Endotoxin Rapid Gel Clot Assay Test

Endotoxin, a lipopolysaccharide located in the outer membrane of gram-negative bacteria including E. coli, Salmonella, shigella, Vibrio cholerae, and Haemophilus influenzae, is released passively as a result of bacteria death and cell lysis. It is highly heat-stable and resistant to destruction by sterilization processes, making it a prevalent contaminant in medical products. Even a minuscule amount, as little as 1 mg, can elicit a response from the innate immue system, potentially leading to shock and fatal outcomes. Therefore, closely monitoring of endotoxin levels in water during the reprocessing of medical products and dialysis is crucial.

Rapid Gel Clot Endotoxin Assay Test kit

• 10 sample kit or single test kit
• Sensitivity of 0.25 EU/ml, 0.125 EU/ml and 0.03 EU/ml are available.
• Test result can be less than 25 minutes.
• Each kit contains sample test tubes, endotoxin test tubes (Positive Product Control-PPC), endotoxin-free sample bottle and pyrogen-free pipettors.
• Applications: Detection of water, dialysate and water for dialysis.
• Reference: United States Pharmacopoeia (USP), General Chapter <85>, Bacterial Endotoxins Test (BET) and China Pharmacopoeia 2020 version, Volume Four, general rules 1143.
• Each lot will be delivered together with a certificate of analysis.