Recombinant factor C (rFC) assay is a new endotoxin test method using rFC synthetic reagent designed based on the principle of limulus amebocyte lysate (LAL) assay. Creative BioMart Microbe has established a comprehensive endotoxin testing platform, providing customers with both LAL-based endotoxin testing services and rFC reagent-based endotoxin testing services.
Endotoxin is a pyrogen that can cause severe symptoms such as diarrhea and vomiting in the human body. It may enter the human body through injectable drugs (such as chemicals, radiopharmaceuticals, antibiotics, biological products, etc.) and medical devices(such as dialysate, implantable devices, etc.). Therefore, it is necessary to conduct endotoxin testing for such related products.As an alternative to the LAL assay, the rFC assay has been used for endotoxin testing of such products.
Before the advent of rFC reagents, endotoxin tests used reagents derived from blood cells (amoebocytes) from the horseshoe crab Limulus polyphemus. When tested in vitro with the Limulus reagent, the complete coagulation cascade is shown, but in the factor G-mediated pathway, β-1,3-glucan activates LAL, potentially leading to false-positive results. Factor C is an enzyme in the coagulation cascade, and measuring endotoxin in a sample by directly reacting recombinant factor C with a fluorescent marker can eliminate the interference of β-1,3-glucan on the test results. Therefore, more specific endotoxin detection can be performed by rFC reagents. Biotechnologically engineered mass-produced rFC reagents have high purity and low batch-to-batch specificity, which can further improve the accuracy of endotoxin testing. The rFC method is highly specific and sensitive, with ethical and ecological advantages due to the use of non-animal-derived reagents.
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