Division of Virology, National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar EN6 3QG, UK.
Division of Virology, National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar EN6 3QG, UK.
Vaccine. 2018 Jul 5;36(29):4339-4345. doi: 10.1016/j.vaccine.2018.05.076. Epub 2018 Jun 9.
The current gold-standard potency test for inactivated influenza vaccines is the single radial immunodiffusion (SRD) assay. A number of alternative potency tests for inactivated influenza vaccines have been proposed in recent years. Evaluation of these new potency tests commonly involves comparison with SRD, in order to ascertain that the new method obtains values that correlate with those measured by the standard potency test. Here, we extended comparison of two methods, reverse-phase HPLC and SDS-PAGE, with SRD by assessing the methods' capacity to detect loss of potency induced by various deliberate treatments of vaccine samples. We demonstrate that neither of these methods detected the loss of potency observed by SRD; importantly, neither SDS-PAGE nor reverse-phase HPLC reflected results from mouse experiments that showed decreased immunogenicity and protection in vivo. These results emphasise the importance of assessing the stability-indicating nature, ie the ability to measure loss of vaccine potency, of any potential new potency assay.
目前用于检测灭活流感疫苗效价的金标准方法是单向琼脂扩散法（SRD）。近年来，人们提出了许多替代的灭活流感疫苗效价检测方法。这些新方法的评估通常涉及与 SRD 的比较，以确定新方法获得的值与标准效价检测方法测量的值相关。在这里，我们通过评估这两种方法（反相高效液相色谱法和 SDS-PAGE）检测各种疫苗样品经故意处理后效价降低的能力，将其与 SRD 进行了比较。我们证明这两种方法都无法检测到 SRD 检测到的效价降低；重要的是，SDS-PAGE 和反相高效液相色谱法都无法反映小鼠实验的结果，该实验表明体内免疫原性和保护力降低。这些结果强调了评估任何潜在新效价检测方法的稳定性指示特性（即检测疫苗效价降低的能力）的重要性。
