Trombetta Claudia Maria, Perini Daniele, Vitale Licia, Cox Rebecca Jane, Stanzani Valerio, Piccirella Simona, Montomoli Emanuele
Department of Molecular and Developmental Medicine, University of Siena, Via Aldo Moro, 53100 Siena, Italy.
VisMederi srl, Enterprise in Life Science, Via Fiorentina 1, 53100 Siena, Italy.
J Immunol Methods. 2015 Jul;422:95-101. doi: 10.1016/j.jim.2015.04.009. Epub 2015 Apr 22.
The Single Radial Haemolysis (SRH) assay is a serological method widely used for measuring antibodies against influenza viruses. Despite the broad application and recommendation by licensing authorities, the SRH assay has not been standardized. The aim of this study is to demonstrate how the SRH assay satisfies validation parameters of regulatory agencies in terms of specificity, precision, repeatability, intermediate precision, linearity, accuracy and robustness. This study shows that the SRH is a rapid, simple, reliable and reproducible assay, which requires only small volumes of serum samples and can be easily standardized.
单径向溶血（SRH）测定法是一种广泛用于检测抗流感病毒抗体的血清学方法。尽管该方法得到了广泛应用并获得了许可机构的推荐，但SRH测定法尚未标准化。本研究的目的是证明SRH测定法如何在特异性、精密度、重复性、中间精密度、线性、准确性和稳健性方面满足监管机构的验证参数。本研究表明，SRH是一种快速、简单、可靠且可重复的测定法，只需要少量血清样本，并且易于标准化。
