Ruan Guanyu, Song Yiyi, Dong Binhua, Mao Xiaodan, Lin Fen, Kang Yafang, Xu Shuxia, Chen Xianjing, Wu Qibin, Sun Pengming
Laboratory of Gynecologic Oncology, Fujian Provincial Maternity and Children's Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China,
Department of Gynecology, Fujian Provincial Maternity and Children's Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China,
Cancer Manag Res. 2018 Sep 4;10:3227-3235. doi: 10.2147/CMAR.S169822. eCollection 2018.
The Cervista high-risk human papillomavirus (HR-HPV) test was evaluated as a primary screening method for cervical cancer in women aged ≥21 years and was compared with different screening and triage combinations.
A nested case-control study within the Fujian provincial Cervical Lesion Screening Cohorts was used to evaluate the Cervista test as the primary cervical screening method in a hospital-based population. Strategy 1 primarily screened using a cytology screen with HR-HPV testing used for triage. Strategy 2 primarily screened using cytology and HR-HPV co-testing. Strategy 3 primarily screened using HR-HPV testing and triaged HPV-positive women based on cytology. Strategy 4 primarily screened using HR-HPV testing and referred A9 pool HPV-positive women to colposcopy directly, whereas non-A9 HPV-positive women were triaged using cytology.
There were 10,183 women included in this study; 16.49% (1677/10,183) were HR-HPV-positive, 9.52% had abnormal cytology, and 9907 women were normal during followup. A total of 276 women were diagnosed with cervical intraepithelial neoplasia 2 or worse (CIN2+), 197 with CIN3 or worse (CIN3+), and 70 with cervical cancer. Moreover, 10.15% (20/197) women who were CIN3+ were identified as cytology-negative, while 8.63% (17/197) were HR-HPV negative (>0.05). The cumulative risk rate for HPV-/cytology- was 0.836 (95% CI, 0.424-1.648) in CIN3+ cases. Strategy 4 yielded the highest sensitivity for CIN2+ or CIN3+ and the lowest positive predictive value for CIN2+ or CIN3+ among the four screening strategies.
The Cervista HR-HPV test can provide a reliable and sensitive clinical reference for the cervical cancer primary screen.
评估Cervista高危型人乳头瘤病毒（HR-HPV）检测作为≥21岁女性宫颈癌的主要筛查方法，并与不同的筛查和分流组合进行比较。
在福建省宫颈病变筛查队列中进行巢式病例对照研究，以评估Cervista检测作为基于医院人群的主要宫颈筛查方法。策略1主要采用细胞学筛查，并用HR-HPV检测进行分流。策略2主要采用细胞学和HR-HPV联合检测。策略3主要采用HR-HPV检测，并根据细胞学结果对HPV阳性女性进行分流。策略4主要采用HR-HPV检测，将A9型池HPV阳性女性直接转诊至阴道镜检查，而非A9型HPV阳性女性则采用细胞学进行分流。
本研究纳入10183名女性；16.49%（1677/10183）为HR-HPV阳性，9.52%有细胞学异常，9907名女性在随访期间正常。共有276名女性被诊断为宫颈上皮内瘤变2级或更严重（CIN2+），197名患有CIN3或更严重（CIN3+），70名患有宫颈癌。此外，10.15%（20/197）的CIN3+女性被确定为细胞学阴性，而8.63%（17/197）为HR-HPV阴性（>0.05）。在CIN3+病例中，HPV-/细胞学-的累积风险率为0.836（95%CI，0.424-1.648）。在四种筛查策略中，策略4对CIN2+或CIN3+的敏感性最高，对CIN2+或CIN3+的阳性预测值最低。
Cervista HR-HPV检测可为宫颈癌初筛提供可靠且敏感的临床参考。
