PAX1M/JAM3M的分类性能在非第16/16/16人乳头瘤病毒阳性女性的宫颈癌筛查中：中国的多中心前瞻性研究
Triage performance of PAX1m/JAM3m in opportunistic cervical cancer screening of non‒16/18 human papillomavirus-positive women: a multicenter prospective study in China
影响因子:4.40000
分区:医学2区 / 遗传学2区 肿瘤学2区
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
摘要
在这项研究中，我们旨在验证PAX1和JAM3甲基化（PAX1M/JAM3M）测试作为分类工具，用于检测在非16/18高风险的人毛皮症患者（非16/18）中上皮内肿瘤3级或更差的（CIN3+），非16/18 hrhpia tria tria tria tria tria。比较了（LBC）和PAX1M/JAM3M检测CIN3+的测试。总共有1851名参与者具有宫颈组织学结果，并包括在分析中。 LBC测试结果的敏感性/特异性分别具有不确定意义或更差的非典型鳞状细胞（LBC≥ASCUS）和PAX1M/JAM3M测试分别为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）。通过PAX1M/JAM3M（+）检测到所有癌症（n = 20）。与LBC≥ASCUS相比，PAX1M/JAM3M（+）将需要转录的患者数量减少了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（+）的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％）（77.09％）（77.09％），但降低了诊断特异性（24.8％，24.8％，22.7-26.8％）。检测CIN3+的细胞学。与LBC≥ASCUS相比，PAX1M/JAM3M（+）减少了对阴道镜检查的显着转诊数量，而不会损害诊断敏感性。
Abstract
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.