PAX1m/JAM3m 在非 16/18 人乳头瘤病毒阳性女性机会性宫颈癌筛查中的分诊表现：中国的一项多中心前瞻性研究。
Triage performance of PAX1m/JAM3m in opportunistic cervical cancer screening of non‒16/18 human papillomavirus-positive women: a multicenter prospective study in China.
发表日期：2024 Aug 16
作者：
Xiaojing Chen, Xitong Jin, Linghua Kong, Yuligh Liou, Pei Liu, Zhe Dong, Sijun Zhou, Bingli Qi, Jing Fei, Xiaoyan Chen, Guangwu Xiong, Yuchong Hu, Shikai Liu, Jianwei Zhou, Huafeng Shou, Lei Li
来源：
Epigenetics & Chromatin
摘要：
在本研究中，我们旨在验证 PAX1 和 JAM3 甲基化 (PAX1m/JAM3m) 测试作为检测非 16/18 高危人乳头瘤病毒中 3 级或更严重的宫颈上皮内瘤变 (CIN3 ) 的分类工具的性能。阳性患者（非 16/18 hrHPV ）。比较了液基细胞学 (LBC) 的分诊性能和检测 CIN3 的 PAX1m/JAM3m 测试。总共 1851 名参与者有宫颈组织学结果并纳入分析。对于意义不明或更差的非典型鳞状细胞 (LBC ≥ ASCUS) 和 PAX1m/JAM3m 检测，LBC 检测结果的敏感性/特异性分别为 90.1%/26.7% 和 84.8%/88.5%。 PAX1m/JAM3m( ) 在整个队列中具有最高的诊断 AUC（0.866，95% 置信区间 (CI) 0.837-0.896）。所有癌症 (n = 20) 均通过 PAX1m/JAM3m( ) 检测。与LBC ≥ ASCUS相比，PAX1m/JAM3m( )使需要转诊进行阴道镜检查的患者数量减少了57.21%（74.66% vs. 17.45%）。 LBC ≥ ASCUS 和 PAX1m/JAM3m( ) 检测 CIN3 的优势比分别为 3.3 (95% CI 2.0-5.9) 和 42.6 (27.1-69.6) (p < 0.001)。 LBC ≥ ASCUS 或 PAX1m/JAM3m( ) 组合略微提高了诊断敏感性（98.0%，95% CI：95.8-100%）和转诊率（77.09%），但降低了诊断特异性（24.8%，22.7-26.8%） ).在非 16/18 hrHPV( ) 女性中，PAX1m/JAM3m 在检测 CIN3 方面优于细胞学。与 LBC ≥ ASCUS 相比，PAX1m/JAM3m( ) 显着减少了转诊阴道镜的数量，且不影响诊断敏感性。© 2024。作者。
In this study, we aimed to validate the performance of the PAX1 and JAM3 methylation (PAX1m/JAM3m) test as a triage tool for detecting cervical intraepithelial neoplasia grade 3 or worse (CIN3 +) in non-16/18 high-risk human papillomavirus-positive patients (non-16/18 hrHPV +).The triage performance of liquid-based cytology (LBC) and the PAX1m/JAM3m test for detecting CIN3 + were compared.In total, 1851 participants had cervical histological outcomes and were included in the analysis. The sensitivity/specificity of the LBC test results with atypical squamous cells of undetermined significance or worse (LBC ≥ ASCUS) and the PAX1m/JAM3m test were 90.1%/26.7% and 84.8%/88.5%, respectively. PAX1m/JAM3m( +) had the highest diagnostic AUC (0.866, 95% confidence interval (CI) 0.837-0.896) in the whole cohort. All cancers (n = 20) were detected by PAX1m/JAM3m(+). Compared with LBC ≥ ASCUS, PAX1m/JAM3m(+) reduced the number of patients who needed referral for colposcopy by 57.21% (74.66% vs. 17.45%). The odds ratios for detecting CIN3 + by LBC ≥ ASCUS and PAX1m/JAM3m(+) were 3.3 (95% CI 2.0-5.9) and 42.6 (27.1-69.6), respectively (p < 0.001). The combination of LBC ≥ ASCUS or PAX1m/JAM3m(+) slightly increased the diagnostic sensitivity (98.0%, 95% CI: 95.8-100%) and referral rate (77.09%) but reduced the diagnostic specificity (24.8%, 22.7-26.8%).In non-16/18 hrHPV(+) women, PAX1m/JAM3m was superior to cytology for detecting CIN3 + . Compared with LBC ≥ ASCUS, PAX1m/JAM3m(+) reduced the number of significant referrals to colposcopy without compromising diagnostic sensitivity.© 2024. The Author(s).