Minor Philip D
National Institute for Biological Standards and Control/MHRA, Blanche Lane, Potters Bar, Hertfordshire EN6 3QG, UK.
Vaccines (Basel). 2015 Feb 5;3(1):90-104. doi: 10.3390/vaccines3010090.
The potency of vaccines must be determined to ensure that the appropriate dose is given. The manufacture and assessment of influenza vaccines are complicated by the continuously changing nature of the pathogen, which makes efficacy estimates difficult but also confounds attempts to produce a well-validated, consistent potency assay. Single radial diffusion has been used for decades and provides a relatively simple way to measure the amount of biologically active materials present in the vaccine. It requires reagents, which are updated on a regular, frequently yearly, basis and alternative methods continue to be sought.
必须确定疫苗的效力以确保给予适当剂量。流感疫苗的生产和评估因病原体不断变化的特性而变得复杂,这使得疗效评估困难,也使得生产经过充分验证、一致的效力测定方法的尝试受挫。单向辐射扩散已使用数十年,提供了一种相对简单的方法来测量疫苗中存在的生物活性物质的量。它需要定期(通常每年)更新试剂,并且仍在不断寻求替代方法。