Endotoxin Detection Kit (Recombinant Factor C)

MCE Endotoxin Detection Kit (Recombinant Factor C) is suitable for the detection of endotoxins in therapeutic injectable drugs for human use (such as chemical drugs, antibiotics, and biologics), as well as in medical devices including dialysis fluids and implantable devices. It can be applied throughout raw material screening, process development, manufacturing, and commercialization stages.

Principle of Detection: This assay utilizes a genetically engineered recombinant Factor C (rFC) protein derived from Tachypleus tridentatus. Upon binding to endotoxins, the rFC is activated and cleaves a fluorogenic substrate, releasing a fluorescent signal. The fluorescence intensity is proportional to the endotoxin concentration, enabling quantitative detection.

Features of MCE Endotoxin Detection Kit (Recombinant Factor C)

1. Endpoint fluorescence measurement, providing quantification performance comparable to other LAL-based methods.

2. High specificity: detects endotoxins exclusively with no interference from Factor G pathways.

3. High sensitivity: detection range of 0.005-5 EU/mL.

4. Recombinant expression ensures good batch-to-batch consistency.

5. Ready-to-use liquid reagents simplify the workflow.

6. Animal component-free formulation enhances supply security.

7. Eliminates reliance on animal-derived reagents, aligning with the 3R principles (Replacement, Reduction, and Refinement).