阴道镜前阶段的主要筛查异常是测试结果意味着直接转诊阴道镜检查（和/或加急治疗），而无需进行额外的高级鳞状上皮内病变或更严重（HSIL）风险选择测试。目前，正在对两种经过临床验证的 HSIL 风险选择测试（反射细胞学和反射 p16/Ki67 双染色 (DS)）进行比较，以用于基于人乳头瘤病毒 (HPV) 的原发性筛查，以避免可能的过度治疗，但仍没有足够的数据可用于他们的表现。在 30 066 份液基宫颈癌筛查结果中，选择了 332 名女性，其中包括 16/18 有限基因分型、液基细胞学、DS 和标准化阴道镜组织学结果的可用高危类型 HPV 检测结果。活检。在 HPV 16/18 病例中，对三种分诊方法进行了回顾性分析。计算了 HSIL 检测的预测值以及每种策略所需的阴道镜检查次数。两种使用 DS 的分诊模型（在所有情况下均先进行反射细胞学检查，然后仅进行反射 DS）对 HSIL 的阳性预测值显着高于仅使用反射细胞学检查的策略（44.2%/45.7% vs. 28.3%；p < 0.0001） 。在 DS 模型中，需要较少的阴道镜检查（95/92 vs. 152），并且每次 HSIL 检测所需的阴道镜检查次数也较少（2.26/2.19 vs. 3.54）。在采用 DS 的两种分诊模型中，仅漏掉了 1 例 HSIL 病例。 p16/Ki67 双重染色可能是一种有效的单独或与细胞学、分类测试相结合的方法，用于检测基于 HPV 的初级宫颈癌筛查中存在主要筛查异常的患者的 HSIL。将细胞学检查作为首次分诊测试可以在选定的病例中转诊至加急治疗，从而改进策略。© 2024 Wiley periodicals LLC。

Major screening abnormalities in precolposcopic stage are tests results that imply direct referral to colposcopy (and/or expedited treatment) without performing additional high-grade squamous intraepithelial lesions or worse (HSIL+) risk selection testing. Currently, both clinically validated HSIL+ risk selection tests, reflex cytology and reflex p16/Ki67 dual staining (DS), are being compared for use in primary human papillomavirus (HPV)-based screening to avoid possible overtreatment, but there is still no sufficient data available for their performance. Among 30 066 liquid-based cervical cancer screening tests results, a group of 332 women was selected with available high-risk types of HPV tests results with 16/18 limited genotyping, liquid-based cytology, DS, and histology results from standardized colposcopy with biopsy. In HPV 16/18+ cases, three triage approaches were retrospectively analyzed. Predictive values for detection of HSIL+ were calculated and number of colposcopies required in each strategy. Both triage models with DS used (reflex cytology followed by DS, and reflex DS alone in all cases) had significantly higher positive predictive value for HSIL+ than strategy with reflex cytology alone (44.2%/45.7% vs. 28.3%; p < 0.0001). In models with DS, less colposcopies were required (95/92 vs. 152) and less colposcopies were needed per HSIL+ detection (2.26/2.19 vs. 3.54). Only one HSIL+ case was missed in both triage models with DS incorporation. p16/Ki67 dual-stain may be an effective, alone or combined with cytology, triage test to detect HSIL+ in patients with major screening abnormalities in primary HPV-based cervical cancer screening. Performing cytology as the first triage test improves the strategy by enabling referrals to expedited treatment in selected cases.© 2024 Wiley Periodicals LLC.