High-risk human papillomavirus (hrHPV) testing is now the most recommended primary method for cervical cancer screening worldwide. Clinician-collected cervical sampling continues to be the main sampling method, but hrHPV vaginal self-sampling is an appealing alternative because of its greater acceptability and potentially higher cost-effectiveness. This study aimed to determine if hrHPV vaginal self-sampling is comparable to clinician-collected cervical sampling for detecting histologically confirmed high-grade cervical intraepithelial neoplasia (CIN2/3) as part of a cervical cancer screening program in Mexico. We analyzed data from 5,856 women screened during a hrHPV-based screening study. Clinical performance and diagnostic efficiency metrics were estimated for the two sampling methods for the CIN3 and CIN2+ endpoints, using three triage strategies: HPV16/18 genotyping, HPV16/18/33/58 extended genotyping, and HPV16/18/31/33/58 extended genotyping. hrHPV-positivity was found in 801 (13.7%) cervical and 897 (15.3%) vaginal samples. All women with hrHPV-positive samples were referred to colposcopy, which detected 17 total CIN3 cases before considering retrospective triage strategies. Using the HPV16/18/31/33/58 extended genotyping strategy, 245 women had hrHPV-positive cervical samples and 269 had hrHPV-positive vaginal samples. Ten CIN3 cases were detected each among women with hrHPV-positive cervical samples and among those with hrHPV-positive vaginal samples when using this strategy, with no significant differences in sensitivity and specificity observed. We observe that self- and clinician-collected sampling methods are comparable for detecting CIN3 and CIN2+ regardless of the triage strategy used. These findings can help public health officials to develop more cost-effective cervical cancer screening programs that maximize participation.

中文翻译：

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使用阴道与宫颈样本检测高级上皮内病变的 hrHPV 初步筛查的临床表现

高危人乳头瘤病毒 (hrHPV) 检测是目前全球最推荐的宫颈癌筛查主要方法。临床医生采集的宫颈取样仍然是主要的取样方法，但 hrHPV 阴道自我取样是一种有吸引力的替代方案，因为它具有更高的可接受性和潜在更高的成本效益。本研究旨在确定 hrHPV 阴道自我采样是否与临床医生采集的宫颈采样具有可比性，用于检测组织学证实的高级别宫颈上皮内瘤变 (CIN2/3)，作为墨西哥宫颈癌筛查计划的一部分。我们分析了在基于 hrHPV 的筛查研究中筛查的 5,856 名女性的数据。使用三种分类策略评估 CIN3 和 CIN2+ 终点的两种采样方法的临床表现和诊断效率指标：HPV16/18 基因分型、HPV16/18/33/58 扩展基因分型和 HPV16/18/31/33/58扩展基因分型。在 801 份 (13.7%) 宫颈样本和 897 份 (15.3%) 阴道样本中发现 hrHPV 阳性。所有 hrHPV 阳性样本的女性均接受阴道镜检查，在考虑回顾性分诊策略之前，总共检测到 17 例 CIN3 病例。使用 HPV16/18/31/33/58 扩展基因分型策略，245 名女性的宫颈样本为 hrHPV 阳性，269 名女性的阴道样本为 hrHPV 阳性。使用该策略时，在 hrHPV 阳性宫颈样本的女性和 hrHPV 阳性阴道样本的女性中各检测到 10 例 CIN3 病例，在敏感性和特异性方面没有观察到显着差异。我们观察到，无论使用何种分诊策略，自我采集和临床医生采集的采样方法在检测 CIN3 和 CIN2+ 方面具有可比性。这些发现可以帮助公共卫生官员制定更具成本效益的宫颈癌筛查计划，最大限度地提高参与度。