Characterization of Reference Materials for Human Antiserum to Pertussis Antigens by an International Collaborative Study
Characterization of Reference Materials for Human Antiserum to Pertussis Antigens by an International Collaborative Study
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DOI：
10.1128/cvi.00372-08
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发表时间：
2009-03-01
影响因子：
--
通讯作者：
Gaines-Das, Rose
中科院分区：
文献类型：
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作者：
Xing, Dorothy;von Koenig, Carl Heinz Wirsing;Gaines-Das, Rose
酶联免疫吸附试验（ELISA）已被广泛用于评估百日咳疫苗接种和感染的抗体反应。一个共同的参考血清对于这些测定的标准化是必不可少的。然而，没有国际公认的参考血清可用。应世界卫生组织（卫生组织）生物标准化专家委员会（ECBS）的要求，已编制了一套四项候选国际标准。在一项国际合作研究中，来自15个国家的22个实验室对这些候选材料进行了适用性评估，并与广泛使用的美国参考百日咳抗血清（人）批号3、4和5进行了比较。实验室使用已建立的免疫测定法测定百日咳毒素（PT）、丝状血凝素（FHA）、peractn （PRN）和菌毛（Fim2&3）的免疫球蛋白G （IgG）和IgA抗体。研究结果表明，这四种候选物质均适合作为国际标准。经与会人员同意，建议ECBS将编码为06/140的候选物质建立为第一个百日咳抗血清（人）国际标准，其指定国际单位（IU）如下：IgG抗pt， 335 IU/安瓿；IgA抗pt， 65 IU/安瓿；IgG抗fha， 130 IU/安瓿；IgA抗fha， 65 IU/安瓿；抗prn IgG， 65 IU/安瓿；IgA抗prn， 42 IU/安瓿。目前还没有正式的单位被提议用于抗fim2和3，因为大多数检测使用的是纤维抗原的混合物。此外，编码为06/142的候选材料已被提议作为世卫组织测定系统表征的工作制剂。
Enzyme-linked immunosorbent assay (ELISA) has been widely used to evaluate antibody responses to pertussis vaccination and infection. A common reference serum is essential for the standardization of these assays. However, no internationally recognized reference serum is available. At the request of the Expert Committee on Biological Standardization (ECBS) of the World Health Organization (WHO), a set of four candidate international standards has been prepared. These candidate materials have been assessed for suitability and compared to the widely used U. S. reference pertussis antiserum (human) lot 3, lot 4, and lot 5 by 22 laboratories from 15 countries in an international collaborative study. Laboratories measured immunoglobulin G (IgG) and IgA antibodies to pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae (Fim2&3) using their established immunoassays. The results of this study showed each of the four candidates to be suitable as an international standard. With the agreement of the participants, a recommendation has been made to the ECBS that the candidate material coded 06/140 be established as the First International Standard for pertussis antiserum (human), with the following assigned international units (IU): IgG anti-PT, 335 IU/ampoule; IgA anti-PT, 65 IU/ampoule; IgG anti-FHA, 130 IU/ampoule; IgA anti-FHA, 65 IU/ampoule; IgG anti-PRN, 65 IU/ampoule; and IgA anti-PRN, 42 IU/ampoule. No formal units have been proposed for anti-Fim2& 3 because most assays used a mixture of fimbrial antigens. In addition, the candidate material coded 06/142 has been proposed as a WHO working preparation for characterization of assay systems.