Cross-Sectional Study on the Detection of HPV Infections for Cervical Cancer Screening Using a Self-Sampling Device.

IF 2.4 4区医学 Q2 OBSTETRICS & GYNECOLOGY

Journal of Lower Genital Tract Disease Pub Date : 2025-03-05 DOI:10.1097/LGT.0000000000000884

Marta Arnáez de la Cruz, Anna Martin Marti, Stela Álvarez Fernandez, Marta Gurrea Soteras, Maria Dolores Comes García, Heidi Mauricio Aviñó, Julia Haba Moya, Santiago Domingo Del Pozo, Mireya Prieto Rodríguez

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引用次数: 0

Abstract

Objectives: This study evaluates a new vaginal self-sampling device for high-risk human papillomavirus (HR-HPV) detection compared to clinician-collected samples using real-time polymerase chain reaction (PCR).

Methods: A total of 345 women aged between 23 and 72 were enrolled in this study. After receiving information about the study, women were provided with a vaginal collecting device to collect self-sample, and then a medical professional collected the cervical sample. All the clinician-collected samples were processed using the Cobas 4800 HPV assay, and the self-samples were processed with the automated MAIS extraction system. These results were used to compare the new device's performance to the clinician-collected cervical samples. All the clinician-collected samples were also analyzed with a new HPV screening assay to compare the performance of this assay on 2 different types of samples.

Results: Overall agreement for detecting any HR-HPV between clinician-collected samples and self-samples was 93.7% with a Cohen κ coefficient of 0.842. As both assays allow to identify genotypes 16, 18 and to detect the same 12 HR-HPV genotypes in a pool, we analyzed the agreement between self- and clinician-collected samples by genotypes and it was shown to be also excellent for HPV16 and the pool of other HR-HPV.

Conclusions: This self-sampling device has demonstrated detection rates that are comparable to those of samples collected by clinicians.

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使用自采样装置检测宫颈癌筛查中HPV感染的横断面研究。

目的：本研究评估了一种新的阴道自采样装置用于高风险人乳头瘤病毒（HR-HPV）检测，并与临床采集的实时聚合酶链反应（PCR）样本进行了比较。方法：共有345名年龄在23 ~ 72岁之间的女性参加了这项研究。在获得有关研究的信息后，为妇女提供阴道收集装置来收集自己的样本，然后由医学专业人员收集宫颈样本。所有临床采集的样本均采用Cobas 4800 HPV检测处理，自体样本采用MAIS自动提取系统处理。这些结果用于将新装置的性能与临床收集的宫颈样本进行比较。所有临床收集的样本也用一种新的HPV筛查方法进行分析，以比较该方法在两种不同类型样本上的表现。结果：临床采集样本与自身样本的HR-HPV检测总体一致性为93.7%，Cohen κ系数为0.842。由于这两种方法都可以识别基因型16和18，并在一个池中检测相同的12种HR-HPV基因型，我们分析了自我和临床收集的基因型样本之间的一致性，结果表明它对HPV16和其他HR-HPV池也很好。结论：这种自采样装置的检出率与临床医生收集的样本相当。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Lower Genital Tract Disease OBSTETRICS & GYNECOLOGY-

CiteScore

6.80

自引率

8.10%

发文量

158

审稿时长

6-12 weeks

期刊介绍： The Journal of Lower Genital Tract Disease is the source for the latest science about benign and malignant conditions of the cervix, vagina, vulva, and anus. The Journal publishes peer-reviewed original research original research that addresses prevalence, causes, mechanisms, diagnosis, course, treatment, and prevention of lower genital tract disease. We publish clinical guidelines, position papers, cost-effectiveness analyses, narrative reviews, and systematic reviews, including meta-analyses. We also publish papers about research and reporting methods, opinions about controversial medical issues. Of particular note, we encourage material in any of the above mentioned categories that is related to improving patient care, avoiding medical errors, and comparative effectiveness research. We encourage publication of evidence-based guidelines, diagnostic and therapeutic algorithms, and decision aids. Original research and reviews may be sub-classified according to topic: cervix and HPV, vulva and vagina, perianal and anal, basic science, and education and learning. The scope and readership of the journal extend to several disciplines: gynecology, internal medicine, family practice, dermatology, physical therapy, pathology, sociology, psychology, anthropology, sex therapy, and pharmacology. The Journal of Lower Genital Tract Disease highlights needs for future research, and enhances health care. The Journal of Lower Genital Tract Disease is the official journal of the American Society for Colposcopy and Cervical Pathology, the International Society for the Study of Vulvovaginal Disease, and the International Federation of Cervical Pathology and Colposcopy, and sponsored by the Australian Society for Colposcopy and Cervical Pathology and the Society of Canadian Colposcopists.