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几内亚比绍感染人类免疫缺陷病毒女性首次排尿尿液和阴道自我采样用于高危型人乳头瘤病毒检测的可行性——一项多中心横断面研究

Feasibility of First-Void Urinary and Vaginal Self-Sampling for High-Risk Human Papillomavirus Testing Among Women Living With Human Immunodeficiency Virus in Guinea-Bissau-A Multicenter Cross-Sectional Study.

作者信息

Madsen Kia Lærke, Tranberg Mette, Nørgaard Pia, Medina Candida, Storgaard Merete, Vorsters Alex, Van Keer Severien, Hønge Bo Langhoff, Jespersen Sanne

机构信息

Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.

Aarhus University, Aarhus, Denmark.

出版信息

J Med Virol. 2025 Jul;97(7):e70466. doi: 10.1002/jmv.70466.

DOI:10.1002/jmv.70466
PMID:40590686
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12212020/
Abstract

In Guinea-Bissau, cervical cancer (CC) screening is unimplemented and data on high-risk human papillomavirus (hr-HPV) prevalence among women living with HIV (WLWH) are limited. This study assessed the acceptability of first-void urine (FVU) and vaginal self-sampling for HPV testing and the HPV prevalence and among WLWH in Guinea-Bissau. This multicenter cross-sectional study included a total of 498 WLWH aged 18-64 years. At nine HIV-clinics, women self-collected paired FVU and vaginal samples (VS), using the Colli-Pee and Evalyn Brush device, respectively. The Allplex HPV-HR assay was used for HPV DNA testing. Acceptability and preferences were assessed using questionnaires and hr-HPV genotype concordance was analyzed using Cohen's kappa (κ). Overall, 78% (n = 389/498) tested hr-HPV positive (FVU and/or VS). Good hr-HPV genotype concordance was observed (range 0.64-0.78) between sample types. HPV52 and HPV58 were the most prevalent genotypes (both 21%) followed by HPV66 and HPV16 (both 18%). Both modalities were well-accepted regarding comfort and ease of use, however, the urine device was preferred. Clinic-based FVU and VS self-sampling was feasible and well-accepted by WLWH, with urine sampling as the most preferred modality. The high hr-HPV prevalence underscores the urgency of integrating HPV-based CC screening and treatment into HIV care. Trial Registration: NCT05783167 (clinicaltrials.gov).

摘要

在几内亚比绍,宫颈癌(CC)筛查尚未实施,且关于感染艾滋病毒女性(WLWH)中高危人乳头瘤病毒(hr-HPV)流行率的数据有限。本研究评估了首次晨尿(FVU)和阴道自我采样用于HPV检测的可接受性,以及几内亚比绍感染艾滋病毒女性中的HPV流行率。这项多中心横断面研究共纳入了498名年龄在18至64岁之间的感染艾滋病毒女性。在9家艾滋病毒诊所,女性分别使用Colli-Pee和Evalyn Brush装置自行采集配对的首次晨尿样本和阴道样本(VS)。采用Allplex HPV-HR检测法进行HPV DNA检测。使用问卷评估可接受性和偏好,并使用科恩kappa(κ)分析hr-HPV基因型一致性。总体而言,78%(n = 389/498)的检测结果为hr-HPV阳性(首次晨尿样本和/或阴道样本)。在样本类型之间观察到良好的hr-HPV基因型一致性(范围为0.64 - 0.78)。HPV52和HPV58是最常见的基因型(均为21%),其次是HPV66和HPV16(均为18%)。两种采样方式在舒适度和易用性方面都得到了很好的接受,然而,尿液采样装置更受青睐。基于诊所的首次晨尿样本和阴道样本自我采样对感染艾滋病毒女性来说是可行的且被广泛接受,尿液采样是最受欢迎的方式。hr-HPV的高流行率凸显了将基于HPV的宫颈癌筛查和治疗纳入艾滋病毒护理的紧迫性。试验注册:NCT05783167(clinicaltrials.gov)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c577/12212020/f0e96f37473d/JMV-97-e70466-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c577/12212020/c4e6ae8e519a/JMV-97-e70466-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c577/12212020/a0096ba311be/JMV-97-e70466-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c577/12212020/f0e96f37473d/JMV-97-e70466-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c577/12212020/c4e6ae8e519a/JMV-97-e70466-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c577/12212020/a0096ba311be/JMV-97-e70466-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c577/12212020/f0e96f37473d/JMV-97-e70466-g001.jpg

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本文引用的文献

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High-risk human papillomavirus testing in first-void urine as a novel and non-invasive cervical cancer screening modality-a Danish diagnostic test accuracy study.首次晨尿中高危型人乳头瘤病毒检测作为一种新型非侵入性宫颈癌筛查方式——一项丹麦诊断试验准确性研究
BMC Med. 2025 Jun 2;23(1):327. doi: 10.1186/s12916-025-04149-0.
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Allplex HPV HR Detection assay fulfils all clinical performance and reproducibility validation requirements for primary cervical cancer screening.Allplex HPV HR Detection assay 满足了原发性宫颈癌筛查的所有临床性能和重现性验证要求。
J Clin Virol. 2024 Feb;170:105638. doi: 10.1016/j.jcv.2023.105638. Epub 2024 Jan 1.
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Effectiveness of Clinic-Based Patient-Led Human Papillomavirus DNA Self-Sampling among HIV-Infected Women in Uganda.
乌干达感染 HIV 的女性中基于诊所的患者主导的人乳头瘤病毒 DNA 自我采样的效果。
Int J Environ Res Public Health. 2023 Aug 20;20(16):6613. doi: 10.3390/ijerph20166613.
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HPV self-sampling versus healthcare provider collection on the effect of cervical cancer screening uptake and costs in LMIC: a systematic review and meta-analysis.HPV 自我采样与医疗保健提供者采集对中低收入国家宫颈癌筛查参与度和成本的影响:系统评价和荟萃分析。
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Utilizing first void urine for high-risk HPV testing for cervical cancer screening in HIV-positive women in Katete, Zambia.在赞比亚卡泰特,利用首段晨尿进行高危型 HPV 检测,用于 HIV 阳性妇女的宫颈癌筛查。
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