Recombinant Factor C Endotoxin Detection Kit

Product Description

• Comparable to LAL method - Endpoint fluorescent assay, comparable to other chromogenic quantitative LAL methods
• High specificity - Unlike LAL Assay, as Factor G is absent from the rFC test kit, false-positive results due to β-glucan activation are not expected to occur
• Fast - Results in 1 hour
• High sensitivity - Sensitivity range from 0.005-5 EU/mL
• Animal-free

Assay Principles

The Recombinant Factor C Endotoxin Detection Kit is a novel endotoxin detection method based on the recombination technology. Recombinant Factor C, as the first component of the horseshoe crab coagulation cascade reaction, is activated by an endotoxin. The activated Factor C can cleave the fluorogenic substrate and produce a fluorescent signal. The increase of fluorescence signal is positively correlated with the dosage of endotoxin. The experiment is carried on a white 96-well plate and is measured at time zero and after a one-hour 37℃ incubation. Use a fluorescence microplate reader to measure at the wavelength of ex/em = 380/440 nm to determine whether the sample is contaminated by endotoxin.

Application

• Production process (Process control)
  - Raw materials
  - Water testing
  - Intermediate product testing
• Final product (Release testing)
  - Parenteral drugs & Biological products
  - Infusion, injection or tranfusion cells
  - Cell culture media
  - Medical devices

For research use only!

Supporting Data

Bioactivity-Fluorescence

Please refer to the assay protocol

Fig.1: Take the logarithm of the concentration of the Endotoxin working standard solution as the abscissa, take the ΔRFU as the ordinate. Fitting the standard curve with linearly model, and the correlation coefficient R should be ≥ 0.98 (QC tested).

Fig.2: The rFC method was employed to detect endotoxin residues in β-glucan at concentrations of 10ug/mL and 1ug/mL. No non-specific signals were detected. In contrast, the dynamic chromogenic method used for β-glucan detection resulted in the detection of endotoxin and non-specific signals. This indicates that recombinant factor C does not react with β-glucan, demonstrating the good specificity of the rFC method.