Department of Women's Health, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
Department of Laboratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
Int J Gynaecol Obstet. 2018 Sep;142(3):359-364. doi: 10.1002/ijgo.12538. Epub 2018 Jun 25.
To investigate whether self-sampling is as reliable as professional sampling for HPV testing and genotype detection among postmenopausal women.
In the present prospective cross-sectional study, women in Örebro County, Sweden, who had high-risk HPV (hrHPV) and normal cytology results in exit screening tests conducted in between January 1, 2012, and December 31, 2014, were invited to follow-up screenings between February 24, 2015 and May 15, 2015, that included professional sampling and self-sampling. HPV genotypes were identified by a DNA-based assay that could detect 35 HPV genotypes. Findings between the different sampling methods were compared.
Of 143 women who participated, 119 returned a self-sample. Completely concordant results were observed in 67 of these samples when both hrHPV and low-risk HPV genotypes were analyzed. Overall, 99 (83.2%) women had the same clinically relevant finding from both sampling methods. Twenty women had discordant hrHPV results (hrHPV detected in 10 self-samples vs 10 professionally collected samples; Cohen κ 0.66, 95% confidence interval 0.53-0.80). There was no significant difference between the two sampling methods for clinically significant infections (P>0.99) or extended genotyping (P=0.827).
Postmenopausal women could be offered self-sampling devices to increase screening-program coverage while maintaining test quality.
研究绝经后妇女自我采样与专业采样在 HPV 检测和基因分型检测中的可靠性。
在本前瞻性横断面研究中,邀请瑞典厄勒布鲁县于 2012 年 1 月 1 日至 2014 年 12 月 31 日期间接受出口筛查试验且高危型 HPV(hrHPV)和细胞学正常的女性参加 2015 年 2 月 24 日至 5 月 15 日之间的随访筛查,包括专业采样和自我采样。通过可检测 35 种 HPV 基因型的基于 DNA 的检测方法确定 HPV 基因型。比较不同采样方法的结果。
143 名参与研究的女性中,有 119 名女性提交了自我采样。当同时分析 hrHPV 和低危型 HPV 基因型时,这些样本中有 67 个完全一致。总体而言,99(83.2%)名女性的两种采样方法具有相同的临床相关发现。20 名女性的 hrHPV 结果不一致(10 个自我样本和 10 个专业采集样本均检测到 hrHPV;Cohen κ 0.66,95%置信区间 0.53-0.80)。两种采样方法在临床显著感染(P>0.99)或扩展基因分型(P=0.827)方面无显著差异。
可以为绝经后妇女提供自我采样设备,在保持检测质量的同时提高筛查计划的覆盖率。