Product Overview

Endotoxin is a component of the cell wall of Gram-negative bacteria and endotoxins are abundantly present in the environment. When a large amount of endotoxin enters the bloodstream, it may cause severe symp- toms such as fever, even shock and DIC. Therefore according to regulatory guidance worldwide, for drugs and medical devices that are prone to introducing endotoxins into human body, endotoxin detection must be carried out.
Recombinant Factor C Endotoxin Detection Kit is a sustainable alternative for endotoxin detection which has the advantages of strong specificity, high sensitivity, and simple operation. Compared with traditional Limulus Amoebocyte Lysate(LAL) based endotoxin detection method, the recombinant factor C detection method reduces the dependence on horseshoe crab blood and is more inline with sustainable and ethical requirements.
The horseshoe crab is an ancient marine creature and its unique blue blood is widely used in the medical field for endotoxin detection. However, the current status of horseshoe crab resources is not optimistic. Due to the influence of human activities, such as overfishing and habitat destruction, the number of horseshoe crabs has decreased sharply. This has brought challenges to the method of endotoxin detection that relies on horseshoe crab blood. To protect horseshoe crab resources, researchers are committed to developing alternative methods, such as the recombinant factor C detection method. These new methods not only can reduce the dependence on horseshoe crabs, but also have some advantages, such as higher specificity and sensitivity, and more convenient operation. In the future, while ensuring the accuracy and efficiency of endotoxin detection, we need to pay more attetion to the protection and sustainable utilization of horse- shoe crab resources.

The principle of endotoxin detection by recombinant C factor is based on the specific reaction between endotoxin and recombinant C factor. Endotoxin can activate the recombinant C factor and initiate an enzymatic cascade reaction. Specifically, the activated recombinant C factor will cleave specificsubstrates, generating detectable fluorescent or chromogenic signals. By measuring the intensity of this signal, the endotoxin content in the sample can be quantitatively analyzed.

Product Application

Generally, all drugs and biological products that enter the human body through injection and are prone to introducing endotoxins need to undergo bacterial endotoxin testing to ensure their safety and effective-ness.

① Pharmaceutical products: injections, vaccines, blood products, and serum

- Injections: including various types of chemical drug injections, antibody drug injections and traditional Chinese medicine injections.

- Vaccines: including various types of inactivated vaccine, Atienuated live vaccine, Subunit vaccine, Nucleic acid vaccine(in-cluding DNA vaccine and RNA vaccine), Conjugate vaccine, etc. 

- Blood products: such as human albumin, immunoglobulin, etc.

- Life science: Endotoxin detection of proteins, plasmids and other molecular biology products.
- QC testing: multi-point monitoring of intermediate products in pharmaceutical enterprises, quality control of final products, and pre- and post-verification and daily monitoring of water for injection.

② Medical Devices: eg. Endotoxin test for blood transfusion, infusion and implantable medical devices.

Advantages Highlight

- Sustainable and environment friendly: does not depend on animal-derived components
- High consistency with LAL method
- Excellent Adaptability:
• Standard Curve: R 2> 0.999
• Linear Range: 0.005-5 EU/mL
• High accuracy and Repeatability: intra batch CV <10%; inter-batch CV<15%
• Spike Recovery: 50%-200%
- High Specificity: no interference from the G factor collateral pathway andsuitable for endotoxin detection in samples with β - glucan interference
- Good stability: Endotoxin standard can be stored at 4℃ for 8 weeks atier dissolution

Performance Data

① Good Systematic adaptability:

Note: %PPC (Positive Product Control) recovery should be 50% to 200% of the added spike value for photo-metric techniques and PPC must clot in gel clot methods

② High consistency with LAL method: Comparison of endotoxin test values in actual samples

③ High accuracy and Repeatability: intra batch CV <10%; inter-batch CV<15%.

④ High Specificity: no interference from the G factor collateral pathway and suitable for endotoxin detec-tion in samples with β - glucan interference

⑤ Good stability: Endotoxin standard can be stored at 4℃ for 8 weeks after dissolution