Accurate Endotoxin Testing: PYROSTAR™ NEO
Endotoxins are a component of the outer membrane of gram-negative bacteria. They are released from bacteria primarily during cell lysis and are ubiquitous in the environment. Moreover, endotoxins are strong pyrogens, and, if they gain access to the bloodstream, may cause fever, inflammation, septic shock, and hemorrhage. Because of the iniquitousness and pronounced pyrogenic activities of endotoxins, injectable pharmaceuticals and medical devices are routinely tested for endotoxin contamination.
Historically, the in vivo rabbit pyrogen test was an early method for pyrogen testing, which also detected, but was not specific for, endotoxins. However, it has largely been replaced by the in vitro Limulus amebocyte lysate (LAL) assay, which is specific for endotoxins, and, in some instances, by the monocyte activation test, which detects all pyrogens (Suvarna et al., 2015).