荧光标记MOMP抗体检测沙眼衣原体的方法及性能评价  

The Detection of Chlamydia Trachomatis by Fluorescein Isothiocyanate Labeled MOMP Antibody and Its Performance Evaluation

作　　者：刘小平[1] 樊尚荣[2] 陈晓明 黄荣 闫津津[1] LIU Xiao-ping;FAN Shang-rong;CHEN Xiao-ming;HANG Rong;YAN Jin-jin(Department of Medical Laboratory Sciences,Peking University Shenzhen Hospital,Shenzhen 518036,China;Department of Gynaecology and Obstetrics,Peking University Shenzhen Hospital,Shenzhen 518036,China;Shenzhen Microprofit Biotech Co.,Ltd,Shenzhen 518057,China;Department of Medical Laboratory Sciences,Shenzhen Hospital of South University Shenzhen,China 518110)

机构地区：[1]北京大学深圳医院检验科,广东深圳518036 [2]北京大学深圳医院妇产科,广东深圳518036 [3]深圳迈克龙生物技术有限公司,广东深圳518057 [4]南方大学深圳医院检验科,广东深圳518110

出　　处：《标记免疫分析与临床》2019年第5期858-862,共5页Labeled Immunoassays and Clinical Medicine

基　　金：深圳市卫生系统科研项目(编号:201501026)

摘　　要：目的建立异硫氰酸荧光素标记沙眼衣原体主要外膜蛋白单克隆抗体直接免疫荧光法检测沙眼衣原体的方法,并评价其灵敏度和特异性。方法双盲法。采集女性宫颈拭子双份,一份免疫荧光法检测,另一份采用荧光定量PCR检测。以PCR测定结果作为标准,分别计算DFA和PCR结果的一致性。结果共检测142份宫颈拭子,准确率为99.3%,其中阳性符合率为90.9%,阴性符合率为100%。Kappa系数一致性检验,k为0.894。荧光标记MOMP抗体检测沙眼衣原体灵敏度、特异性与PCR两种方法检测结果一致。结论异硫氰酸标记沙眼衣原体主要外膜蛋白单克隆抗体法检测沙眼衣原体有较高的灵敏度和特异性,可用于临床检验。Objective Chlamydia trachomatis is considered as the most common causing factor of sexually transmitted diseases.A test method of fluorescein isothiocyanate(FITC)labeled major outer membrane protein(MOMP)assay for the detection of Chlamydia trachomatis antigen was established in this study.The sensitivity and specificity of the test were also evaluated.Methods The double endocervical swabs from female patients were collected following the standard procedures.One sample was detected for Chlamydia trachomatis by using PCR through the amplification of a specific sequence and the other sample was detected for Chlamydia trachomatis by using FITC labeled MOMP assay.The double blind method was used to test the consistence.Results Out of 142 samples tested,the correct rate of FITC labeled MOMP assay was 99.3%.The sensitivity and specificity of the assay was 90.9% and 100%,respectively.Kappa value was 0.894.Conclusion FITC labeled MOMP assay for the detection of Chlamydia trachomatis has a high sensitivity and specificity and could be used in the clinical detection of Chlamydia trachomatis.

关 键 词：沙眼衣原体 主要外膜蛋白单克隆抗体 异硫氰酸荧光素 

分 类 号：R446.5[医药卫生—诊断学]