Thermo Scientific™ Pierce™ Rapid Gel Clot Endotoxin Assay Kits

Description

• Endotoxin is a lipopolysaccharide (LPS) that constitutes much of the outer membrane of the cell wall in gram-negative bacteria
• LPS is the most abundant antigen on the cell surface of most gram-negative bacteria
• Thermo Fisher Scientific Pierce Rapid Gel Clot Endotoxin Assay kits provide rapid and easy-to-read qualitative results indicating the presence or absence of endotoxins
• They are best suited for samples that are viscous or highly colored and are available in a variety of sensitivities: 0.03, 0.125, 0.25, and 0.5 EU/mL
• 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.