Division of Virology, National Institute for Biological Standards and Control, South Mimms, Potters Bar, Hertfordshire, UK.
Int J Cancer. 2010 Jun 15;126(12):2969-83. doi: 10.1002/ijc.25039.
A World Health Organization collaborative study was conducted to evaluate candidate international standards for human papillomavirus (HPV) Type 16 DNA (NIBSC code 06/202) and HPV Type 18 DNA (NIBSC code 06/206) for use in the amplification and detection steps of nucleic acid-based assays. The freeze-dried candidate international standards were prepared from bulk preparations of cloned plasmid containing full-length HPV-16 or HPV-18 genomic DNA. Nineteen laboratories from 13 countries participated in the study using a variety of commercial and in-house quantitative and qualitative assays. The data presented here indicate that, upon freeze-drying, there is no significant loss in potency for the candidate HPV-18 DNA and a slight loss in potency for the candidate HPV-16 DNA; although this is likely not scientifically relevant when assay precision is considered. In general, the individual laboratory mean estimates for each study sample were grouped +/- approximately 2 log(10) around the theoretical HPV DNA concentration of the reconstituted ampoule (1 x 10(7) HPV genome equivalents/mL). The agreement between laboratories is improved when potencies are made relative to the candidate international standards, demonstrating their utility in harmonizing amplification and detection steps of HPV-16 and -18 DNA assays. Degradation studies indicate that the candidate international standards are extremely stable and suitable for long-term use. Based on these findings, the candidate standards were established as the 1st WHO international standards for HPV-16 DNA and HPV-18 DNA, each with a potency of 5 x 10(6) international units (IU) per ampoule or 1 x 10(7) IU mL(-1) when reconstituted as directed.
世界卫生组织合作开展了一项研究，旨在评估人乳头瘤病毒（HPV）16 型 DNA（NIBSC 编码 06/202）和 HPV18 型 DNA（NIBSC 编码 06/206）候选国际标准，用于核酸检测的扩增和检测步骤。冻干候选国际标准品由包含全长 HPV-16 或 HPV-18 基因组 DNA 的克隆质粒的大量制剂制备。来自 13 个国家的 19 个实验室使用各种商业和内部定量和定性检测方法参与了该研究。这里呈现的数据表明，在冻干后，候选 HPV-18 DNA 的效力没有明显损失，候选 HPV-16 DNA 的效力略有损失；尽管当考虑到检测精度时，这可能在科学上并不相关。通常，每个研究样本的个体实验室平均值估计值在大约 2 个对数（10）范围内围绕再配制安瓿的理论 HPV DNA 浓度（1 x 10(7)HPV 基因组当量/mL）分组。当相对于候选国际标准品进行效力评估时，实验室之间的一致性得到改善，证明了它们在协调 HPV-16 和 -18 DNA 检测步骤方面的实用性。降解研究表明候选国际标准品极其稳定，适合长期使用。基于这些发现，候选标准被确立为 HPV-16 DNA 和 HPV-18 DNA 的第 1 个世界卫生组织国际标准，每个标准品的效力为 5 x 10(6)国际单位（IU）/安瓿或 1 x 10(7)IU/mL，按说明再配制。
