Objective: To evaluate the performance of high risk human papillomavirus (HR-HPV) DNA test for triage ASC-US in Chinese population. Methods: The study population was from Jiyuan city in Henan Province where a cervical cancer screening cohort (4 026 women) was set up from April to July in 2017. Women with ASC-US and complete recall information of colposcope were selected as the study objects. Self-designed questionnaire was used to survey the general information and medical history of cervical cancer, thencervical cytological speciments were collected for cytodiagnosis and HPV DNA test, followed by colposcopy, lesion biopsy and histology diagnose. The diagnosis of histology was used as the gold standard. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) as well as corresponding 95% confidential interval (CI) were calculated. Results: The average age of the included 393 women with ASC-US were (50.81±9.22) years old. The positivity of high risk human papillomavirus (HR-HPV), HPV16 and HPV18 were 35.6%, 10.69% and 2.80%, respectively. The sensitivity, specificity, PPV and NPV for HR-HPV to detect CIN2+ were 84.38% (68.25%-93.14%), 68.70% (63.74%-73.26%), 19.29% (13.61%-26.61%) and 98.02% (95.46%-99.15%). When compared with HR-HPV, HPV16/18 had a lower sensitivity (59.38% (42.26%-74.48%)) and a higher specificity(91.14% (87.75%-93.65%)), the PPV and NPV were 59.38% (25.32%-50.98%) and 91.14% (93.61%-97.77%). Conclusion: It was more effective for HR-HPV to triage ASC-US than HPV16/18. In order to improve the effect of HPV16/18, it should include more HR-HPV types which were more prevalent in Chinese population.
目的：评价高危型HPV（HR-HPV）DNA检测在未明确意义的非典型鳞状上皮细胞（ASC-US）分流中的效果。 方法：研究对象来源于2017年4—5月在河南省济源市建立的宫颈癌筛查队列，选取其中有完整阴道镜召回信息及细胞学诊断为ASC-US的女性作为研究对象，共393名。采用自制问卷收集研究对象一般情况和宫颈癌病史等信息，采集其宫颈脱落细胞标本进行HPV DNA检测，同时进行阴道镜检查，病变处取活检行组织病理学诊断。将病理学诊断作为金标准，计算HPV DNA检测的灵敏度、特异度、阳性预测值（PPV）、阴性预测值（NPV）及其95%CI值。 结果： 393名研究对象的年龄为（50.81±9.22）岁，其中HR-HPV、HPV16/18的阳性率分别为35.62%、10.69%和2.80%。将宫颈上皮内瘤样病变（CIN）2级及以上（CIN2+）作为疾病终点时，HR-HPV分流ASC-US人群的灵敏度、特异度、PPV、NPV分别为84.38%（68.25%~93.14%）、68.70%（63.74%~73.26%）、19.29%（13.61%~26.61%）、98.02%（95.46%~99.15%）；HPV16/18分流的灵敏度为59.38%（42.26%~74.48%），特异度为91.14%（87.75%~93.65%），PPV和NPV分别为59.38%（25.32%~50.98%）和91.14%（93.61%~97.77%）。 结论： HR-HPV作为ASC-US人群分流措施的效果优于HPV16/18，可以通过增加特异性的HR-HPV型别来提高HPV16/18的分流效果。.
Keywords: Atypical squamous cells of undetermined signification; Cervical intraepithelial neoplasia; Human papillomavirus; Triage.