ToxinSensor™ Gel Clot Endotoxin Assay Kit is intended as an In Vitro end-product endotoxin test for human and animal parenteral drugs, biological products, and medical devices. The Limulus Amebocyte Lysate (LAL) test is a qualitative test for Gram-negative bacterial endotoxin. Limulus Amebocyte Lysate as supplied 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.
The procedures described herein conform with 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.
Note: For specimen preparation, the specimen should be certified free of Beta Glucans contaminant which may come from yeast and cellulosic materials, such as blood products.