摘要
目的探讨人乳头瘤病毒(human papillomavirus,HPV)即时检测(point of care testing,POCT)方法在高危人群宫颈上皮内病变筛查中的临床适用性。方法对499例有阴道镜转诊指征患者,采用HPV POCT方法和一代测序技术分别进行HPV检测,并进行一致性比较,评价HPV POCT快检方法对HPV检测的准确性;结合患者的病理结果,分析其对高风险人群宫颈上皮内病变的临床预测性能。结果在499例患者中,HPV总阳性率为82.57%(412/499),HPV POCT结果与一代测序结果的总体符合率为90.49%(1094/1209)。以一代测序结果为参照,HPV POCT方法的灵敏度、特异性、准确度、阳性预测值、阴性预测值高于90.00%,Kappa一致性系数大于0.90(P<0.001)。HPV POCT方法对宫颈上皮内瘤变(cervical intraepithelial neoplasia,CIN)2+及CIN3的筛查的灵敏度、特异性等参数与一代测序技术相当。结论HPV POCT方法在HPV检测和宫颈高级别病变预测方面与一代测序技术具有较好的一致性。
Objective To investigate the clinical applicability of human papillomavirus(HPV)pointof-care testing(POCT)in screening cervical intraepithelial lesions in high-risk populations.Methods In 499 patients with colposcopic referral indication,HPV POCT method and Sanger sequencing were used for HPV detection,and the consistency of HPV POCT rapid detection method was compared to evaluate the accuracy of HPV detection.Combined with the pathological results of patients,the clinical prediction performance of cervical intraepithelial lesions in high-risk population was analyzed.Results Among 499 patients,the overall HPV infection rate was 82.57%(412/499).The overall coincidence rate between HPV POCT method and Sanger sequencing technology was 90.49%(1094/1209).Taking Sanger sequencing detection results as a reference,the sensitivity,specificity,accuracy,positive predictive value and negative predictive value of HPV POCT method were higher than 90.00%,and the Kappa consistency coefficient was greater than 0.90(P<0.001).The sensitivity and specificity of HPV POCT for screening of cervical intraepithelial neoplasia(CIN)2+and CIN 3 is comparable to that of Sanger sequencing.Conclusions HPV POCT method demonstrated high consistency with Sanger sequencing in terms of HPV detection and CIN 2+prediction.
作者
赵超
李明珠
安佳慧
李静然
赵昀
谢群慧
魏丽惠
ZHAO Chao;LI Mingzhu;AN Jiahui;LI Jingran;ZHAO Yun;XIE Qunhui;WEI Lihui(Department of Obstetrics and Gynecology,Peking University People’s Hospital,Beijing,100044,China;State Key Laboratory of Environmental Chemistry and Ecotoxicology,Research Center for Eco-Environmental Sciences,Chinese Academy of Sciences,Beijing,100085,China;University of Chinese Academy of Sciences,Beijing,100049,China)
出处
《中国妇产科临床杂志》
CSCD
北大核心
2024年第4期303-307,共5页
Chinese Journal of Clinical Obstetrics and Gynecology
基金
国家重点研发计划(2021YFC2701202)
北京市卫生健康科技成果和适宜技术推广项目(BHTPP2022008)
北京大学人民医院横向科研课题(2022-Z-25)。
关键词
人乳头状瘤病毒
即时检测
宫颈上皮内瘤变
高危人群
human papillomavirus
instant detection
cervical intraepithelial neoplasia
high risk population
