Department of Pathology, VU University Medical Center, Amsterdam, The Netherlands.
Int J Cancer. 2012 Mar 1;130(5):1128-35. doi: 10.1002/ijc.26128. Epub 2011 May 30.
We evaluated the effect of offering brush-based vaginal self-sampling for high-risk human papillomavirus (hrHPV) testing to non-attendees of the cervical screening program on response rate, compliance to follow-up and cervical intraepithelial neoplasia grade 2 or 3 (CIN2+/CIN3+) yield. In addition, concordance of hrHPV test results between physician-taken cervical scrapes and vaginal self-samples was determined. A total of 26,409 nonattending women were randomly assigned to receive a vaginal brush device for hrHPV testing by Hybrid Capture-2 method (i.e., self-sampling group, n = 26,145) or a reinvitation for regular cytology-based screening (i.e., recall control group, n = 264). hrHPV-positive self-sampling responders were invited for a physician-taken scrape for cytology and blinded hrHPV testing. If cytology was abnormal, women were referred for colposcopy. Response rate in the self-sampling group was significantly increased compared to the recall control group (30.8% versus 6.5%; p < 0.001). The concordance rate between hrHPV detection in self-samples and corresponding physician-taken cervical scrape samples was 68.8%. Amongst women with CIN3+ and CIN2+, the concordance rates in hrHPV positivity between both samples were 95.5% and 93.8%, respectively. Adherence at baseline to cytology triage of hrHPV-positive self-sampling women (89.1%) and colposcopy referral of those with abnormal cytology (95.8%) was high. The CIN2+/CIN3+/carcinoma yields were 1.5%, 1.0% and 0.1%, respectively, in self-sampling responders. In conclusion, offering hrHPV testing on self-sampled vaginal material with a brush device to non-attendees significantly increases the attendance to the regular screening program, yields hrHPV test results that are in very good concordance with those of physician-taken scrapes in women with CIN2+/CIN3+, and is effective in detecting CIN2+/CIN3+.
我们评估了向未能参加宫颈癌筛查项目的高危型人乳头瘤病毒（hrHPV）检测的女性提供巴氏刷阴道自采样对反应率、对随访的依从性以及 2 级或 3 级宫颈上皮内瘤变（CIN2+/CIN3+）检出率的影响。此外，还确定了医生取样的宫颈刮片与阴道自采样之间 hrHPV 检测结果的一致性。共有 26409 名未参加的女性被随机分配接受基于杂交捕获 2 法的 hrHPV 检测的巴氏刷设备（即自采样组，n=26145）或常规细胞学为基础的筛查的重新邀请（即召回对照组，n=264）。hrHPV 阳性的自采样应答者被邀请进行医生取样的刮片细胞学和盲法 hrHPV 检测。如果细胞学异常，女性将被转诊行阴道镜检查。与召回对照组相比，自采样组的反应率显著增加（30.8%比 6.5%；p<0.001）。自采样与相应的医生取样宫颈刮片样本中 hrHPV 检测的一致性率为 68.8%。在患有 CIN3+和 CIN2+的女性中，两种样本中 hrHPV 阳性的一致性率分别为 95.5%和 93.8%。hrHPV 阳性自采样女性的细胞学分流（89.1%）和异常细胞学的阴道镜转诊（95.8%）的依从性高。自采样应答者的 CIN2+/CIN3+/癌的检出率分别为 1.5%、1.0%和 0.1%。总之，向未能参加的女性提供巴氏刷阴道自采样的 hrHPV 检测显著增加了对常规筛查项目的参与率，在患有 CIN2+/CIN3+的女性中，hrHPV 检测结果与医生取样的刮片结果非常一致，并且可以有效检测出 CIN2+/CIN3+。
