免疫荧光法检测奈瑟氏淋球菌方法的建立及其临床应用评价  

Establishment and Clinical Performance Evaluation of Neisseria Gonorrhoeae Immunofluorescence Detection Kit

作　　者：唐盛[1] 林恒先 龚海涛[2] 单万水[3] 

机构地区：[1]深圳大学医学院,广东深圳518060 [2]深圳市迈科龙生物技术有限公司,广东深圳518057 [3]深圳市第三人民医院检验科,广东深圳518020

出　　处：《标记免疫分析与临床》2011年第2期107-111,共5页Labeled Immunoassays and Clinical Medicine

摘　　要：通过试验研究,确定了抗体荧光标记的最佳条件、免疫荧光法检测的最适抗体浓度及最佳反应条件,从而研究免疫荧光法检测奈瑟氏淋球菌方法的建立,并对奈瑟氏淋球菌免疫荧光法检测试剂盒进行临床试验,评价其检测效果。采用分离培养法和奈瑟氏淋球菌免疫荧光法检测试剂盒对1100例临床样本进行平行检测,并以分离培养法检测结果为对照,统计免疫荧光试剂盒与分离培养法检测结果的总符合率及阴、阳性符合率。试验结果统计分析显示,受测免疫荧光试剂盒检测与分离培养法检测的总符合率为97.64%,阳性符合率为93.28%,阴性符合率为98.17%,Kappa值>0.8,表明受测免疫荧光试剂盒与分离培养法的临床检测结果无显著性差异。受测免疫荧光法检测试剂盒检测快速、简便、经济、准确,可用于奈瑟氏淋球菌的临床快速诊断。The best reaction condition of the labeling processing and the best concentration of the antibody were researched for the Neisseria gonorrhoeae（NG） immunofluorescence reagent.To test the Neisseria gonorrhoeae detection kit（Immunofluorescence） through clinical trials and evaluate its application value,a parallel-controlled method was carried out,and the clinical samples were both tested with the Neisseria gonorrhoeae immunofluorescence detection kit and isolated culture,which was used as contrast.Total 1100 samples were tested,and the overall coincidence rate was 97.64%.The positive coincidence rate was 93.28%,and the negative coincidence rate was 98.17%,and the Kappa value surpassed 0.8,which indicated that there was no significant difference between the test results of the immunofluorescence detection kit and of isolated culture.The Neisseria gonorrhoeae immunofluorescence detection kit of Microprofit owns the potential of providing a rapid,simple,economical and accurate clinical detection means for Neisseria gonorrhoeae.

关 键 词：奈瑟氏淋球菌 分离培养法 免疫荧光法 单克隆抗体 

分 类 号：R446.6[医药卫生—诊断学]