GenScript ToxinSensor™ Gel Clot Endotoxin Assay
Kit is designed as a simple and sensitive in vitro end-product endotoxin test
for human and animal parenteral drugs, biological products, and medical
devices. The LAL test is a qualitative test for Gram-negative bacterial endotoxin.
Lyophilized Amebocyte Lysate as supplied in the kit is to be reconstituted with
LAL Reagent Water and then mixed in equal parts with the solution being tested.
After incubation, and in the presence of endotoxin, gelation occurs; in the
absence of endotoxin, gelation does not occur. Lyophilized Amebocyte Lysate
reagent is made from amebocyte lysate from the horseshoe crab (Tachypleus tridentatus).The protocol
described herein conforms to those described in the FDA guideline. Similar
performance requirements for gel clot assays have been published and are
updated regularly in the United States Pharmacopeia.