Trombetta Claudia Maria, Perini Daniele, Mather Stuart, Temperton Nigel, Montomoli Emanuele
Department of Molecular and Developmental Medicine, University of Siena, Via Aldo Moro, 53100 Siena, Italy.
VisMederi srl, Enterprise in Life Sciences, Via Fiorentina 1, 53100 Siena, Italy.
Vaccines (Basel). 2014 Oct 13;2(4):707-34. doi: 10.3390/vaccines2040707.
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.
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）、单向辐射溶血（SRH）和病毒中和（VN）试验。HI和SRH是成熟且可重复的技术，而VN要求更高。每种新型流感疫苗都需要满足欧洲药品管理局（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试验，且针对两个不同的目标群体——健康成年人和老年人，但未考虑其他疫苗接种年龄组（即儿童）。本次及时综述的目的是强调当前流感疫苗保护相关性的现状，并强调修订现行标准和试验的必要性。除了SRH和HI试验外，还需要考虑其他技术（如VN试验、基于假型的中和试验、神经氨酸酶和细胞介导免疫试验）所提供的技术优势，并通过EMA标准进行规范，因为它们可为有效疫苗的开发提供诸多显著优势。
