Report of a collaborative study to calibrate the Second International Standard for parvovirus B19 antibody
Report of a collaborative study to calibrate the Second International Standard for parvovirus B19 antibody
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DOI：
10.1016/j.biologicals.2004.09.004
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发表时间：
2004-12-01
期刊：
影响因子：
1.7
通讯作者：
Heath, A
中科院分区：
文献类型：
--
作者：
Ferguson, M;Heath, A
开展了一项合作研究，以评估取代第一个细小病毒B19抗体、人血清国际标准的适宜性，并在IU中对其进行校准。拟议的标准。这是来自16名美国献血者的血清池，与第一个国际标准、编码副本或建议的标准以及来自单个献血者的血浆样本一起进行检测。来自8个国家的9个实验室参与了这项研究，并使用了5种不同的检测试剂盒。两个试剂盒含有VP1+VP2，一个试剂盒仅含有VP1，两个试剂盒。其中一个由五名参与者使用，只含有VP2。用含有不同抗原VP1、VP2或VP1+VP2的试剂盒检测建议的标准和单个血浆的差异。然而，由于VP1是一种次要的衣壳蛋白，它本身不会组装成病毒堤防颗粒，而且个体的主要反应似乎是针对VP2。这项研究的结果显示，编码为011602的建议标准适合作为细小病毒B19血清免疫球蛋白的替代国际标准，该制剂于2003年2月被世界卫生组织生物标准化专家委员会确定为第二个细小病毒B19抗体国际标准，即人血浆，单位为77IU/支。(C)2004年国际生物药品协会。爱思唯尔有限公司出版。保留所有权利。
A collaborative study was undertaken to assess the suitability of a replacement for the First International Standard for parvovirus B19 IgG, human serum and to calibrate it in IU. The proposed standard. which is a pool of sera from 16 US blood donors, was assayed along with the First International Standard, a coded duplicate or the proposed standard and a plasma sample from a single blood donor. Nine laboratories from eight countries participated in the studies and five different assay kits were used. Two kits contained VP1 + VP2, one kit contained VP1 only and two kits. one of which was used by five participants contained VP2 only. Differences in detection of the proposed standard and the individual plasma were observed with as say kits containing different antigens, VP1, VP2 or VP1 + VP2. However, since VP1 is a minor capsid protein and on its own does not assemble into virus Dike particles and the dominant response in individuals appears to be against VP2. it was considered reasonable to utilize only the data from kits containing VP2 antigen for the calibration of the proposed standard.The results of this study demonstrated that the proposed standard coded 011602 was suitable to serve as the replacement International Standard for parvovirus B19, serum IgG, and this preparation was established as the Second International Standard for parvovirus B 19 antibody, plasma human, with an assigned unitage of 77 IU per ampoule by the Expert Committee on Biological Standardisation of the World health Organisation in February 2003. (C) 2004 The International Association for Biolgoicals. Published by Elsevier Ltd. All rights reserved.