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高危型人乳头瘤病毒自我采样检测与荷兰宫颈筛查应答人群中医生取样涂片检测的比较:VERA 研究结果。

High-risk human papillomavirus detection in self-sampling compared to physician-taken smear in a responder population of the Dutch cervical screening: Results of the VERA study.

机构信息

Department of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, The Netherlands.

Department of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, The Netherlands.

出版信息

Prev Med. 2017 Aug;101:96-101. doi: 10.1016/j.ypmed.2017.05.021. Epub 2017 Jun 1.

Abstract

In 2017 the cervical cancer screening program in The Netherlands will be revised. Cervical smears will primarily be tested for the presence of high-risk human papillomavirus (hrHPV) instead of cytology, and vaginal self-sampling will be offered to non-responders. This includes a potential risk that part of the women who would otherwise opt for a cervical smear will wait for self-sampling. However, self-sampling for hrHPV in a responder population has never been studied yet. The aim of this study was to investigate the applicability and accuracy of self-sampling in detecting hrHPV in a screening responder population. A total of 2049 women, aged 30-60years, participating in the screening program in The Netherlands were included from April 2013 to May 2015. After they had their cervical smear taken, women self-collected a cervicovaginal sample with a brush-based device, the Evalyn Brush. Both the cervical smear and self-sample specimen were tested with the COBAS 4800 HPV platform. The hrHPV prevalence was 8.0% (95% CI 6.9-9.2) among the physician-taken samples, and 10.0% (95% CI 8.7-11.3) among the self-samples. There was 96.8% (95% CI 96.0-97.5) concordance of hrHPV prevalence between self-samples and physician-taken samples. Women in our study evaluated self-sampling as convenient (97.1%), user-friendly (98.5%), and 62.8% preferred self-sampling over a physician-taken sampling for the next screening round. In conclusion, self-sampling showed high concordance with physician-taken sampling for hrHPV detection in a responder screening population and highly acceptable to women. Implementation of HPV-self-sampling for the responder population as a primary screening tool may be considered.

摘要

2017 年,荷兰的宫颈癌筛查计划将进行修订。宫颈涂片将主要检测高危型人乳头瘤病毒(hrHPV)的存在,而不是细胞学检查,并且将向未应答者提供阴道自我采样。这可能会导致一部分原本选择宫颈涂片的女性等待自我采样。然而,在应答者人群中进行 hrHPV 的自我采样尚未进行研究。本研究的目的是调查自我采样在检测应答者人群中的 hrHPV 中的适用性和准确性。共有 2049 名年龄在 30-60 岁之间的女性参加了荷兰的筛查计划,于 2013 年 4 月至 2015 年 5 月入组。在接受宫颈涂片检查后,女性使用基于刷子的设备 Evalyn 刷子自行采集宫颈阴道样本。宫颈涂片和自我样本均使用 COBAS 4800 HPV 平台进行检测。在医生采集的样本中,hrHPV 患病率为 8.0%(95%CI 6.9-9.2),而在自我采集的样本中为 10.0%(95%CI 8.7-11.3)。自我样本和医生采集的样本之间的 hrHPV 患病率具有 96.8%(95%CI 96.0-97.5)的一致性。本研究中的女性认为自我采样方便(97.1%)、用户友好(98.5%),并且有 62.8%的女性更愿意在下一轮筛查中选择自我采样而不是医生采集的样本。总之,自我采样在应答者筛查人群中与医生采集的样本在检测 hrHPV 方面具有高度一致性,并且深受女性欢迎。可以考虑将 HPV 自我采样作为应答者人群的主要筛查工具。

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