不同科室来源沙眼衣原体宫颈拭子样本的检测分析

Evaluation of two methodologies for Chlamydia trachomatis detection in cervical samples of two clinics

目的通过与实时荧光PCR检测结果进行比较，分析两种沙眼衣原体检测方法检测两个科室来源的宫颈拭子样本效果，为临床应用提供参考。方法采集河南省人民医院妇科门诊2014年5月至2015年5月期间，怀疑感染沙眼衣原体进行生殖道沙眼衣原体检测的女性宫颈分泌物标本711例，生殖门诊2014年6月至2015年4月期间进行孕前检查的女性宫颈分泌物样本711例。分别用3种方法[实时荧光聚合酶链反应法（FQ—PCR）、免疫层析法及酶法]对样本进行检测，每例患者取3个拭子，用生理盐水洗脱混匀后均分为3份，对所得数据进行统计学分析。结果实时荧光PCR试剂检测妇科门诊与生殖门诊样本阳性率分别为9．98％（71／711）和4．22％（30／711）；酶法试剂结果分别为10．83％（77／711）和5．06％（36／711）；免疫层析法试剂检测结果分别为4．78％（34／711）和2．11％（15／711）。3种方法学试剂检测沙眼衣原体阳性率妇科门诊均高生殖门诊。与实时荧光PCR试剂检测结果相比，酶法试剂检测灵敏度为85．1％（86／101），特异性为98．0％（1294／1321），免疫层析发试剂检测灵敏度为45．5％（46／101），特异性为99．8％（1318／1321）。结论妇科门诊来源的样本与生殖门诊来源的样本检测阳性率差异有统计学意义（P〈0．05），免疫层析法试剂有较高的特异性，但灵敏度较差；酶法试剂检测灵敏度高于胶体金试剂，特异性与其相当。

Objective To compare the positive rates of Chlamydia trachomatis （CT） in gynecological clinic and reproductive medicine clinic by detecting cervical samples from two clinics with three assays of different methodologies. To determine the performances of enzyme assay and immunochromatography （ICA） assay compared to the real-time PCR assay. Methods Seven hundred and eleven samples of gynecological clinic from May 2014 to May 2015 and 711 samples of reproductive medicine clinic from June 2014 to April 2015 were collected in Henan Province People＇s Hospital. Three cervical swabs were collected from each participant. The three samples were eluted with saline water then mixed. The samples were detected with three methodologies respectively after dividing the mixture into three. Results The positive rates of CT in gynecological clinic and reproductive medicine clinic were 9. 98% （71/711 ） and 4. 22% （30/711） by real-time PCR assay, 10. 83% （77/711） and 5.06% （36/711） by enzyme assay, 4.78% （34/711） and 2. 11% （15/711） by ICA assay. The sensitivity and specificity were 85. 1% （86/101） and 98.0% （1 294/1 321 ） by enzyme assay. The sensitivity of ICA assay was 45.5% （46/101） and specificity was 99.8% （ 1 318/1 321 ） compared to the real-time PCR assay. Conclusion The positive rate of CT in gynecological clinic was markedly higher than that in reproductive medicine clinic （ P 〈 0. 05 ）. The ICA assay, while exhibiting a high specificity, had unacceptably low sensitivity compared to real-time PCR assay. The enzyme assay had higher sensitivity but slightly worse specificity.