Rastogi S C, Hochstein H D, Seligmann E B
J Clin Microbiol. 1977 Aug;6(2):144-8. doi: 10.1128/jcm.6.2.144-148.1977.
To determine laboratory-to-laboratory variability of the limulus amoebocyte lysate (LAL) test for evaluating endotoxin content in influenza virus vaccine, a collaborative study was designed. Participants were six influenza virus vaccine manufacturers and the Bureau of Biologics (BoB). Lysate lot 116, Reference Influenza Virus Vaccine for Endotoxin Assay E-1, and four test vaccines having different ratios of LAL activity relative to reference E-1 were supplied by the BoB. Each laboratory used its normal test procedure. All vaccines were coded. One pair (reference and test) of vaccines per day was tested for 4 days a week over a 4-week period. All data were analyzed at the BoB. The degree of variability experienced by testing laboratories was estimated by the study. This estimate did not conflict with experience gained from previous routine testing in any of the participating laboratories. A statistical approach to the evaluation of LAL data from testing influenza virus vaccine for endotoxin content was developed based upon the overall variation obtained from the collaborative study.
为确定用于评估流感病毒疫苗内毒素含量的鲎试剂（LAL）检测在不同实验室间的变异性，设计了一项协作研究。参与者包括六家流感病毒疫苗生产商和生物制品局（BoB）。生物制品局提供了裂解物批次116、用于内毒素检测的参考流感病毒疫苗E-1以及四种相对于参考E-1具有不同LAL活性比例的试验疫苗。每个实验室采用其常规检测程序。所有疫苗均进行了编码。在4周的时间里，每周4天，每天检测一对（参考和试验）疫苗。所有数据均在生物制品局进行分析。该研究估计了检测实验室所经历的变异程度。这一估计与任何参与实验室之前的常规检测经验均不冲突。基于协作研究获得的总体变异情况，开发了一种统计方法来评估检测流感病毒疫苗内毒素含量的LAL数据。
