Recombinant Factor C (rFC) assay is a widely used method for detecting bacterial endotoxins, also known as lipopolysaccharides (LPS), Endotoxins are a component of the outer membrane of Gram-negative bacteria that can cause a strong inflammatory response in animals, including humans. The rFC assay is based on the use of a genetically engineered form of Factor C, an enzyme that is naturally found in horseshoe crab blood and is involved in the clotting pathway. In the rFC assay, the recombinant Factor C is used to detect the presence of endotoxins by measuring By measuring the content of cleaved substrates in the presence of endotoxin. Compared to traditional methods of endotoxin detection, such as the Limulus Amebocyte Lysate (LAL) assay which uses horseshoe crab blood, the rFC assay is considered to be more standardized and reproducible, as it does not rely on the use of animal-derived reagents. The rFC assay is also more environmentally friendly and sustainable, as it reduces the need for the collection and use of horseshoe crabs in endotoxin detection.
The rFC assay is approved by regulatory authorities, such as the United States Pharmacopeia (USP) , the European Pharmacopoeia (EP) and Chinese Pharmacopoeia (CP) for use in the quality control testing of pharmaceuticals and medical devices.
The advantages of recombinant factor c assay
The Recombinant Factor C (rFC) assay offers several advantages over traditional methods for detecting endotoxins, such as the Limulus Amebocyte Lysate (LAL) assay. Some of the advantages of the rFC assay include:
1. Standardization: The rFC assay is a recombinant DNA technology that uses a single, defined protein as the detection reagent. This makes the assay more standardized and less prone to variability compared to the LAL assay, which relies on the use of a complex mixture of proteins extracted from horseshoe crab blood.
2. Reproducibility: The rFC assay has high levels of reproducibility, as it uses a single, defined protein as the detection reagent. This allows for consistent results, even across different batches and lots of reagents.
3. Reduced animal usage: The rFC assay is a more environmentally friendly and sustainable method for detecting endotoxins, as it does not require the use of live or sacrificed animals, such as horseshoe crabs.
4. Cost-effective: The rFC assay is generally more cost-effective than the LAL assay, due to the reduced need for live animals and the more standardized nature of the assay.
5. Stability: The rFC assay is robust and can be used in a wide range of applications, including quality control testing of pharmaceuticals, medical devices, and other products that may contain endotoxins.
6. Regulatory approval: The rFC assay has been approved by regulatory authorities such as the United States Pharmacopeia (USP) , the European Pharmacopoeia (EP) and Chinese Pharmacopoeia (CP) for use in the quality control testing of pharmaceuticals and medical devices. This provides a high level of confidence in the reliability and accuracy of the assay.
To meet the variety of demand, Bioendo also produces and provides traditional method of gel clot endotoxin test assay kit, rapid gel clot assay kit, quantitative endotoxin test assay kit including “ kinetic turbidimetric endotoxin test assay kit and kinetic chromogenic endotoxin test assay kit ” .
Post time: Feb-19-2023
