人乳头瘤病毒 (HPV) 检测是推荐的宫颈癌主要筛查方法。丹麦于 2021 年开始实施 HPV 检测作为主要筛查方法，但尚未提供全国数据。我们报告了丹麦大型试点实施研究中第一轮和第二轮筛选的结果。目的是比较阴道镜转诊，识别高级别宫颈上皮内瘤变 (CIN) 和癌症，以及基于 HPV 和基于细胞学的筛查之间的阳性预测值 (PPV)。 在 HPV SCREEN DENMARK 队列（2017 年 5 月至 12 月建立）中2019 年），参与者根据居住城市被分配到基于 HPV 的筛查（n = 28,677）或基于细胞学的筛查（n = 43,622）。第一轮筛查显示 HPV 组的阴道镜检查转诊率更高（6.4%）。细胞学检查 (2.3 %)，HPV 筛查检测到的 CIN3 (n = 306/28,677 (1.1 %)) 多于细胞学检查 (n = 241/43,622 (0.6 %)) (RR = 1.9 (95 % CI 1.6-2.3))。从绝对数量来看，每 1000 名接受筛查的女性中，另外 41 次阴道镜检查转诊导致额外检测出 10 例 CIN2 病例和 5 例额外 CIN3 病例。HPV 组中通过常规筛查启动的阴道镜检查中 CIN3 的 PPV 相似 (24.1%)，而细胞学组（25.7%）在筛查的最初几年内，与细胞学组相比，HPV 组的 CIN3 和宫颈癌的累积发病率增加得更快。基于 HPV 的宫颈筛查检测到的 CIN3 病例几乎是细胞学组的两倍，但其代价是阴道镜检查转诊次数增加了两倍多。此外，我们发现基于 HPV 的筛查比基于细胞学的筛查更早发现宫颈癌。版权所有 © 2024。由 Elsevier Inc. 出版。

Human papillomavirus (HPV) testing is the recommended primary screening method against cervical cancer. Denmark started implementing HPV testing as a primary screening method in 2021, but no national data are yet available. We report the results of the first and second screening rounds in a large Danish pilot implementation study. The objective was to compare colposcopy referrals, identify high-grade cervical intraepithelial neoplasia (CIN) and cancer, and positive predictive value (PPV) between HPV-based and cytology-based screening.In the HPV SCREEN DENMARK cohort (established May 2017-December 2019), participants were assigned to HPV-based (n = 28,677) or cytology-based screening (n = 43,622) based on the municipality of residence.The first round of screening showed higher colposcopy referrals in the HPV group (6.4 %) compared to cytology (2.3 %), with HPV screening detecting more CIN3+ (n = 306/28,677 (1.1 %)) than cytology (n = 241/43,622 (0.6 %)) (RR = 1.9 (95 %CI 1.6-2.3). In absolute terms, 41 additional colposcopy referrals resulted in the detection of 10 more cases of CIN2+ and five extra CIN3+ cases per 1000 women screened. The PPV for CIN3+ of a colposcopy initiated by routine screening was similar in the HPV group (24.1 %) and cytology group (25.7 %). Within the initial years of screening, the cumulative incidence of CIN3+ and cervical cancer showed a more rapid increase in the HPV group compared to the cytology group.HPV-based cervical screening detects almost twice as many CIN3+ cases but at the expense of a more than two-fold increase in colposcopy referrals. Furthermore, we found that HPV-based screening detects cervical cancer earlier than cytology-based screening.Copyright © 2024. Published by Elsevier Inc.