ToxinSensor™ Single Test Kit is designed to be a qualitative In Vitro end-point endotoxin test for human and animal parenteral drugs, biological products, and medical devices. Limulus Amebocyte Lysate (LAL) as supplied is to be reconstituted with sample or control directly. There is no need to reconstitute the system with LAL Reagent Water before use. After incubation for 1 hour, and in the presence of endotoxin, gelation occurs; in the absence of endotoxin, gelation does not occur. GenScript supply a series of ToxinSensor™ Single Test Kits with different sensitivity (0.015 EU/ml, 0.03 EU/ml, 0.06 EU/ml, 0.125 EU/ml and 0.25 EU/ml). When using the ToxinSensor™ Single Test Kit, you just need to add 200µl of sample or control to LAL, then, wait for the required incubation time to allow for gelation to 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.