These Rapid Gel Clot Endotoxin Assay kits have a fast, efficient protocol, are reproducible and contain all the reagents and supplies such as positive control tubes, endotoxin-free tubes, and pipette tips required for each test. Each kit is sufficient for 10 tests, using 0.5 mL of test sample.

Pierce Rapid Gel Clot Endotoxin Assay kits use amebocyte lysates derived from the Limulus horseshoe crab hemolymph to detect endotoxin levels in samples. Limulus amebocyte lysate (LAL) is widely used as a simple and sensitive assay for detection of endotoxins. When endotoxin encounters the amebocyte lysate, a series of enzymatic reactions form a gel-like clot. In a positive test, a clot will form in the sample tube, indicating that the amount of endotoxin in the sample is greater than or equal to the listed sensitivity (in EU/mL) of the kit. A lack of gel clot formation in the tube is considered a negative result, indicative of an endotoxin concentration in the test tube below the kit’s sensitivity.

Endotoxins are released in their surrounding environment when gram-negative bacteria undergo normal cell division or in large concentrations when they are damaged or undergo cell lysis. Given endotoxins are pyrogenic (induce fever) in mammals, identifying and monitoring endotoxin levels is extremely important in many fields. Endotoxin testing of raw materials, intermediates, and final drug products is essential for patient safety. Each kit lot has a defined assay incubation time that is listed in the Certificate of Analysis accompanying each kit. This kit is not licensed by the FDA and is not to be used for the end-product release of pharmaceutical drugs, devices, or biologics that are FDA regulated.