Validation and optimization of the in vitro LAL test for detection of endotoxin in hepatitis B vaccines

Endotoxin has been detected by the Limulus amoebocyte lysate (LAL) test. However, aluminum hydroxide used as an adjuvant and adsorbent for the recombinant protein antigen is known to increase efficacy of lipopolysaccharide vaccine in vivo thus interfering endotoxin test. The aim of this study is to determine effect of aluminum hydroxide on the LAL test using the hepatitis B vaccine as a model and to optimize the LAL test condition not to be interfered by aluminum gydroxide. (omitted)