Departments of Laboratory Medicine, Medical Epidemiology & Biostatistics, Karolinska Institute and Hospital, Stockholm, Sweden.
Department of Laboratory Medicine, Division of Medical Microbiology, Lund University, Skane Laboratory Medicine, Lund, Sweden.
J Clin Virol. 2018 Apr;101:74-85. doi: 10.1016/j.jcv.2018.01.016. Epub 2018 Feb 10.
Accurate and internationally comparable human papillomavirus (HPV) DNA detection and typing services are essential for HPV vaccine research and surveillance.
This study assessed the proficiency of different HPV typing services offered routinely in laboratories worldwide.
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.
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.
The regularly issued global proficiency program has documented an ongoing worldwide improvement in comparability and reliability of HPV genotyping services.
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。
本研究评估了全球实验室常规提供的不同 HPV 分型服务的能力。
HPV 实验室网络 (LabNet) 设计了可定期发布的国际能力验证计划。2013 年和 2014 年的 HPV 基因分型能力验证计划分别包含 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 68b）的 16 种 HPV 类型的纯化质粒和 3 个提取对照组成。熟练的分型定义为在 HPV16 和 HPV18 的 50 国际单位和其他 14 种 HPV 类型的 500 基因组当量的单重和多重感染中均能检测到，且特异性至少为 97%。
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。使用了 34 种不同的 HPV 基因分型检测方法，特别是线性阵列、HPV 直接流动芯片、GenoFlow HPV 阵列、Anyplex HPV 28、Inno-LiPa 和 PGMY-CHUV 检测。观察到灵敏度和特异性呈上升趋势。2013 年，59 个数据集（44%）的准确率为 100%，而 2014 年则有 86 个数据集（59%）达到 100%。与 2008 年首次发布的能力验证计划相比，这是一个明显的进步，当时只有 19 个数据集（26%）完全熟练。
定期发布的全球能力验证计划记录了全球 HPV 基因分型服务可比性和可靠性的持续提高。
