人乳头瘤病毒L1基因分型国家参考品的升级换代研制  

Upgrading of national reference materials for the L1 region of Human Papillomavirus genotyping

作　　者：田亚宾[1,2,3] 赵娟 沈舒 刘东来[1,2,3] 周海卫 许四宏[1,2,3] TIAN Yabin;ZHAO Juan;SHEN Shu;LIU Donglai;ZHOU Haiwei;XU Sihong(Division Ⅱ of In Vitro Diagnostics for Infectious Diseases,National Institutes for Food and Drug Control,Beijing,China,100050;NMPA Key Laboratory for Quality Research and Evaluation of Medical Devices,Beijing,China,100050;NMPA Key Laboratory for Quality Research and Evaluation of In Vitro Diagnostics,Beijing,China,100050;General Administration Of Customs(Beijing)International Travel Healthcare Center,Beijing,China,100013)

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传染病诊断试剂二室,北京100050 [2]国家药品监督管理局医疗器械质量研究与国家重点实验室,北京100050 [3]国家药品监督管理局体外诊断试剂质量研究与国家重点实验室,北京100050 [4]海关总署(北京)国际旅行卫生保健中心,北京100013

出　　处：《分子诊断与治疗杂志》2024年第7期1386-1389,1394,共5页Journal of Molecular Diagnostics and Therapy

摘　　要：目的 对人乳头瘤病毒(HPV)L1基因分型国家参考品升级换代,以提高基于L1检测靶区的HPV核酸(分型)试剂的质量。方法 研制包含了34种不同型别HPV L1的质粒样品。经商业化核酸检测试剂复核验证,分装组成国家参考品。采用荧光PCR法进行量值标定,并溯源至WHO第一代HPV16 DNA国际参考品。结合不同实验室的协作标定研究和适用性验证结果,确定参考品的质量标准,并进一步考察参考品的稳定性。结果 国家参考品包括34种不同型别HPV样本和5种HPV阴性病原体,型别上囊括了HPV68a和HPV68b亚型。34种不同型别HPV DNA含量为6.26~7.08 Log10 IU/mL,并要求各试剂准确性应能检出其检测范围内的所有型别且分型正确,其检出限应不高于104 IU/反应。结论 成功建立了新一代HPV L1基因分型国家参考品,用于评价L1检测靶区的HPV核酸检测试剂的质量。Objective To upgrade national reference materials for human papillomavirus(HPV)L1 genotyping,to improve the quality of HPV tests based on the L1 region.Methods Samples of 34 different HPV genotypes based on L1 fragment plasmids were developed and obtained.After being verified by commercial HPV assays,all samples were divided into a national reference standard.These samples of 34 different genotypes were then calibrated against the 1st WHO IS for HPV Type 16 DNA using real-time PCR.A collaborative study was performed to assess the reliability of the references and determine any requirements.Meanwhile,the stability of the National Reference Panel was evaluated.Results National reference materials consist of 34 different types of HPV samples and five HPV-negative pathogens,including the HPV68a and HPV68b subtypes.The DNA content of the 34 different types of HPV ranged from 6.26~7.08 Log10 IU/mL.The accuracy of each reagent should be capable of detecting all types within the detection range,ensuring correct,typing,and maintaining a detection limit not exceeding 104IU/reaction.Conclusion The next-generation National Reference Panel for the L1 region of Human Papillomavirus genotyping has been successfully established.It is intended to assess the performance of HPV NAT.

关 键 词：人乳头瘤病毒 核酸检测试剂 L1基因 国家参考品 

分 类 号：R927.1[医药卫生—药学]