Stoler Mark, Cullum Richard, Lucic Danijela, Wright Thomas
Professor Emeritus of Pathology and Clinical Gynecology, University of Virginia Health, Charlottesville, VA.
Molecular Diagnostics of Abbott, Des Plaines, IL.
J Low Genit Tract Dis. 2025 Jul 1;29(3):235-238. doi: 10.1097/LGT.0000000000000900. Epub 2025 Jun 2.
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, the authors 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.
This study included 11,532 women undergoing routine cervical cancer screening.
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.
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.
Alinity m HR HPV检测是一种定性分子检测方法，可同时检测高危型人乳头瘤病毒（hr HPV）基因型HPV16、18和45，并将其他11种hr HPV基因型归为2类进行报告，即其他HR HPV A（HPV31、33、52、58）和其他HR HPV B（HPV35、39、51、56、59、66、68）。在此，作者描述了在Alinity m HR HPV检测美国临床试验人群中，按年龄、细胞学和宫颈疾病状态分层的hr HPV基因型的流行情况。
本研究纳入了11532名接受常规宫颈癌筛查的女性。
总体hr HPV阳性率随年龄增长而降低。其他HR HPV B基因型的阳性率最高，其次是其他HR HPV A、HPV16、HPV45和HPV18。在意义不明确的非典型鳞状细胞≥的细胞学人群中，其他HR HPV A和其他HR HPV B基因型的阳性率最高。在组织学检查为宫颈上皮内瘤变3级及以上的标本中，HPV16和其他HR HPV A的阳性率最高。
对Alinity m HR HPV检测美国临床试验中的初筛参与者进行的这项分析表明，在宫颈癌筛查项目中纳入基因型特异性检测具有益处。
