Continuing global improvement in human papillomavirus DNA genotyping services: The 2013 and 2014 HPV LabNet international proficiency studies
Continuing global improvement in human papillomavirus DNA genotyping services: The 2013 and 2014 HPV LabNet international proficiency studies
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DOI：
10.1016/j.jcv.2018.01.016
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发表时间：
2018-04-01
影响因子：
8.8
通讯作者：
Dillner, Joakim
中科院分区：
文献类型：
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作者：
Eklund, Carina;Forslund, Ola;Dillner, Joakim
背景：准确且具有国际可比性的人乳头瘤病毒 (HPV) DNA 检测和分型服务对于 HPV 疫苗研究和监测至关重要。目的：本研究评估了世界各地实验室常规提供的不同 HPV 分型服务的熟练程度。研究设计：HPV 实验室网络 (LabNet) 设计了可定期发布的国际熟练程度小组。 2013年和2014年的HPV基因分型能力小组分别包含43个和41个编码样本，由16种HPV类型（HPV 6、11、16、18、31、33、35、39、45、51、52、56、58、59、66、68a和HPV）的纯化质粒组成。 68b) 和 3 个提取控制。熟练分型定义为检测 50 个国际单位的 HPV 16 和 HPV 18 以及其他 14 种 HPV 类型的 500 个基因组当量，特异性至少为 97%。 结果：96 个实验室在 2013 年提交了 136 个数据集，121 个实验室在 2014 年提交了 148 个数据集。 34 种不同的 HPV 基因分型测定使用了线性阵列、HPV 直接流式芯片、GenoFlow HPV 阵列、Anyplex HPV 28、Inno-LiPa 和 PGMY-CHUV 检测。观察到敏感性和特异性增加的趋势。 2013 年，59 个数据集 (44%) 达到 100% 熟练程度，而 2014 年有 86 个数据集 (59%)。与 2008 年发布的第一个熟练程度小组相比，这是一个明显的进步，当时只有 19 个数据集 (26%) 完全熟练。结论：定期发布的全球熟练程度计划记录了全球范围内 HPV 基因分型的可比性和可靠性持续改进服务。
Background: Accurate and internationally comparable human papillomavirus (HPV) DNA detection and typing services are essential for HPV vaccine research and surveillance.Objectives: This study assessed the proficiency of different HPV typing services offered routinely in laboratories worldwide.Study design: The HPV Laboratory Network (LabNet) has designed international proficiency panels that can be regularly issued. The HPV genotyping proficiency panels of 2013 and 2014 contained 43 and 41 coded samples, respectively, composed of purified plasmids of sixteen HPV types (HPV 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68a and 68b) and 3 extraction controls. Proficient typing was defined as detection in both single and multiple infections of 50 International Units of HPV 16 and HPV 18 and 500 genome equivalents for the other 14 HPV types, with at least 97% specificity.Results: Ninety-six laboratories submitted 136 datasets in 2013 and 121 laboratories submitted 148 datasets in 2014. Thirty-four different HPV genotyping assays were used, notably Linear Array, HPV Direct Flow-chip, GenoFlow HPV array, Anyplex HPV 28, Inno-LiPa, and PGMY-CHUV assays. A trend towards increased sensitivity and specificity was observed. In 2013, 59 data sets (44%) were 100% proficient compared to 86 data sets (59%) in 2014. This is a definite improvement compared to the first proficiency panel, issued in 2008, when only 19 data sets (26%) were fully proficient.Conclusion: The regularly issued global proficiency program has documented an ongoing worldwide improvement in comparability and reliability of HPV genotyping services.