比较细胞学、HPV16/18 基因分型和 PAX1/SOX1 甲基化在高危 HPV 阳性宫颈样本分类中的表现。对从大规模前瞻性随机对照试验中收集的档案样本进行回顾性分析。招募了 HPV 阳性女性来自一般宫颈筛查人群。403 例 HPV 阳性样本，其中包括 113 例正常样本、173 例低度宫颈上皮内瘤变 (LG-CIN)、114 例 HG-CIN 和 3 例宫颈癌。所有样本均通过液基细胞学、HPV 基因分型和 PAX1/SOX1 甲基化进行评估。高级别 (HG) 癌前宫颈癌的 AUC（曲线下面积）、细胞学、HPV16/18 基因分型和 PAX1/SOX1 甲基化的敏感性和特异性在检测 HG 病变 (CIN2) 时，PAX1 比细胞学和 HPV16/18 基因分型更敏感。 PAX1、SOX1、细胞学和 HPV16/18 的敏感性分别为 73.5% (95% CI: 65.5-81.5)、41.9% (95% CI: 32.9-50.8)、48.7% (95% CI: 39.7-57.8) 和 36.8 %（95% CI：28.0-45.5），其特异性分别为 70.3%（95% CI：65.0-75.6）、83.6%（95% CI：79.3-87.9）、77.6%（95% CI：72.8）分别为 -82.5）和 67.1%（95% CI：61.7-72.6）。总体而言，PAX1 的 AUC 最好，为 0.72。将 SOX1 添加到 PAX1 并没有改善 AUC (0.68)。对基线时没有 HG 病变的 322 名女性进行了两轮筛查的随访。与基线细胞学正常或 HPV16/18 阴性的女性相比，基线 PAX1 正常的女性出现 HG 病变的人数较少（分别为 8.4% vs. 14.5% 和 17.5%）。在 HPV 阳性女性中，PAX1 分类转诊至阴道镜检查可能会导致 HG 病变。优于细胞学和 HPV16/18 基因分型。© 2024 作者。 BJOG：约翰·威利出版的国际妇产科杂志

To compare the performance of cytology, HPV16/18 genotyping and PAX1/SOX1 methylation for the triage of high-risk HPV-positive cervical samples.Retrospective analyses of archival samples collected from a large-scale prospective randomised controlled trial.HPV-positive women recruited from the general cervical screening population.403 HPV-positive samples including 113 normal, 173 low-grade cervical intraepithelial neoplasia (LG-CIN), 114 HG-CIN and three cervical cancers. All samples were assessed by liquid-based cytology, HPV genotyping and PAX1/SOX1 methylation.AUC (area under the curve), sensitivity and specificity for cytology, HPV16/18 genotyping and PAX1/SOX1 methylation for high-grade (HG) premalignant cervical lesions.PAX1 was more sensitive than cytology and HPV16/18 genotyping in detecting a HG lesion (CIN2+). The sensitivity for PAX1, SOX1, cytology and HPV16/18 were 73.5% (95% CI: 65.5-81.5), 41.9% (95% CI: 32.9-50.8), 48.7% (95% CI: 39.7-57.8) and 36.8% (95% CI: 28.0-45.5), respectively, and their respective specificities were 70.3% (95% CI: 65.0-75.6), 83.6% (95% CI: 79.3-87.9), 77.6% (95% CI: 72.8-82.5) and 67.1% (95% CI: 61.7-72.6), respectively. Overall, PAX1 gave the best AUC at 0.72. Adding SOX1 to PAX1 did not improve the AUC (0.68). Three hundred and twenty-two women who did not have a HG lesion at baseline were followed up for two rounds of screening. Fewer women developed a HG lesion with a normal baseline PAX1 compared to women with a normal baseline cytology or negative HPV16/18 (8.4% vs. 14.5% and 17.5%, respectively).PAX1 triage for referral to colposcopy in HPV-positive women may be superior to cytology and HPV16/18 genotyping.© 2024 The Author(s). BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.