Thermo Scientific™ Pierce™ Rapid Gel Clot Endotoxin Assay Kits

Rapid Gel Clot Endotoxin Assay Kits provide rapid and easy-to-read results for presence or absence of gram-negative bacterial endotoxin in the test sample. The kit delivers a qualitative 'Pass' or 'Fail' result, with kit sensitivity options ranging from 0.03 to 0.5 EU/mL, each supporting 10 tests.

Catalog Number	Mfr. No.	Assay Sensitivity
PIA43879	Thermo Scientific™ A43879	0.03 EU/mL
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PIA43880	Thermo Scientific™ A43880	0.125 EU/mL
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PIA43881	Thermo Scientific™ A43881	0.25 EU/mL
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PIA43882	Thermo Scientific™ A43882	0.5 EU/mL
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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.

Specifications

• Content And Storage: • Positive Control Tubes
  • Endotoxin-Free Sample Reaction Tubes
  • Endotoxin-Free Pipette Tips
  • Endotoxin-Free Sample Bottles
  
  Store Sample and Positive Control Reaction Tubes at 4°C.
  Store pipette tips and sample bottles at room temperature.
  
  
• Product Line: Pierce™
• Type: Endotoxin Assay Kit
• Format: Kit

• Assay: End-Point Gel Clot LAL Assay
• For Use With (Application): 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. For Research Use Only.
• Sufficient For: 10 Assays

For Research Use Only. Not for use in diagnostic procedures.