Global Proficiency Study of Human Papillomavirus Genotyping
Global Proficiency Study of Human Papillomavirus Genotyping
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DOI：
10.1128/jcm.00918-10
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发表时间：
2010-11-01
影响因子：
9.4
通讯作者：
Dillner, Joakim
中科院分区：
文献类型：
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作者：
Eklund, Carina;Zhou, Tiequn;Dillner, Joakim
人乳头瘤病毒（HPV）DNA检测和分型方法的国际可比性质量保证对于评估HPV疫苗以及有效监测和实施HPV疫苗接种计划至关重要。因此，世界卫生组织（WHO）HPV实验室网络（LabNet）设计了一项国际能力研究。在世卫组织网站上宣布后，作出回应的实验室使用一种或多种常规检测方法对43个编码样本进行了HPV分型，这些样本由16种HPV类型的纯化质粒的滴定系列组成（HPV 6、-11、-16、-18、-31、-33、-35、-39、-45、-51、-52、-56、-58、-59、-66和-68）。至少50 IU的HPV 16或HPV 18 DNA和500个基因组当量（GE）的其他14种HPV类型（在单一和多种HPV类型的样本中）的检测被认为是熟练的。全世界54个实验室共提交了84组数据。使用了超过21种HPV基因分型检测。常用的方法是线性阵列、Lineblot、InnoLiPa、临床阵列、类型特异性实时PCR、PCR-Luminex和微阵列测定。主要致癌HPV类型（HPV 16和-18）分别在89.7%（70/78）和92.2%（71/77）的数据集中检出。HPV 56、59和68型是最不常见的检测类型（不到80%的数据集）。28个数据集报告了多个假阳性结果，被认为是不熟练的。总之，我们发现，可追溯到国际标准的国际能力研究可以为不同的HPV分型检测提供标准化的质量保证，并可以比较全球不同实验室生成的数据。
Internationally comparable quality assurance of Human Papillomavirus (HPV) DNA detection and typing methods is essential for evaluation of HPV vaccines and effective monitoring and implementation of HPV vaccination programs. Therefore, the World Health Organization (WHO) HPV Laboratory Network (LabNet) designed an international proficiency study. Following announcement at the WHO website, the responding laboratories performed HPV typing using one or more of their usual assays on 43 coded samples composed of titration series of purified plasmids of 16 HPV types (HPV6, -11, -16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, and -68). Detection of at least 50 IU of HPV16 or HPV18 DNA and of 500 genome equivalents (GE) of the other 14 HPV types (in samples with single and multiple HPV types) was considered proficient. Fifty-four laboratories worldwide submitted a total of 84 data sets. More than 21 HPV-genotyping assays were used. Commonly used methods were Linear Array, Lineblot, InnoLiPa, Clinical Array, type-specific real-time PCR, PCR-Luminex and microarray assays. The major oncogenic HPV types (HPV16 and -18) were detected in 89.7% (70/78) and 92.2% (71/77) of the data sets, respectively. HPV types 56, 59, and 68 were the least commonly detected types (in less than 80% of the data sets). Twenty-eight data sets reported multiple false-positive results and were considered nonproficient. In conclusion, we found that international proficiency studies, traceable to international standards, allow standardized quality assurance for different HPV-typing assays and enable the comparison of data generated from different laboratories worldwide.