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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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.