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用于宫颈癌筛查中高危型人乳头瘤病毒阳性自我采样标本分流的细胞学反射检查:一项前瞻性队列研究。

Reflex cytology for triage of high-risk human papillomavirus positive self-sampled material in cervical cancer screening: a prospective cohort study.

机构信息

Department of Obstetrics and Gynaecology, Radboud Institute for Molecular Life Sciences, Radboud university medical center, Nijmegen, The Netherlands.

Department of Medical Microbiology, Radboud university medical center, Nijmegen, The Netherlands.

出版信息

BJOG. 2020 Dec;127(13):1656-1663. doi: 10.1111/1471-0528.16352. Epub 2020 Jul 3.

Abstract

OBJECTIVE

High-risk human papillomavirus (HrHPV)-positive women detected by self-sampling require an extra visit at the general practitioner for additional cytology testing, but the loss to follow up within this triage is substantial. The aim of this study was to evaluate the clinical utility of reflex cytology on hrHPV-positive self-samples for immediate stratification of women who need referral for colposcopy.

DESIGN

A prospective cohort study.

SETTING

Two Dutch cervical cancer-screening laboratories.

POPULATION

1014 screenees who tested hrHPV-positive on self-samples between 1 December 2018 and 1 August 2019.

METHODS

Self-samples were directly used for cytological analysis. Cytological and histological outcomes during follow up were obtained from the Dutch Pathology Registry (PALGA).

MAIN OUTCOME MEASURES

Test performance of reflex cytology on self-samples was determined for different thresholds and compared with physician-taken cytology and histological outcomes.

RESULTS

Reflex cytology on self-samples for detecting abnormal cytology showed a sensitivity of 26.4% (95% CI 21.8-31.3) and specificity of 90.5% (95% CI 87.7-92.8). Of all ≥CIN2 cases, 29.4% (95% CI 22.5-37.1) were detected with reflex cytology on self-samples. The positive predictive value for detection of ≥CIN2 was higher with cytology on self-collected samples than on physician-collected samples. Of women who were lost to follow up, 12.9% were found to have abnormal cytology on their self-sampled material.

CONCLUSION

Cytology testing is achievable on hrHPV-positive self-samples, could decrease the loss to follow up in screening and is easily implementable in the current clinical practice. Of all hrHPV-positive women with abnormal cytology on additional physician-collected samples, 26.4% could have been directly referred for colposcopy if triage with reflex cytology on self-sampled material had been performed.

TWEETABLE ABSTRACT

Reflex cytology for triage of hrHPV self-samples is of added value for direct referral of women for colposcopy.

摘要

目的

通过自我采样检测到高危型人乳头瘤病毒(HrHPV)阳性的女性需要在全科医生处进行额外的细胞学检测,但在此分诊过程中,大量女性会失去随访。本研究旨在评估即时分层需要转诊行阴道镜检查的 HrHPV 阳性自我采样者的细胞学检查在该策略中的临床应用价值。

设计

前瞻性队列研究。

设置

两个荷兰宫颈癌筛查实验室。

人群

2018 年 12 月 1 日至 2019 年 8 月 1 日期间自我采样检测到 HrHPV 阳性的 1014 名筛查者。

方法

直接使用自我采样进行细胞学分析。随访期间的细胞学和组织学结果均来自荷兰病理学登记处(PALGA)。

主要观察指标

不同临界值下自我采样的细胞学检查的检测性能,并与医生取样的细胞学和组织学结果进行比较。

结果

用于检测异常细胞学的自我采样的细胞学检查显示出 26.4%(95%CI,21.8%-31.3%)的敏感性和 90.5%(95%CI,87.7%-92.8%)的特异性。所有≥CIN2 病例中,有 29.4%(95%CI,22.5%-37.1%)通过自我采样的细胞学检查发现。自我采集样本的细胞学检查对检测≥CIN2 的阳性预测值高于医生采集样本。在失访的女性中,有 12.9%在自我采样材料中发现细胞学异常。

结论

在 HrHPV 阳性的自我采样中进行细胞学检测是可行的,可以减少筛查中的失访率,并且很容易在当前的临床实践中实施。如果在自我采样的材料中进行细胞学检查进行分流,则所有在额外医生采集样本中细胞学异常的 HrHPV 阳性女性中,有 26.4%可以直接转诊行阴道镜检查。

推文摘要

用于自我采样的 HrHPV 细胞学检查对直接转诊行阴道镜检查的女性具有附加价值。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7e57/7689810/3afe512c5545/BJO-127-1656-g001.jpg

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