Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, P. O. Box 2014, 1014 Copenhagen, Denmark.
Department of Pathology, Copenhagen University Hospital, Hvidovre, Kettegård Allé 30, 2650 Hvidovre, Denmark; Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Kettegård Allé 30, 2650 Hvidovre, Denmark.
Eur J Cancer. 2015 Jul;51(11):1456-66. doi: 10.1016/j.ejca.2015.04.012. Epub 2015 May 12.
We compared cytology with Hybrid Capture 2 (HC2), cobas, CLART and APTIMA Human Papillomavirus (HPV) assays in primary cervical screening at age 23-29 years based on data from the Danish Horizon study. SurePath samples were collected from 1278 women undergoing routine cytology-based screening. Abnormal cytology was managed according to the routine recommendations, and women with cytology-normal/HPV-positive samples were invited for repeated cytology and HPV testing in 1.5 years. Loss to follow-up was similar between HPV assays. ⩾ CIN3 was detected in 44 women. The sensitivity of HC2 for ⩾ CIN3 was 95% (95% confidence interval (CI): 85-99), of cobas 98% (95% CI: 88-100), of CLART 100% (95% CI: 92-100), of APTIMA 82% (95% CI: 67-92), and of cytology 59% (95% CI: 43-74). Specificity for ⩾ CIN3 varied between 61% (95% CI: 59-64) for cobas and 75% (95% CI: 73-78) for APTIMA, and was 94% (95% CI: 93-96) for cytology. Similar results were observed for ⩾ CIN2 (N = 68). HPV screening with cytological triage doubled the number of colposcopies compared to cytology screening, and increased the frequency of repeated testing by four (APTIMA) to seven (cobas) times. The positive predictive value of a referral for colposcopy was relatively high for all screening tests (⩾ 30% for ⩾ CIN3, and ⩾ 50% for ⩾ CIN2). CIN1 was detected by cytology in ∼ 1% of women, and in ∼ 2% by any of the four HPV assays. Although highly sensitive, HPV-based screening of young Danish women should be approached cautiously, as it resulted in large reductions in specificity, and increased the demand for additional testing.
我们基于丹麦 Horizon 研究的数据，比较了细胞学、杂交捕获 2 （HC2）、 cobas、CLART 和 APTIMA 人乳头瘤病毒（HPV）检测在 23-29 岁女性初级宫颈筛查中的应用。SurePath 样本采集自 1278 例行常规细胞学筛查的女性。异常细胞学根据常规建议进行管理，细胞学正常/HPV 阳性的女性被邀请在 1.5 年内重复进行细胞学和 HPV 检测。各 HPV 检测的失访率相似。共检出 44 例 ⩾ CIN3。HC2 对 ⩾ CIN3 的敏感性为 95%（95%置信区间（CI）：85-99）， cobas 为 98%（95% CI：88-100），CLART 为 100%（95% CI：92-100），APTIMA 为 82%（95% CI：67-92），细胞学为 59%（95% CI：43-74）。 ⩾ CIN3 的特异性在 cobas 之间为 61%（95% CI：59-64），在 APTIMA 之间为 75%（95% CI：73-78），在细胞学之间为 94%（95% CI：93-96）。 ⩾ CIN2（N = 68）的结果相似。细胞学筛查联合 HPV 筛查使阴道镜检查的数量增加了一倍，并且使重复检测的频率增加了四倍（APTIMA）至七倍（cobas）。所有筛查试验的转诊行阴道镜检查的阳性预测值都相对较高（ ⩾ CIN3 为 30%以上， ⩾ CIN2 为 50%以上）。细胞学检测发现约 1%的女性有 CIN1，而四种 HPV 检测中有约 2%的女性有 CIN1。尽管 HPV 检测具有较高的敏感性，但应谨慎对待年轻丹麦女性的 HPV 筛查，因为它导致特异性大幅降低，并增加了对额外检测的需求。
