中华皮肤科杂志 ›› 2021, Vol. 54 ›› Issue (9): 814-818.doi: 10.35541/cjd.20200997

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性传播疾病门诊就诊者1 475例尿液和尿道/宫颈拭子沙眼衣原体DNA检测结果分析

王焕丽1    杨斌2    郭庆3    龚子鉴4    曾抗5    杨文林6    方锐华7    朱慧兰8    毕超9    何婉苹10    杨日东1    汤少开10    王建琴8   

  1. 1广州市皮肤病防治所性病科  510095；2南方医科大学皮肤病医院皮肤科，广州  510091；3中山大学孙逸仙纪念医院皮肤科，广州  510120；4中山大学附属第三医院皮肤科，广州  510630；5南方医科大学南方医院皮肤科，广州  510515；6广州医科大学附属第二医院皮肤科  510260；7广州市第一人民医院皮肤科  510180；8广州市皮肤病防治所皮肤科  510095；9广州市皮肤病防治所检验科  510095；10广州市皮肤病防治所预防保健科  510095
  • 收稿日期:2020-10-12 修回日期:2021-05-19 发布日期:2021-09-02
  • 通讯作者: 王建琴 E-mail:jianqinwang@foxmail.com
  • 基金资助:
    广州市卫生计生科技重大项目（20181A031003）

Detection of Chlamydia trachomatis DNA in urine and urethral/cervical swab samples: analysis of results from 1 475 outpatients attending sexually transmitted disease clinics

Wang Huanli1, Yang Bin2, Guo Qing3, Gong Zijian4, Zeng Kang5, Yang Wenlin6, Fang Ruihua7, Zhu Huilan8, Bi Chao9, He Wanping10, Yang Ridong1, Tang Shaokai10, Wang Jianqin8   

  1. 1Department of Venereology, Guangzhou Institute of Dermatology, Guangzhou 510095, China; 2Department of Dermatology, Dermatology Hospital of Southern Medical University, Guangzhou 510091, China; 3Department of Dermatology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou 510120, China; 4Department of Dermatology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou 510630, China; 5Department of Dermatology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China; 6Department of Dermatology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou 510260, China; 7Department of Dermatology, Guangzhou First People′s Hospital, Guangzhou 510180, China; 8Department of Dermatology, Guangzhou Institute of Dermatology, Guangzhou 510095, China; 9Department of Laboratory Medicine, Guangzhou Institute of Dermatology, Guangzhou 510095, China; 10Department of Prevention and Health Care, Guangzhou Institute of Dermatology, Guangzhou 510095, China
  • Received:2020-10-12 Revised:2021-05-19 Published:2021-09-02
  • Contact: Wang Jianqin E-mail:jianqinwang@foxmail.com
  • Supported by:
    Major Scientific and Technological Projects of Health and Family Planning in Guangzhou（20181A031003）

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摘要： 【摘要】 目的 比较尿液法与尿道/宫颈拭子法检测生殖道沙眼衣原体（CT）DNA阳性率的差异。方法 2018年12月至2019年12月，广州市皮肤病防治所性病科等7个医疗单位共收集性传播疾病门诊初诊者1 475例，男1 118例、女357例。依次采集每例患者尿道/宫颈拭子、尿液标本各1份，采用实时荧光PCR法检测尿液和拭子标本中CT-DNA，配对χ2检验比较2种标本CT-DNA阳性率。采用随机或固定效应Meta分析对7个医疗单位的尿液、拭子标本CT-DNA阳性率进行异质性检验及合并。结果 4个医疗单位尿液标本CT-DNA阳性率均高于拭子标本（均P < 0.05），而3个医疗单位2种标本CT-DNA阳性率差异无统计学意义（均P > 0.05）。不同医疗单位间尿液和拭子标本CT-DNA阳性检出率异质性I 2分别为78.6%（95% CI：55.9% ~ 89.6%）、73.7%（95% CI：43.7% ~ 87.7%）；经Meta合并，尿液标本CT-DNA总阳性率为10.8%（95% CI：7.2% ~ 15.9%），显著高于拭子标本（7.8%，95% CI：4.9% ~ 12.1%；χ2 = 39.2，P < 0.05）。以拭子标本CT-DNA检测法为对照，尿液标本CT-DNA检测法的敏感性为97.0%（128/132），特异性为96.3%（1 293/1 343），阳性预测值为71.9%（128/178），阴性预测值为99.7%（1 293/1 297），符合率为96.3%（1 421/1 475）。1 118例男性尿液CT-DNA阳性率为11.0%（95% CI：7.2% ~ 16.5%），显著高于拭子CT-DNA阳性率（7.6%，95% CI：4.9% ~ 11.8%；χ2 = 34.3，P < 0.05）。357例女性尿液CT-DNA阳性率（11.9%，95% CI：7.7% ~ 17.9%）与拭子CT-DNA阳性率（10.4%，95% CI：7.6% ~ 14.0%）差异无统计学意义（χ2 = 3.2，P > 0.05）。结论 尿液CT-DNA阳性率高于或持平于拭子CT-DNA阳性率，采用尿液标本检测CT-DNA具有取材方便、无创、无痛苦、成本低等特点，值得临床推广。

关键词: 沙眼衣原体, 核酸扩增技术, 尿, 拭子

Abstract: 【Abstract】 Objective To compare the detection rate of genital Chlamydia trachomatis （CT） DNA between urine and urethral/cervical swab samples. Methods From December 2018 to December 2019, a total of 1 475 outpatients were collected from sexually transmitted disease clinics in 7 medical institutions, such as Department of Venereology, Guangzhou Institute of Dermatology, including 1 118 males and 357 females. One urethral/cervical swab sample and one urine sample were collected successively from each patient. Real-time fluorescence-based PCR was performed to detect CT DNA in urine and urethral/cervical swab samples, and paired chi-square test was used to compare the positive rate of CT DNA between the 2 kinds of samples. Random- or fixed-effect meta-analysis was conducted for the test of heterogeneity and merging of positive rates of CT DNA in the urine and urethral/cervical swabs among 7 medical institutions. Results The positive rate of CT DNA in the urine samples was significantly higher than that in the swab samples from 4 medical institutions （all P < 0.05）, while there was no significant difference in the positive rate of CT DNA between the 2 kinds of samples from 3 medical institutions （all P > 0.05）. The heterogeneity （I 2） estimates of the CT-DNA positive rate in urine and swab samples among different medical institutions were 78.6% （95% CI: 55.9% - 89.6%） and 73.7% （95% CI: 43.7% - 87.7%）, respectively; meta-analysis showed that the total merged positive rate of CT DNA in the urine samples was 10.8% （95% CI: 7.2% - 15.9%）, which was significantly higher than that in the swab samples （7.8%, 95% CI: 4.9% - 12.1%; χ2 = 39.2, P < 0.05）. Compared with the swab sample-based CT-DNA detection method, the sensitivity, specificity, positive predictive value, negative predictive value and consistency rate of the urine sample-based CT-DNA detection method were 97.0% （128/132）, 96.3% （1 293/1 343）, 71.9% （128/178）, 99.7% （1 293/1 297）, and 96.3% （1 421/1 475）, respectively. The positive rate of CT DNA in the urine samples from 1 118 male patients was 11.0% （95% CI: 7.2% - 16.5%）, which was significantly higher than that in the swab samples （7.6%, 95% CI: 4.9% - 11.8%; χ2 = 34.3, P < 0.05）. There was no significant difference in the positive rate of CT DNA between the urine （11.9%, 95% CI: 7.7% - 17.9%） and cervical swab samples from 357 female patients （10.4%, 95% CI: 7.6% - 14.0%; χ2 = 3.2, P > 0.05）. Conclusions The positive rate of CT DNA in urine samples is higher than or similar to that in urethral/cervical swab samples. The urine sample-based CT-DNA detection method has characteristics of convenience, non-invasiveness, painlessness and low cost, and is worthy of clinical promotion.

Key words: Chlamydia trachomatis, Nucleic acid amplification techniques, Urine, Swab