背景：高危型人乳头瘤病毒（hrHPV）筛查的实施大大降低了宫颈癌的发病率和死亡率。然而,一种有效的分诊策略，非侵入性，独立于病理学家的主观解释，迫切需要减少hrHPV阳性女性不必要的阴道镜转诊。
方法：将来自国际和平妇幼保健院的3251名年龄在30-82岁（中位数=41岁）的hrHPV阳性女性纳入培训集（n=2116）和验证集（n=1135），以建立宫颈癌甲基化（CerMe）检测。评估了CerMe作为hrHPV阳性女性的分诊表现。
结果：CerMe检测可有效区分宫颈上皮内瘤变2级或更差（CIN2）与宫颈上皮内瘤变1级或正常（CIN1-）女性，其敏感性为82.4％（95％CI=72.6〜89.8％），特异性为91.1％（95％CI=89.2〜92.7％）。重要的是,CerMe显示特异性提高（92.1％vs.74.9％）在其他12hrHPV型阳性女性中，以及较高的敏感性（80.8％与61.5%）和特异性（88.9%vs.与细胞学检测相比，HPV16/18型阳性女性为75.3％）。CerMe在患有ASC-US的hrHPV阳性女性的分诊中表现良好（敏感性=74.4%，特异性=87.5%)或LSIL细胞学(灵敏度=84.4%，特异性=83.9%)。
结论：基于PCDHGB7高甲基化的CerMe检测可作为hrHPV阳性女性的分诊策略，以减少不必要的过度转诊。
背景：ChiCTR2100048972。2021年7月19日注册
Implementation of high-risk human papillomavirus (hrHPV) screening has greatly reduced the incidence and mortality of cervical cancer. However, a triage strategy that is effective, noninvasive, and independent from the subjective interpretation of pathologists is urgently required to decrease unnecessary colposcopy referrals in hrHPV-positive women.
A total of 3251 hrHPV-positive women aged 30-82 years (median = 41 years) from International Peace Maternity and Child Health Hospital were included in the training set (n = 2116) and the validation set (n = 1135) to establish Cervical cancer Methylation (CerMe) detection. The performance of CerMe as a triage for hrHPV-positive women was evaluated.
CerMe detection efficiently distinguished cervical intraepithelial neoplasia grade 2 or worse (CIN2 +) from cervical intraepithelial neoplasia grade 1 or normal (CIN1 -) women with excellent sensitivity of 82.4% (95% CI = 72.6 ~ 89.8%) and specificity of 91.1% (95% CI = 89.2 ~ 92.7%). Importantly, CerMe showed improved specificity (92.1% vs. 74.9%) in other 12 hrHPV type-positive women as well as superior sensitivity (80.8% vs. 61.5%) and specificity (88.9% vs. 75.3%) in HPV16/18 type-positive women compared with cytology testing. CerMe performed well in the triage of hrHPV-positive women with ASC-US (sensitivity = 74.4%, specificity = 87.5%) or LSIL cytology (sensitivity = 84.4%, specificity = 83.9%).
PCDHGB7 hypermethylation-based CerMe detection can be used as a triage strategy for hrHPV-positive women to reduce unnecessary over-referrals.
ChiCTR2100048972. Registered on 19 July 2021.
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