Endotoxin Detection Kit (Recombinant Factor C)
Based on 3 publication(s) in Google Scholar
MCE Endotoxin Detection Kit (Recombinant Factor C) is suitable for the detection of endotoxins in therapeutic injectable drugs for human use (such as chemical drugs, antibiotics, and biologics), as well as in medical devices including dialysis fluids and implantable devices. It can be applied throughout raw material screening, process development, manufacturing, and commercialization stages.
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Storage :
4°C, 1 year.
To place orders, for customer services and technical support, please contact: MedChemExpress USA
Tel: 609-228-6898 E-mail: [email protected] [email protected]
Description & Advantages
MCE Endotoxin Detection Kit (Recombinant Factor C) is suitable for the detection of endotoxins in therapeutic injectable drugs for human use (such as chemical drugs, antibiotics, and biologics), as well as in medical devices including dialysis fluids and implantable devices. It can be applied throughout raw material screening, process development, manufacturing, and commercialization stages.
Principle of Detection: This assay utilizes a genetically engineered recombinant Factor C (rFC) protein derived from Tachypleus tridentatus. Upon binding to endotoxins, the rFC is activated and cleaves a fluorogenic substrate, releasing a fluorescent signal. The fluorescence intensity is proportional to the endotoxin concentration, enabling quantitative detection.
Features of MCE Endotoxin Detection Kit (Recombinant Factor C)
1. Endpoint fluorescence measurement, providing quantification performance comparable to other LAL-based methods.
2. High specificity: detects endotoxins exclusively with no interference from Factor G pathways.
3. High sensitivity: detection range of 0.005-5 EU/mL.
4. Recombinant expression ensures good batch-to-batch consistency.
5. Ready-to-use liquid reagents simplify the workflow.
6. Animal component-free formulation enhances supply security.
7. Eliminates reliance on animal-derived reagents, aligning with the 3R principles (Replacement, Reduction, and Refinement).
Protocol
1. Preparation
Keep samples, standards, pipette tips, tubes, and all consumables free of endotoxin contamination. Equilibrate reagents to room temperature and use the supplied sterile pyrogen-free white 96-well plate.
2. Endotoxin standard curve
Reconstitute Endotoxin Standard with Pyrogen-Free Water and prepare serial dilutions. A standard curve may cover the following range:
| Standard | Suggested final concentration (EU/mL) |
|---|---|
| S0 | 0 |
| S1 | 0.005 |
| S2 | 0.05 |
| S3 | 0.5 |
| S4 | 5 |
3. Sample treatment
Dilute samples as required to reduce matrix effects. If the sample matrix masks endotoxin or interferes with the rFC reaction, pretreat with Unmasking Buffer 1 or Unmasking Buffer 2 and include the corresponding sample blank.
4. rFC reaction mixture
Prepare immediately before use at the following reference ratio:
| Component | Reference ratio |
|---|---|
| rFC Enzyme Solution | 1 part |
| Assay Buffer | 4 parts |
| Fluorogenic Substrate Solution | 5 parts |
5. Add standards and test samples to the pyrogen-free white 96-well plate, then add freshly prepared rFC reaction mixture at the volume specified for the assay. Mix gently and avoid bubbles.
6. Incubate at 37°C protected from light and measure fluorescence with a microplate reader. A recommended channel is approximately Ex 380 nm / Em 440 nm.
7. Generate a standard curve from the endotoxin standards, calculate endotoxin concentration in each sample, and correct for the sample dilution factor.
Note: Endotoxin assays are highly sensitive to environmental contamination. Use pyrogen-free consumables and replicate wells for standards and samples.
Publications
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Journal Impact Factor
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Most Recent
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Trends BiotechnolSynthetic M13 phage engagers expand CAR-T cell antigen recognition to overcome tumor heterogeneity. [Abstract]2026 Mar 28:S0167-7799(26)00047-8. PMID: 41904099
Storage
4°C, 1 year.
Attention
1. This product is intended for in vitro endotoxin testing of samples only and must not be used for clinical diagnosis or treatment.
2. All consumables that come into contact with the assay reagents during endotoxin testing must be certified sterile and endotoxin-free to prevent contamination of the reagents.
3. Before use, allow all reagents to equilibrate naturally to room temperature (20-25ºC).
4. Do not mix reagents from different batches.
5. This product is for R&D use only, not for drug, household, or other uses.
6. For your safety and health, please wear a lab coat and disposable gloves to operate.
Components
| Components | HY-K1099-48 T | HY-K1099-96 T |
|---|---|---|
| rFC Enzyme Solution | 0.6 mL | 1.2 mL |
| Assay Buffer | 2.5 mL | 5 mL |
| Fluorogenic Substrate Solution | 3 mL | 6 mL |
| Endotoxin Standard (Lyophilized Powder) | 1 Vial | 1 Vial × 2 |
| Disposable Sterile Pyrogen-Free 96-Well White Plate | 1 ea | 1 ea |
| Unmasking Buffer 1 | 10 mL | 10 mL |
| Unmasking Buffer 2 | 10 mL | 10 mL |
| Pyrogen-Free Water | 30 mL | 30 mL |
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