在MSM中应用性病自采样包进行生殖道沙眼衣原体感染核酸检测试剂的性能评估  

Performance evaluation of nucleic acid detection reagent for genital Cl hlamydia trachomatis using STD S g STD selfsampling package among MSM

作　　者：韩燕 肖东[3] 曹宁校 施美琴 陈凯[1,2] 王红春 徐文绮[1,2] 陈绍椿 尹跃平[1,2] 陈祥生 HAN Yan;XIAO Dong;CAO Ningxiao;SHI Meiqin;CHEN Kai;WANG Hongchun;XU Wenqi;CHEN Shaochun;YIN Yueping;CHEN Xiangsheng(Institute of Dermatology,Chinese Academy of Medical Sciences and Peking Union Medical College,Nanjing 210042,Jiangsu,China;National Center for Sexually Transmitted Diseases Control,Chinese Center for Disease Control and Prevention,Nanjing 210042,Jiangsu;Beijing Jingcheng Dermatology Hospital Beijing Youth Health Center,Bejing 100101)

机构地区：[1]中国医学科学院北京协和医学院皮肤病医院(中国医学科学院北京协和医学院皮肤病研究所),南京210042 [2]中国疾病预防控制中心性病控制中心,南京210042 [3]北京京城皮肤病医院北京青年健康中心,北京100101

出　　处：《中国艾滋病性病》2023年第5期579-582,共4页Chinese Journal of Aids & STD

基　　金：中国医学科学院医学与健康科技创新工程项目(2021-I2M-C&T-B-086);中国公共卫生联盟课题(GWLM202004)。

摘　　要：目的 评价在MSM中应用性病自采样包仁度尿液保存管自采集尿液进行生殖道沙眼衣原体核酸检测的性能。方法 自制自采样包,线上通过“爱易检”平台,线下通过社区组织招募MSM,分发自采样包,MSM领取自采样包完成自采尿液分装至仁度和罗氏保存管后送检至指定实验室同时进行生殖道沙眼衣原体核酸检测,以罗氏核酸检测结果为金标准,评估仁度核酸检测试剂的性能。结果 发放845份自检测和自采样包,完成送检767份,763份标本同时完成了仁度和罗氏检测,阳性率分别为6.29%(48/763)、6.82%(52/763)。以罗氏为参比试剂,仁度试剂检测生殖道沙眼衣原体的灵敏度为76.92%(40/52),特异性为98.87%(703/711)。两种试剂在利用尿液进行生殖道沙眼衣原体检测的差异无统计学意义(McNemarχ^(2)=0.45,P>0.05)。结论 在MSM中应用自采样包进行生殖道沙眼衣原体检测接受高,仁度试剂检测性能较好,经进一步优化后今后可应用在性病自采样包中。Objective To evaluate the performance of nucleic acid detection reagent for genital Chlamydia trachomatis using sexually transmitted infections(STD)self-sampling package and Rendu urine preservation tube among men who have sex with men(MSM).Methods The self-made STD self-sampling packages were distributed to MSM recruited from"Aiyijian"platform online and community organizations on-site.Urine samples were self-collected and subpackaged with Rendu and Roche preservation tubes,then submitted to the designated laboratory to detect the nucleic acid of Chlamydia trachomatis.The results of Roche nucleic acid detection were used as the gold standard to evaluate the performance of Rendu nucleic acid detection reagents.Results Totally 845 self-sampling packages were distributed,with 767 samples submitted to laboratory.Totally 763 samples had finished Rendu and Roche tests simultaneously,and the positive rates were 6.29%(48/763)and 6.82%(52/763),respectively.Using Roche as the reference reagent,the sensitivity and specificity of Rendu assay for genital Chlamydia trachomatis were 76.92%(40/52)and 98.87%(703/711),respectively.There was no statistically significant difference in the detection for genital Chlamydia trachomatis between the two assays(McNemar X^(2)=0.45,P>0.05).Conclusions Self-sampling packages for detecting of genital Chlamydia trachomatis is highly acceptable among MSM.Rendu assay has high specificity for urine detecting,and can be introduced to self-sampling packages for diagnosing STD by further optimization.

关 键 词：尿液 沙眼衣原体 自采样包 男男性行为者 

分 类 号：R374.1[医药卫生—病原生物学]