DDL Diagnostic Laboratory, Rijswijk, Netherlands.
J Clin Microbiol. 2012 Dec;50(12):3937-43. doi: 10.1128/JCM.01506-12. Epub 2012 Sep 26.
Primary screening using high-risk human papillomavirus (hrHPV) detection has been suggested as a way of improving cervical cancer prevention. Women currently not attending screening (nonresponders) are more likely to participate when given the opportunity of self-sampling for hrHPV testing. The Evalyn Brush is a new cervicovaginal self-sampling device, developed specifically to meet women's demands, which is user-friendly and easy to use. The aims of this study were to investigate agreement of hrHPV detection by two PCR methods between the Evalyn Brush and physician-obtained samples and to study women's acceptance of this self-sampling device. Each of 134 women visiting the gynecology outpatient clinic collected a self-obtained sample (self-sample) and completed a questionnaire. The brush was stored dry. After self-sampling, a trained physician obtained a conventional cervical cytology specimen in ThinPrep medium. HrHPV detection was performed using the SPF(10)-DEIA-LiPA(25) and GP5+/6+-LQ-test. The overall agreement for hrHPV detection using SPF(10)-DEIA-LiPA(25) between the self-sample and the physician-taken sample was 85.8% (kappa value, 0.715; 95% confidence interval [CI], 0.597 to 0.843; P = 1.000). The overall agreement for hrHPV detection using GP5+/6+-LQ between the self-sample and the physician-taken sample was 86.6% (kappa value, 0.725; 95% CI, 0.607 to 0.843; P = 0.815). Ninety-eight percent of the women rated their experience as good to excellent. Moreover, 95% of women preferred self-sampling to physician sampling. Self-sampling using the dry Evalyn Brush system is as good as a physician-taken sample for hrHPV detection and is highly acceptable to women. To validate this self-sampling device for clinical use, a large screening cohort should be studied.
初步筛查采用高危型人乳头瘤病毒(hrHPV)检测,被认为是改善宫颈癌预防的一种方法。当有机会进行 hrHPV 检测的自我采样时,目前未参加筛查的女性(未响应者)更有可能参与。Evalyn 刷是一种新的宫颈阴道自我采样装置,专门为满足女性需求而开发,使用方便。本研究的目的是研究两种 PCR 方法对 Evalyn 刷和医生获得的样本中 hrHPV 检测的一致性,并研究女性对这种自我采样装置的接受程度。每位 134 名就诊妇科门诊的女性均采集一份自我采集样本(自我样本)并完成一份问卷。刷子干燥保存。自我采样后,一名经过培训的医生用 ThinPrep 介质获得常规宫颈细胞学标本。使用 SPF(10)-DEIA-LiPA(25)和 GP5+/6+-LQ 检测进行 hrHPV 检测。使用 SPF(10)-DEIA-LiPA(25)进行 hrHPV 检测时,自我样本和医生采集样本之间的总体一致性为 85.8%(kappa 值为 0.715;95%置信区间[CI]为 0.597 至 0.843;P = 1.000)。使用 GP5+/6+-LQ 进行 hrHPV 检测时,自我样本和医生采集样本之间的总体一致性为 86.6%(kappa 值为 0.725;95%CI 为 0.607 至 0.843;P = 0.815)。98%的女性对她们的体验评价为好到极好。此外,95%的女性更喜欢自我采样而不是医生采样。使用干燥的 Evalyn 刷系统进行自我采样与医生采集样本一样适用于 hrHPV 检测,并且非常受女性欢迎。为了验证这种自我采样装置的临床应用,应该对一个大型筛查队列进行研究。