人乳头瘤病毒 DNA 检测（自取样）与医生取样及细胞学检查在发展中国家用于宫颈癌筛查的效果比较如何？
Can human papillomavirus DNA testing of self-collected vaginal samples compare with physician-collected cervical samples and cytology for cervical cancer screening in developing countries?
机构信息
Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.
出版信息
Cancer Epidemiol. 2009 Dec;33(6):446-50. doi: 10.1016/j.canep.2009.10.013. Epub 2009 Nov 20.
BACKGROUND
To determine human papillomavirus (HPV) types by polymerase chain reaction (PCR)-reverse line blot assay and examine the concordance between HPV by Hybrid Capture 2 (HC2) and PCR on self-collected vaginal and physician-collected cervical samples and cytology.
METHODS
This was a cross-sectional study of 546 sexually active women aged > or =30 years with persistent vaginal discharge, intermenstrual or postcoital bleeding or an unhealthy cervix. Participants self-collected vaginal samples (HPV-S) and physicians collected cervical samples for conventional Pap smear and HPV DNA (HPV-P) testing and performed colposcopy, with directed biopsy, if indicated. HPV testing and genotyping was done by HC2 and PCR reverse line blot assay. Concordance between HC2 and PCR results of self- and physician-collected samples was determined using a Kappa statistic (kappa) and Chi-square test.
RESULTS
Complete data were available for 512 sets with 98% of women providing a satisfactory self-sample. PCR detected oncogenic HPV in 12.3% of self- and 13.0% of physician-collected samples. Overall, there was 93.8% agreement between physician-collected and self-samples (kappa=76.31%, 95% confidence interval [CI]: 64.97-82.29%, p=0.04)-complete concordance in 473 cases (57 positive, 416 negative), partial concordance in seven pairs and discordance in 32 pairs. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of self-sampling for detection of cervical intraepithelial neoplasia (CIN)2+ disease were 82.5%, 93.6%, 52.4% and 98.4%, respectively; for physician-sampling they were 87.5%, 93.2%, 52.2% and 98.9%, respectively; and for cytology they were 77.5%, 87.3%, 34.1% and 97.9%, respectively. Concordance between HC2 and PCR was 90.9% for self-samples (kappa=63.7%, 95% CI: 55.2-72.2%) and 95.3% for physician-collected samples (kappa=80.4%, 95% CI: 71.8-89.0%).
CONCLUSIONS
Self-HPV sampling compares favourably with physician-sampling and cytology. A rapid, affordable, HPV self-test kit can be used as the primary method of cervical cancer screening in low-resource situations.
背景
通过聚合酶链反应（PCR）-反向线印迹分析确定人乳头瘤病毒（HPV）类型，并检查自我采集的阴道和医生采集的宫颈样本与细胞学中 HPV 杂交捕获 2（HC2）和 PCR 的一致性。
方法
这是一项横断面研究，共纳入 546 名年龄> =30 岁、持续阴道分泌物、月经间期或性交后出血或宫颈不健康的有性生活的女性。参与者自行采集阴道样本（HPV-S），医生采集宫颈样本进行常规巴氏涂片和 HPV DNA（HPV-P）检测，并进行阴道镜检查，如果有指征则进行靶向活检。HPV 检测和基因分型采用 HC2 和 PCR 反向线印迹分析进行。使用 Kappa 统计量（kappa）和卡方检验确定 HC2 和自我及医生采集样本的 PCR 结果的一致性。
结果
512 组数据完整，98%的女性提供了满意的自我样本。PCR 在 12.3%的自我采集样本和 13.0%的医生采集样本中检测到致癌 HPV。总体而言，医生采集样本和自我采集样本之间的一致性为 93.8%（kappa=76.31%，95%置信区间[CI]：64.97-82.29%，p=0.04）-473 例完全一致（57 例阳性，416 例阴性），7 对部分一致，32 对不一致。自我采样检测宫颈上皮内瘤变（CIN）2+疾病的敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）分别为 82.5%、93.6%、52.4%和 98.4%；医生采样分别为 87.5%、93.2%、52.2%和 98.9%；细胞学检查分别为 77.5%、87.3%、34.1%和 97.9%。自我样本的 HC2 和 PCR 一致性为 90.9%（kappa=63.7%，95%CI：55.2-72.2%），医生采集样本为 95.3%（kappa=80.4%，95%CI：71.8-89.0%）。
结论
自我 HPV 采样与医生采样和细胞学检查相当。一种快速、经济实惠的 HPV 自我检测试剂盒可作为资源匮乏情况下宫颈癌筛查的主要方法。
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