SAFENSURE™ Recombinant Factor C Endotoxin Detection Kit

FAB

1. Comparable to LAL method - Endpoint fluorescent assay, comparable to other chromogenic quantitative LAL methods.
2. 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.
3. Accuracy - Traceability of endotoxin standards in the kit against USP Standard (Catalog No: 1235503).
4. Fast time to results - 1 hours.
5. High sensitivity - Sensitivity range from 0.005-5 EU/mL.
6. Extensive validation – Verification on multiplex biological products, kinds of microplate readers and various buffer systems, comprehensive validation of specificity, sensitivity, precision, accuracy, applicability, and other aspects according to the parameters listed in the EUROPEAN PHARMACOPOEIA 11.0 and USP chapter<<1225>>.
7. Sustainable resource - Get rid of dependence on animal derived reagents, reduce dependence on horseshoe crab resources and fishing pressure and realize long-term supply.
8. Good inter batch consistency - Batch consistency of products is guaranteed due to the use of genetic recombination technology for production.

Recombinant C Protein: Saving Horseshoe Crabs for a Greener Future

Product Overview

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.

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.

Materials Provided

Application

1. Raw materials
2. Water testing
3. Intermediate product testing

1. Parenteral drugs & Biological products
2. Infusion, injection or tranfusion cells
3. Cell culture media
4. Medical devices

It is for research use only.

Storage

1. Unopened kit should be stored at 2℃-8℃ upon receiving.

2. Find the expiration date on the outside packaging and do not use reagents past their expiration date.

ACRO Quality Management System

1. QMS(ISO, GMP)
2. Quality Advantages
3. Quality Control Process