Fryer Jacqueline F, Heath Alan B, Wilkinson Dianna E, Minor Philip D
Division of Virology, NIBSC, Medicines and Healthcare Products Regulatory Agency, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK.
Biostatistics, NIBSC, Medicines and Healthcare Products Regulatory Agency, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK.
Biologicals. 2016 Sep;44(5):423-33. doi: 10.1016/j.biologicals.2016.04.010. Epub 2016 Jul 22.
Variability in viral load measurements using nucleic acid amplification techniques (NAT) has a significant impact on the management of Epstein-Barr virus (EBV)-associated diseases, and has highlighted a need for standardisation of these measurements. The aim of this collaborative study was to evaluate the suitability of a range of candidate reference materials to harmonise EBV viral load measurements in a wide range of NAT assays. Candidate materials included lyophilised and liquid whole virus preparations of the EBV B95-8 strain, and preparations of Namalwa and Raji cells. Variability between the individual laboratory mean estimates for each candidate was 2.5 log10 copies/mL. The agreement between laboratories was improved when the potency of each candidate was expressed relative to the lyophilised B95-8 preparation. The results of the study indicate the suitability of this candidate as the 1st WHO International Standard for EBV for NAT. It was established in October 2011 by the WHO's Expert Committee on Biological Standardisation with an assigned potency of 5 × 10(6) International Units (IU) (NIBSC code 09/260). It is intended to be used for the calibration of secondary reference materials, used in EBV NAT assays, in IU, thereby improving the comparability of patient viral load measurements.
使用核酸扩增技术（NAT）进行病毒载量测量的变异性对爱泼斯坦-巴尔病毒（EBV）相关疾病的管理有重大影响，并凸显了对这些测量进行标准化的必要性。这项合作研究的目的是评估一系列候选参考物质在广泛的NAT检测中协调EBV病毒载量测量的适用性。候选物质包括EBV B95-8株的冻干和液体全病毒制剂，以及Namalwa和Raji细胞制剂。每个候选物质的各个实验室平均估计值之间的变异性为2.5 log10拷贝/毫升。当每个候选物质的效价相对于冻干的B95-8制剂表示时，实验室之间的一致性得到了改善。研究结果表明该候选物质适合作为世卫组织第一个用于NAT的EBV国际标准。它于2011年10月由世卫组织生物标准化专家委员会确定，指定效价为5×10(6)国际单位（IU）（NIBSC编码09/260）。其旨在用于校准EBV NAT检测中使用的二级参考物质，以国际单位表示，从而提高患者病毒载量测量的可比性。
