[Measurement of endotoxin in blood products using an endotoxin-specific Limulus test reagent and its relation to...

The amounts of endotoxin in commercial blood products were measured by the turbidimetric kinetic Limulus test with an ordinary reagent (LAL-HS) and a new endotoxin-specific reagent (LAL-ES). LAL-ES contains a sufficient amount of a water-soluble (1----3)-beta-D-glucan derivative as a blocker of the (1----3)-beta-D-glucan-mediated coagulation pathway in the reaction of the Limulus amebocyte lysate. The amounts of endotoxin in albumin and globulin products measured with LAL-ES agreed with pyrogenic activities in rabbits, but those measured with LAL-HS did not. Added endotoxin in the blood products was well recovered with LAL-ES, but that in some products was excessively recovered with LAL-HS. The amounts of endotoxin in diphtheria-pertussis-tetanus combined vaccines measured with LAL-HS and LAL-ES agreed with the pyrogenic activities in rabbits. The results suggested the existence of a false-positive substance like beta-glucan in the blood products but not in the vaccine. LAL-ES is more suitable for the detection of endotoxin in blood products than LAL-HS.