资源匮乏地区人乳头瘤病毒DNA阳性女性分诊策略的准确性：一项在中国开展的横断面研究
Accuracy of triage strategies for human papillomavirus DNA-positive women in low-resource settings: A cross-sectional study in China.
作者信息
Wang Margaret, Hu Shangying, Zhao Shuang, Zhang Wenhua, Pan Qinjing, Zhang Xun, Chen Feng, Han Jinxiu, Ma Junfei, Smith Jennifer S, Qiao Youlin, Zhou Caihong, Zhao Fanghui
机构信息
Department of Cancer Epidemiology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
Pritzker School of Medicine, University of Chicago, Chicago, IL 60637-5415, USA.
出版信息
Chin J Cancer Res. 2017 Dec;29(6):496-509. doi: 10.21147/j.issn.1000-9604.2017.06.04.
OBJECTIVE
HPV is a human papillomavirus (HPV) DNA test for low-resource settings (LRS). This study assesses optimum triage strategies for HPV-positive women in LRS.
METHODS
A total of 2,530 Chinese women were concurrently screened for cervical cancer with visual inspection with acetic acid (VIA), liquid-based cytology and HPV testing by physician- and self-collected HPV, and physician-collected Hybrid Capture 2 (HC2). Screen-positive women were referred to colposcopy with biopsy and endocervical curettage as necessary. HPV-positivity was defined as ≥1.0 relative light units/cutoff (RLU/CO) for both HPV and HC2. Primary physician-HC2, physician-HPV and self-HPV and in sequential screening with cytology, VIA, or increased HPV test-positivity performance, stratified by age, were assessed for cervical intraepithelial neoplasia (CIN) grade 2/3 or worse (CIN2/3+) detection.
RESULTS
The sensitivities and specificities of primary HPV testing for CIN2+ were: 83.8%, 88.1% for physician-HPV; 72.1%, 88.2% for self-HPV; and 97.1%, 86.0% for HC2. Physician-HPV test-positive women with VIA triage had a sensitivity of 30.9% for CIN2+ versus 80.9% with cytology triage. Self-HPV test-positive women with VIA triage was 26.5% versus 66.2% with cytology triage. The sensitivity of HC2 test-positive women with VIA triage was 38.2% versus 92.6% with cytology triage. The sensitivity of physician-HPV testing for CIN2+ decreased from 83.8% at ≥1.0 RLU/CO to 72.1% at ≥10.00 RLU/CO, while the sensitivity of self-HPV testing decreased from 72.1% at ≥1.0 RLU/CO to 32.4% at ≥10.00 RLU/CO; similar trends were seen with age-stratification.
CONCLUSIONS
VIA and cytology triage improved specificity for CIN2/3 than no triage. Sensitivity with VIA triage was unsuitable for a mass-screening program. VIA provider training might improve this strategy. Cytology triage could be feasible where a high-quality cytology program exists. Triage of HPV test-positive women by increased test positivity cutoff adds another LRS triage option.
目的
HPV是一种针对资源匮乏地区（LRS）的人乳头瘤病毒（HPV）DNA检测。本研究评估了资源匮乏地区HPV检测呈阳性女性的最佳分流策略。
方法
共有2530名中国女性同时接受了醋酸肉眼观察法（VIA）、液基细胞学检查以及由医生采集和自我采集的HPV检测，还有医生采集的杂交捕获2代（HC2）检测，以进行宫颈癌筛查。筛查呈阳性的女性被转诊至阴道镜检查，并根据需要进行活检和宫颈管刮除术。HPV阳性定义为HPV和HC2的相对光单位/临界值（RLU/CO）均≥1.0。评估了初次医生-HC2、医生-HPV和自我-HPV以及在与细胞学检查、VIA或增加的HPV检测阳性性能进行序贯筛查时，按年龄分层的宫颈上皮内瘤变（CIN）2/3级或更高级别（CIN2/3+）的检测情况。
结果
初次HPV检测对CIN2+的敏感性和特异性分别为：医生-HPV检测为83.8%、88.1%；自我-HPV检测为72.1%、88.2%；HC2检测为97.1%、86.0%。VIA分流的医生-HPV检测呈阳性的女性对CIN2+ 的敏感性为30.9%，而细胞学分流时为80.9%。VIA分流的自我-HPV检测呈阳性的女性对CIN2+ 的敏感性为26.5%，而细胞学分流时为66.2%。VIA分流的HC2检测呈阳性的女性对CIN2+ 的敏感性为38.2%，而细胞学分流时为92.6%。医生-HPV检测对CIN2+ 的敏感性从RLU/CO≥1.0时的83.8%降至RLU/CO≥10.00时的72.1%，而自我-HPV检测的敏感性从RLU/CO≥1.0时的72.1%降至RLU/CO≥10.00时的32.4%；年龄分层时也观察到类似趋势。
结论
与不进行分流相比，VIA和细胞学分流提高了CIN2/3的特异性。VIA分流的敏感性不适用于大规模筛查项目。对VIA提供者进行培训可能会改善这一策略。在存在高质量细胞学检查项目的地方，细胞学分流可能是可行的。通过提高检测阳性临界值对HPV检测呈阳性的女性进行分流增加了另一种资源匮乏地区的分流选择。
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