6] Measurement of endotoxin levels in hemoglobin preparations

Abstract

Publisher Summary Endotoxin (lipopolysaccharide, LPS) is a glycolipid component of the outer portion of the cell wall of gram-negative bacteria. Bacterial endotoxin, which is responsible for the fever, disseminated intravascular coagulation, hypotension, and cardiovascular shock that frequently accompany gram-negative septicemia, produces biological and pathophysiological effects at very low concentrations (in the picogram per milliliter range), even in the absence of living bacteria. FDA guidelines require that sufficiently low endotoxin levels be documented to allow human use of parenteral drugs or medical devices because endotoxemia is associated with substantial morbidity and mortality. This chapter focuses on the use of the Limulus amebocyte lysate test to measure endotoxin levels in hemoglobin preparations. It also describes its more general applications for the detection of endotoxin in protein solutions and blood. The Limulus amebocyte lysate (LAL) test is an in vitro biological assay for endotoxin, based on endotoxin activation of the horseshoe crab coagulation cascade. The chapter also discusses the technical considerations concerning related to LAL testing of hemoglobin.