Abstract：
Determination of the potency of a vaccine is critical to ensuring that an appropriate dose is delivered, lot-to-lot consistency is maintained, and that the formulation is stable over the life of the vaccine. The potency of inactivated influenza vaccines is determined routinely by the Single Radial Immunodiffusion (SRID) assay. A number of alternative potency assays have been proposed and have been under evaluation in recent years. The aim of this study was to compare a surface plasmon resonance-based assay and two different enzyme linked immunoassays against the current potency assay, SRID, and against mouse immunogenicity when haemagglutinin antigen of the A(H1N1)pdm09 component of an inactivated influenza vaccine is stressed by elevated temperature, low pH and freezing. This analysis demonstrated that the alternative assays had good correspondence with SRID for samples from most stress conditions and that the immunogenicity in mice corresponded with potency in SRID for all stress samples. Subject to further analysis, the assays have been shown to have the potential to possibly replace, and at least complement, SRID.
摘要：
确定疫苗的效力对于确保提供适当的剂量至关重要。保持批次之间的一致性，并且该制剂在疫苗的整个生命周期内是稳定的。通过单一放射免疫扩散(SRID)测定常规地测定灭活流感疫苗的效力。已经提出了许多替代的效力测定,并且近年来已经在评估中。这项研究的目的是比较基于表面等离子体共振的测定和两种不同的酶联免疫测定与当前的效力测定，SRID,当灭活流感疫苗的A（H1N1）pdm09成分的血凝素抗原受到高温胁迫时，针对小鼠的免疫原性，低pH和冷冻。该分析表明，对于来自大多数应激条件的样品，替代测定法与SRID具有良好的对应关系，并且对于所有应激样品，小鼠中的免疫原性与SRID的效力相对应。有待进一步分析，这些试验已被证明有可能取代，至少是补充，SRID。
