Overview of Serological Techniques for Influenza Vaccine Evaluation: Past, Present and Future.
Overview of Serological Techniques for Influenza Vaccine Evaluation: Past, Present and Future.
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DOI：
10.3390/vaccines2040707
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发表时间：
2014-10-13
期刊：
影响因子：
7.8
通讯作者：
Montomoli E
中科院分区：
文献类型：
--
作者：
Trombetta CM;Perini D;Mather S;Temperton N;Montomoli E
常用于定量流感特异性抗体的血清学技术包括血凝抑制（HI）、单向溶血（SRH）和病毒中和（VN）试验。HI和SRH是已建立且可重复的技术，而VN要求更高。每一种新的流感疫苗都需要符合欧洲药品管理局（EMA）发布的严格标准才能获得许可。这些标准目前仅适用于SRH和HI测定，并涉及两个不同的目标群体-健康成人和老年人，但尚未考虑其他疫苗接受者年龄组（即，儿童）。这一及时审查的目的是强调当前关于流感疫苗保护相关因素的情况，并强调需要修订目前使用的标准和检测方法。除了SRH和HI检测外，其他技术（如VN检测、基于假型的中和检测、神经氨酸酶和细胞介导的免疫检测）提供的技术优势需要通过EMA标准进行考虑和监管，因为它们可以为有效疫苗的开发提供许多显著优势。
Serological techniques commonly used to quantify influenza-specific antibodies include the Haemagglutination Inhibition (HI), Single Radial Haemolysis (SRH) and Virus Neutralization (VN) assays. HI and SRH are established and reproducible techniques, whereas VN is more demanding. Every new influenza vaccine needs to fulfil the strict criteria issued by the European Medicines Agency (EMA) in order to be licensed. These criteria currently apply exclusively to SRH and HI assays and refer to two different target groups—healthy adults and the elderly, but other vaccine recipient age groups have not been considered (i.e., children). The purpose of this timely review is to highlight the current scenario on correlates of protection concerning influenza vaccines and underline the need to revise the criteria and assays currently in use. In addition to SRH and HI assays, the technical advantages provided by other techniques such as the VN assay, pseudotype-based neutralization assay, neuraminidase and cell-mediated immunity assays need to be considered and regulated via EMA criteria, considering the many significant advantages that they could offer for the development of effective vaccines.