Alinity m HR HPV Assay: United States Clinical Trial Design and High-Risk Human Papillomavirus Prevalence.

IF 2.4 4区医学 Q2 OBSTETRICS & GYNECOLOGY

Journal of Lower Genital Tract Disease Pub Date : 2025-06-02 DOI:10.1097/LGT.0000000000000900

Mark Stoler, Richard Cullum, Danijela Lucic, Thomas Wright

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引用次数: 0

Abstract

Objective: The Alinity m HR HPV assay is a qualitative molecular assay that simultaneously detects high-risk human papillomavirus (hr HPV) genotypes HPV16, 18, and 45 and reports the 11 other hr HPV genotypes in 2 aggregates as other HR HPV A (HPV31, 33, 52, 58) and other HR HPV B (HPV35, 39, 51, 56, 59, 66, 68). Here, we describe the prevalence of hr HPV genotypes in the Alinity m HR HPV assay US clinical trial population stratified by age, cytology, and cervical disease status.

Materials and methods: This study included 11,532 women undergoing routine cervical cancer screening.

Results: Overall hr HPV positivity decreased with age. Other HR HPV B genotypes had the highest positivity followed by other HR HPV A, HPV16, HPV45, and HPV18. In the population with ≥atypical squamous cells of undetermined significance cytology, other HR HPV A and other HR HPV B genotypes had the highest positivity rates. HPV16 and other HR HPV A positivity rates were highest in specimens with ≥cervical intraepithelial neoplasia 3 by histology.

Conclusions: This analysis of primary screening participants in the Alinity m HR HPV assay US clinical trial demonstrates the benefits of including genotype-specific testing in cervical cancer screening programs.

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Alinity HR HPV检测：美国临床试验设计和高危人乳头瘤病毒流行。

目的：Alinity m HR HPV检测是一种定性的分子检测方法，可同时检测高危人乳头瘤病毒（HR HPV） HPV16、18和45基因型，并将其他11种HR HPV基因型分为2个聚集体，分别为其他HR HPV a （HPV31、33、52、58）和其他HR HPV B （HPV35、39、51、56、59、66、68）。在这里，我们描述了hr HPV基因型在Alinity m hr HPV检测美国临床试验人群中的流行情况，这些人群按年龄、细胞学和宫颈疾病状况分层。材料和方法：本研究包括11,532名接受常规宫颈癌筛查的妇女。结果：整体hr HPV阳性随年龄下降。其他HR HPV B基因型阳性率最高，其次是其他HR HPV A、HPV16、HPV45和HPV18。在细胞学意义不确定的非典型鳞状细胞≥的人群中，其他HR HPV A和其他HR HPV B基因型的阳性率最高。HPV16和其他HR HPV A在宫颈上皮内瘤变≥3的标本中组织学阳性率最高。结论：这项对Alinity m HR HPV检测美国临床试验的初步筛查参与者的分析表明，将基因型特异性检测纳入宫颈癌筛查计划是有益的。

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.