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用于人乳头瘤病毒检测的无防腐剂阴道自我采样具有良好的敏感性。

Vaginal self-sampling without preservative for human papillomavirus testing shows good sensitivity.

机构信息

Department of Obstetrics and Gynaecology, Skane University Hospital, Lund University, Sweden.

出版信息

J Clin Virol. 2013 Jan;56(1):52-6. doi: 10.1016/j.jcv.2012.09.002. Epub 2012 Sep 25.

DOI:10.1016/j.jcv.2012.09.002
PMID:23017435
Abstract

BACKGROUND

Several strategies have been used to reach non-attending women in organized cervical-cancer-screening programs, with varying success. Self-sampling (SS) for HPV is effective for increasing coverage in screening programs, but requires expensive commercial sampling kits.

OBJECTIVE

We aimed to evaluate if vaginal SS, without commercial preservatives was adequate for HPV testing.

STUDY DESIGN

Women with abnormal cervical smears as determined from the organized screening program were invited to a colposcopy clinic. The 121 women were asked to insert a cotton swab into the vagina and rotate it, put the cotton swab into a sterile cryotube, break the upper part of the stick and put the cap on. Thereafter, the gynaecologist collected a liquid based cytology (LBC) sample. The presence of HPV-types in SS and LBC samples was analysed with PCR and luminex-based typing.

RESULTS

High-risk-HPV (hr-HPV) DNA was found in 65 of the tested 108 SS (60%; 95% CI 0.50-0.69), whereas LBC found hr-HPV in 64/108 samples (59%; 95% CI 0.49-0.69). The agreement between sampling with SS and LBC was good, kappa value 0.67 (95% CI; 0.53-0.81). The sensitivity for SS with hr-HPV to find HSIL was 77% (95% CI; 62-91%), specificity 47% (95% CI; 35-59%) [corrected] and the sensitivity for LBC with hr-HPV to find HSIL was 79% (95% CI 66-93%), specificity 50% (95% CI; 38-62%). [corrected]

CONCLUSIONS

This new vaginal self-sampling method detects hr-HPV-infections with similar sensitivity as a cervical smear taken by a gynaecologist. This self-sampling method is cost-effective and well tolerated, and the kit is suitable for regular mail transport.

摘要

背景

为了提高组织性宫颈癌筛查计划的覆盖率,已经尝试了多种策略来接触未参加的女性,但效果各异。HPV 自我采样(SS)对于增加筛查计划的覆盖率是有效的,但需要昂贵的商业采样试剂盒。

目的

我们旨在评估未经商业防腐剂处理的阴道 SS 是否足以进行 HPV 检测。

研究设计

从组织性筛查计划中确定宫颈涂片异常的女性被邀请参加阴道镜检查。121 名女性被要求将棉签插入阴道并旋转,将棉签放入无菌冷冻管中,折断棒的上部并盖上盖子。之后,妇科医生采集液体基细胞学(LBC)样本。用 PCR 和基于 Luminex 的分型分析 SS 和 LBC 样本中 HPV 类型的存在。

结果

在测试的 108 个 SS 中,有 65 个(60%;95%CI 0.50-0.69)检测到高危型 HPV(hr-HPV)DNA,而 LBC 在 108 个样本中发现 64 个(59%;95%CI 0.49-0.69)。SS 与 LBC 采样的一致性良好,kappa 值为 0.67(95%CI;0.53-0.81)。SS 检测 hr-HPV 发现 HSIL 的灵敏度为 77%(95%CI;62-91%),特异性为 47%(95%CI;35-59%)[校正],LBC 检测 hr-HPV 发现 HSIL 的灵敏度为 79%(95%CI 66-93%),特异性为 50%(95%CI;38-62%)[校正]。

结论

这种新的阴道自我采样方法检测 hr-HPV 感染的敏感性与妇科医生采集的宫颈涂片相似。这种自我采样方法具有成本效益,且耐受性良好,试剂盒适合常规邮件运输。

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