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非窥阴器临床医生取样进行人乳头瘤病毒检测:老年女性的横断面研究。

Non-speculum clinician-taken samples for human papillomavirus testing: a cross-sectional study in older women.

机构信息

Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD, US.

Whipps Cross University Hospital, London, UK.

出版信息

Br J Gen Pract. 2022 Jul 28;72(721):e538-e545. doi: 10.3399/BJGP.2021.0708. Print 2022 Aug.

DOI:10.3399/BJGP.2021.0708
PMID:35667684
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9183459/
Abstract

BACKGROUND

Cervical cancer incidence and mortality are high in women aged ≥65 years, despite the disease being preventable by screening. Speculum-based screening can become more uncomfortable after the menopause.

AIM

To examine test performance and acceptability of human papillomavirus (HPV) testing on clinician-collected vaginal samples without a speculum (non-speculum).

DESIGN AND SETTING

Cross-sectional study in 11 GP practices and four colposcopy clinics in London, UK, between August 2017 and January 2019.

METHOD

Non-speculum and conventional (speculum) samples were collected from women aged ≥50 years attending for a colposcopy (following a speculum HPV-positive screening result) or women aged ≥35 years (with confirmed cervical intraepithelial neoplasia (CIN) 2+), and women aged 50-64 years attending routine screening. Sensitivity to CIN2+ was assessed among women with confirmed CIN2+ (colposcopy). Specificity to HPV relative to speculum sampling and overall concordance was assessed among women with negative cytology (routine screening).

RESULTS

The sensitivity of non-speculum sampling for detecting CIN2+ was 83.3% (95% confidence interval [CI] = 60.8 to 94.2) ( = 15/18). There was complete concordance among women with positive CIN2+ who had a speculum sample ≤91 days prior to the non-speculum sample ( = 12). Among 204 women with negative cytology, the specificity to HPV was 96.4% (95% CI = 92.7 to 98.5), with 96.6% concordant results (κ 72.4%). Seventy-one percent ( = 120/170) of women preferred a non-speculum sample for their next screen.

CONCLUSION

HPV testing on non-speculum clinician-taken samples is a viable approach that warrants further exploration in larger studies. Overall test performance was broadly comparable with that of self-sampling.

摘要

背景

尽管宫颈癌可以通过筛查来预防,但年龄在 65 岁及以上的女性中,宫颈癌的发病率和死亡率仍然很高。巴氏涂片检查在绝经后会变得更加不适。

目的

检查在没有阴道镜的情况下由临床医生采集的阴道样本(非阴道镜)进行人乳头瘤病毒(HPV)检测的性能和可接受性。

设计和设置

2017 年 8 月至 2019 年 1 月,在英国伦敦的 11 家全科医生诊所和 4 家阴道镜诊所进行了一项横断面研究。

方法

从因巴氏涂片阳性结果(阴道镜 HPV 阳性筛查结果)而接受阴道镜检查的年龄在 50 岁及以上的女性、年龄在 35 岁及以上(宫颈上皮内瘤变(CIN)2+)且已确诊 CIN2+的女性以及年龄在 50-64 岁之间接受常规筛查的女性中采集非阴道镜和常规(阴道镜)样本。在已确诊 CIN2+(阴道镜)的女性中评估 CIN2+的敏感性。在细胞学阴性(常规筛查)的女性中评估与阴道镜采样相比 HPV 的特异性和总体一致性。

结果

非阴道镜采样检测 CIN2+的敏感性为 83.3%(95%置信区间[CI] = 60.8 至 94.2)( = 15/18)。在阴道镜样本采集时间≤91 天的 CIN2+阳性女性中,结果完全一致( = 12)。在 204 例细胞学阴性的女性中,HPV 的特异性为 96.4%(95% CI = 92.7 至 98.5),结果一致率为 96.6%(κ 值 72.4%)。71%( = 120/170)的女性希望下一次筛查采用非阴道镜样本。

结论

在没有阴道镜的情况下,由临床医生采集的 HPV 检测是一种可行的方法,值得在更大规模的研究中进一步探索。总体测试性能与自我采样基本相当。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c32/9343024/7427bea8e0cd/bjgpaug-2022-72-721-e538-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c32/9343024/7427bea8e0cd/bjgpaug-2022-72-721-e538-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c32/9343024/7427bea8e0cd/bjgpaug-2022-72-721-e538-1.jpg

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