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国际人乳头瘤病毒参考中心:HPV 研究和诊断中的标准化、协作和质量保证。

The International Human Papillomavirus Reference Center: Standardization, collaboration, and quality assurance in HPV research and diagnostics.

机构信息

Department of Clinical Science, Intervention and Technology (CLINTEC), Center for Cervical Cancer Elimination, Karolinska Institutet, Stockholm, Sweden.

Center for Cervical Cancer Elimination, Karolinska University Hospital Huddinge, Stockholm, Sweden.

出版信息

J Med Virol. 2023 Dec;95(12):e29332. doi: 10.1002/jmv.29332.

Abstract

The International Human Papillomavirus (HPV) Reference Center (IHRC) confirms and assigns type numbers to novel HPV types, maintains a reference clone repository, and issues international proficiency panels for HPV screening and genotyping. Furthermore, the Center coordinates the Global HPV Reference Laboratory Network that promotes collaboration and international exchange of experiences among national HPV reference laboratories, to further international standardization and quality assurance in the HPV field. The established HPV types (n = 225) belong to 5 different genera: alpha (n = 65), beta (n = 54), gamma (n = 102), mu (n = 3) and nu (n = 1). Since the last published IHRC overview in 2018, 6 novel types have been established, with 5/6 belonging to the gamma genus and 1/6 to beta genus. Also, 474 reference clones have been provided to 55 different research laboratories and the global proficiency program for HPV genotyping has seen an increasing proficiency (despite a decrease seen in 2019), from 68% proficiency in 2017 to 77.3% in 2022. The first proficiency study for HPV screening found an international proficiency of up to 77%. In summary, increasing complexity of the HPVs and demands on quality assurance in the era of cervical cancer elimination requires international efforts to support proficiency and recognized quality and order among HPV types.

摘要

国际人乳头瘤病毒(HPV)参考中心(IHRC)负责确认和分配新型 HPV 类型的编号,维护参考克隆库,并发布 HPV 筛查和基因分型国际能力验证小组。此外,该中心协调全球 HPV 参考实验室网络,促进各国 HPV 参考实验室之间的合作和经验交流,以进一步实现 HPV 领域的国际标准化和质量保证。已确定的 HPV 类型(n=225)属于 5 个不同属:α(n=65)、β(n=54)、γ(n=102)、μ(n=3)和ν(n=1)。自 2018 年发表上一次 IHRC 概述以来,已经确定了 6 种新型 HPV 类型,其中 5/6 属于γ属,1/6 属于β属。此外,已经向 55 个不同的研究实验室提供了 474 个参考克隆,HPV 基因分型全球能力验证计划的能力不断提高(尽管 2019 年有所下降),从 2017 年的 68%提高到 2022 年的 77.3%。第一项 HPV 筛查能力验证研究发现,国际 HPV 筛查能力高达 77%。总之,HPV 日益复杂,以及在消除宫颈癌时代对质量保证的要求,需要国际社会努力支持 HPV 类型的能力验证和公认的质量和秩序。

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