人乳头瘤病毒核酸检测能力一致性评价研究  

Study on the Consistency Evaluation of Human Papillomavirus Nucleic Acid Detection Proficiency

作　　者：田亚宾[1] 蒋德云 任珊珊 刘雅丹[1] 李丽莉[1] 许四宏[1] Tian Yabin;Jiang Deyun;Ren Shanshan;Liu Yadan;Li Lili;Xu Sihong(National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Resaerch and Evaluation of Medical Devices,NMPA Key Laboratory for Quality Resaerch and Evaluation of In Vitro Diagnostics,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院体外诊断试剂检定所,国家药品监督管理局医疗器械质量研究与评价重点实验室,国家药品监督管理局体外诊断试剂质量研究与评价重点实验室,北京100050

出　　处：《中国药事》2025年第4期430-438,共9页Chinese Pharmaceutical Affairs

摘　　要：目的:开展人乳头瘤病毒(HPV)核酸检测能力一致性评价研究,评价国内不同实验室HPV核酸检测能力,促进国内实验室HPV核酸检测结果互认。方法:制备包含14种不同高危型别(HPV16、18、31、33、35、39、45、51、52、56、58、59、66、68)和2种低危型别(HPV6、11),既具有型别特异性,又兼具有量值准确性的HPV能力验证样本盘,经均匀性、稳定性验证后,以盲样形式发放至不同实验室进行检测并反馈检验结果。以总积分分级评价方式对能力验证结果进行评价。结果:共有27家实验室参加本次能力验证,其中22家实验室的检测结果为“满意”,5家实验室检测结果为“不满意”,满意率为81.5%。结论:不同实验室HPV核酸检测能力差异较大,部分实验室的检出能力较差。建议分析原因,从人员、设备、试剂盒和质量控制等4个方面加强实验室培训并及时整改,以提升自身实验室检测能力。Objective:To carry out the research on the consistency evaluation of human papillomavirus(HPV)nucleic acid detection ability,evaluate the HPV nucleic acid detection proficiency of different domesticlaboratories,so as to promote the mutual recognition of HPV nucleic acid detection results in domesticlaboratories.Methods:HPV samples containing 14 different high-risk types(HPV-16,-18,-31,-33,-35,-39,-45,-51,-52,-56,-58,-59,-66 and-68) and 2 low-risk types(HPV-6,-11) were prepared with both type specificityand quantitative accuracy.Then panel was sent to different laboratories in the form of blind samples for testing.The proficiency study results were evaluated by the method of total integral grading evaluation.Results:A totalof 27 laboratories participated in this proficiency study,of which 22 laboratories' test results were “satisfactory”and 5 laboratories' test results were “unsatisfactory”,with a satisfaction rate of 81.5%.Conclusion:The capacityof HPV test in different laboratories varies greatly,and the detection ability of some laboratories is poor.It isrecommended to analyze the causes,strengthen laboratory training and timely rectification from four aspects:personnel,equipment,kit and quality control,so as to improve their laboratory testing capabilities.

关 键 词：人乳头瘤病毒 核酸检测 能力验证 

分 类 号：R917[医药卫生—药物分析学] R95[医药卫生—药学]