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HPV 检测方法在阴道自采样本和医生采集的宫颈样本中的分析性能:SCoPE 研究。

Analytical performance of HPV assays on vaginal self-collected vs practitioner-collected cervical samples: the SCoPE study.

机构信息

VCS Foundation, Carlton South, Victoria, Australia; VCS Pathology, Carlton South, Victoria, Australia; Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, Victoria, Australia; Department of Obstetrics and Gynaecology, University of Malaya, Kuala Lumpur, Malaysia.

VCS Foundation, Carlton South, Victoria, Australia; VCS Pathology, Carlton South, Victoria, Australia; Department of Pharmacology and Therapeutics, University of Melbourne, Parkville, Victoria, Australia; Department of Pathology, University of Malaya, Kuala Lumpur, Malaysia.

出版信息

J Clin Virol. 2020 Jun;127:104375. doi: 10.1016/j.jcv.2020.104375. Epub 2020 Apr 18.

DOI:10.1016/j.jcv.2020.104375
PMID:32361328
Abstract

BACKGROUND

In the last decade, human papillomavirus (HPV) testing has been evaluated extensively for cervical screening, with studies finding increased sensitivity compared to cytology. Another advantage of HPV based-screening is the ability to test vaginal samples that can be collected by women themselves. Self-collection has the potential to extend cervical screening coverage by increasing participation rates, particularly among women who are under-screened or have never screened. This could have a significant impact on cervical cancer prevention, as the majority of invasive cervical cancer cases occur among under-screened women. Both the Netherlands and Australia have transitioned their national programs from cytology to HPV as the primary screening test and both countries include a pathway for self-collection.

OBJECTIVES

We evaluated the relative sensitivity for HPV detection of self-collection compared with practitioner-collected cervical specimens in the context of the Australian National Cervical Screening Program (NCSP).

STUDY DESIGN

303 women aged ≥18 years attending a single tertiary referral centre took their own sample using a flocked-swab, and then had a practitioner-collected sample taken at colposcopy. All samples were tested at a single laboratory on the six PCR-based HPV assays which can be utilised in the NCSP; Roche cobas 4800 and cobas, Abbott RealTime, BD Onclarity, Cepheid Xpert, and Seegene Anyplex.

RESULTS

HPV16/18 results had high observed agreement between self- and practitioner-collected samples on all assays (range: 0.94-0.99), with good agreement for non-HPV16/18 oncogenic HPV types (range: 0.64-0.73).

CONCLUSIONS

Self-collection for HPV-based cervical screening shows good concordance and relative sensitivity when compared to practitionercollected samples across assays in the NCSP.

摘要

背景

在过去的十年中,人乳头瘤病毒(HPV)检测已广泛应用于宫颈癌筛查,研究发现其与细胞学相比具有更高的敏感性。HPV 检测的另一个优势是能够检测女性自行采集的阴道样本。自我采样有可能通过提高参与率来扩大宫颈癌筛查的覆盖面,尤其是在那些未接受过筛查或从未接受过筛查的女性中。这可能会对宫颈癌的预防产生重大影响,因为大多数侵袭性宫颈癌病例发生在未接受过筛查的女性中。荷兰和澳大利亚都已将其国家项目从细胞学转变为 HPV 作为主要筛查检测方法,两国都为自我采样开辟了途径。

目的

我们评估了澳大利亚国家宫颈癌筛查计划(NCSP)中,自我采集样本与医生采集样本相比 HPV 检测的相对敏感性。

研究设计

303 名年龄≥18 岁的女性在单一的三级转诊中心接受了采集,使用植绒拭子自行采集样本,然后在阴道镜检查时由医生采集样本。所有样本均在一个实验室中使用可用于 NCSP 的 6 种基于 PCR 的 HPV 检测方法进行检测;罗氏 cobas 4800 和 cobas、雅培 RealTime、BD Onclarity、Cepheid Xpert 和 Seegene Anyplex。

结果

所有检测方法上,HPV16/18 结果在自我采集和医生采集样本之间具有高度观察一致性(范围:0.94-0.99),对于非 HPV16/18 致癌 HPV 类型也具有良好的一致性(范围:0.64-0.73)。

结论

在 NCSP 中,与医生采集样本相比,HPV 检测的自我采集样本具有良好的一致性和相对敏感性。

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