Objective: This study aimed to evaluate the clinical performance of p16/Ki-67 dual staining for triage high risk HPV (HR-HPV) infected women. Method: Target objects were women who infected HR-HPV and received colposcopy examination between April and December of 2016 at the Second Affiliated Hospital of Zhengzhou University. Gynecologists collected the cervical exfoliated cells from eligible women for p16/Ki-67 dual staining, LBC testing and HPV DNA testing. Histology diagnosis were used as gold standard. Sensitivities, specificities, positive predictive values (PPVs), negative predictive values (NPVs) of p16/Ki-67 dual staining, LBC testing and HPV16/18 testing for triage of HR-HPV positive population were calculated and compared. Results: A total of 295 HR-HPV infected women were selected, and the mean age was (44.29±11.48) years old. Positive rates of p16/Ki-67 dual staining, HPV16/18 testing and LBC testing were 70.17% (207), 56.95% (168) and 85.76% (253), respectively. When CIN2+as the endpoint, among the three triage methods, sensitivity of p16/Ki-67 dual staining was 90.00% (95%CI: 85.06%-93.43%), higher than the value of HPV 16/18 testing, but lower than the value of LBC testing. Specificity, PPV and NPV of p16/Ki-67 dual staining were the highest [71.58% (95%CI: 61.81%-79.67%), 86.96% (95%CI:81.69%-90.88%) and 77.27% (95%CI: 67.49%-84.78%)]. When detection for CIN3+, sensitivity of p16/Ki-67 dual staining was 92.90% (95%CI: 87.74%-95.99%), lower than the value of LBC testing, but higher than the value of HPV16/18 testing. Specificity of p16/Ki-67 dual staining was 55.00% (95%CI: 46.74%-63.00%), lower than the value of HPV16/18 testing, but higher than the value of LBC testing. PPV of p16/Ki-67 dual staining was 69.57% (95%CI: 62.99%-75.43%), lower than the value of HPV 16/18 testing, but higher than the value of LBC testing. NPV of p16/Ki-67 dual staining was 87.50% (95%CI: 78.99%-92.87%), higher than value of HPV 16/18 testing, but lower than the value of LBC testing. Conclusion: p16/Ki-67 dual staining has better clinical effects than HPV 16/18 testing and LBC testing for triage women with HR-HPV infection.
目的： 评估p16/Ki-67双染检测在高危（HR）人乳头瘤病毒（HPV）阳性人群中的分流效果。 方法： 于2016年4—12月，选取在郑州大学第二附属医院妇科就诊，并进行阴道镜检查且HPV DNA检测结果为HR-HPV感染的女性为调查对象，收集其宫颈脱落细胞标本，并分别进行p16/Ki-67双染检测、HPV16/18检测、LBC检测和活检病理诊断。以活检病理结果为结局指标，计算和比较3种检测分流HR-HPV阳性者的灵敏度、特异度、阳性预测值和阴性预测值。 结果： 共发现HR-HPV阳性女性295例，年龄为（44.29±11.48）岁，其中p16/Ki-67双染检测、HPV16/18检测和LBC检测的阳性率分别为70.17%（207例）、56.95%（168例）和85.76%（253例）。以CIN2+为疾病终点指标时，3种检测方法中，p16/Ki-67双染检测的灵敏度为90.00%（95%CI：85.06%~93.43%），高于HPV16/18检测，低于LBC检测；特异度最高，为71.58%（95%CI:61.81%~79.67%）；阳性预测值最高，为86.96%（95%CI:81.69%~90.88%）；阴性预测值最高，为77.27%（95%CI:67.49%~84.78%）。以CIN3+为疾病终点指标时，p16/Ki-67双染检测的灵敏度为92.90%（95%CI:87.74%~95.99%），低于LBC检测，高于HPV16/18检测；特异度为55.00%（95%CI: 46.74%~63.00%），低于HPV16/18检测，高于LBC检测；阳性预测值为69.57%（95%CI:62.99%~75.43%），低于HPV16/18检测，高于LBC检测；阴性预测值为87.50%（95%CI:78.99%~92.87%），高于HPV16/18检测，低于LBC检测。 结论： p16/Ki-67双染检测技术作为HPV阳性妇女分流措施的效果优于HPV16/18检测和LBC检测方法。.
Keywords: Cervical intraepithelial neoplasia; Ervix Uteri; Experiment study; HR-HPV positive; p16/Ki-67 dual staining.