国产核酸检测试剂检测生殖道多部位标本中的生殖道沙眼衣原体的性能评估  

Evaluation of a domestic nucleic acid detection reagent for Chlamydia trachomatis in reproductive tract specimens

作　　者：施美琴 韩燕[1] 陈凯 周可 陈忆[4] 胡丽华[5] 尹跃平[1,2] SHI Meiqin;HAN Yan;CHEN Kai;ZHOU Ke;CHEN Yi;HU Lihua;YIN Yueping(Hospital for Skin Diseases,Institute of Dermatology,Chinese Academy of Medical Sciences&Peking Union Medical College,Nanjing 210042,Jiangsu,China;Chinese Center for Disease Control and Prevention,Nanjing 210042,Jiangsu,China;Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital,Tianjin 300120,China;International Peace Maternity&Child Health Hospital of China Welfare Institute,Shanghai 200030,China;Institute of Dermatology Prevention and Treatment of Zhejiang Province,Huzhou 313200,Zhejiang,China)

机构地区：[1]中国医学科学院皮肤病医院(中国医学科学院皮肤病研究所),南京210042 [2]中国疾病预防控制中心性病控制中心,南京210042 [3]天津中医药研究院附属医院,天津300120 [4]中国福利会国际和平妇幼保健院,上海200030 [5]浙江省皮肤病防治研究所,浙江湖州313200

出　　处：《中国艾滋病性病》2024年第6期623-627,共5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)。

摘　　要：目的 探讨国产核酸检测试剂检测生殖道多部位标本中的生殖道沙眼衣原体的性能。方法 在三个医院招募患者,采集男性患者尿液、尿道拭子和女性患者的尿液、阴道拭子及宫颈拭子等生殖道部位的标本,以罗氏Cobas 4800CT/NG为参评试剂,探讨国产DNA检测试剂检测生殖道沙眼衣原体的性能。结果 共招募457名患者,其中248名女性患者。共采集456份尿液标本、205份男性尿道拭子,248份阴道拭子和248份宫颈拭子标本。该国产核酸检测试剂尿液检测生殖道沙眼衣原体灵敏度为61.8%(95%CI:43.6%~77.3%),特异性为95.0%(95%CI:92.4%~96.8%);宫颈拭子检测灵敏度为80.0%(95%CI:51.4%~94.7%),特异性为98.7%(95%CI:96.0%~99.7%);阴道拭子检测灵敏度为80.0%(95%CI:51.4%~94.7%),特异性为99.1%(95%CI:96.6%~99.9%);男性尿道拭子检测生殖道沙眼衣原体灵敏度为50.0%(95%CI:26.9%~73.2%),特异性为84.0%(95%CI:77.7%~88.8%)。结论 该国产核酸检测试剂利用宫颈拭子和阴道拭子进行生殖道沙眼衣原体检测的灵敏度和特异性较好,但是利用尿液和男性尿道拭子进行检测的灵敏度较低,推测可能与样本保存方法不当、核酸提取效率不高、使用不合适的采样拭子、采集到患者的有效样本量不足等有关。Objective The study evaluated the performance of a domestic nucleic acid detection reagent for detecting Chlamydia trachomatis in reproductive tract specimens.Methods Patients were recruited from three hospitals.Reproductive tract specimens were collected,including urine samples and urethral swabs from male patients,as well as urine samples,vaginal swabs,and cervical swabs from female patients.The Cobas 4800CT/NG system(Roche)was used as a reference to assess the performance of the domestic DNA detection reagent.Results A total of 457 patients were enrolled,with 248 being female.The following number of specimens were collected:456 urine samples,205 male urethral swabs,248 vaginal swabs,and 248 cervical swabs.The sensitivity and specificity of the domestic reagent were lower when using urine samples(sensitivity=61.8%,95%CI:43.6%-77.3%;specificity=95.0%,95%CI:92.4%-96.8%).The domestic reagent demonstrated good performance for detecting C.trachomatis in cervical swabs(sensitivity=80.0%,95%CI:51.4%-94.7%;specificity=98.7%,95%CI:96.0%-99.7%),vaginal swabs(sensitivity=80.0%,95%CI:51.4%-94.7%;specificity=99.1%,95%CI:96.6%-99.9%),and poor performance in male urethral swabs(sensitivity=50.0%,95%CI:26.9%-73.2%;specificity=84.0%,95%CI:77.7%-88.8%).Conclusions This study suggests that the domestic reagent has good sensitivity and specificity for detecting C.trachomatis in the female reproductive tract using cervical swabs and vaginal swabs.However,sensitivity is lower when using urine and male urethral swabs.This may be due to factors such as improper specimen storage,low nucleic acid extraction efficiency,unsuitable swabs,or an insufficient number of samples used in the analysis.

关 键 词：衣原体 沙眼 核酸检测试剂 生殖道 

分 类 号：R374[医药卫生—病原生物学]