,与血吸虫、肝吸虫、肺吸虫等寄生虫病人血清无交叉反应。结论 该试剂盒敏感性、特异性良好 ,操作简单、快速 ,结果判读容易 ,特别适用于基层和现场应用。 A chromatographic immunoassay device (one step method) for IgG antibody against cysticercosis was developed. The kit was tested and certified by National Institute for The Control of Pharmaceutical and Biological Products of China. Sensitivity and specificity of the kit were 93.23% and 97.37% respectively, and Joden index was 0.91 according to a clinical trail in 264 samples. 45% of cross reactive rate was found in 20 samples with echinococcosis, and no cross reaction was found in other samples infected with helminths. This method is very simple and rapid for performing and reading, as well as useful to apply in the field and rural area.
出处 《中国人兽共患病杂志》 CSCD 北大核心 2001年第6期59-61,共3页 Chinese Journal of Zoonoses
关键词 囊虫病 诊断试剂盒 胶体金 层析法 Cysticercosis Diagnostic kit Colloid gold Chromatographic immunoassay
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