膜杰作
Star Staining
- 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.
- Accuracy - Traceability of endotoxin standards in the kit against USP Standard (Catalog No: 1235503).
- Fast time to results - 1 hours.
- High sensitivity - Sensitivity range from 0.005-5 EU/mL.
- 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.
- Sustainable resource - Get rid of dependence on animal derived reagents, reduce dependence on horseshoe crab resources and fishing pressure and realize long-term supply.
- Good inter batch consistency - Batch consistency of products is guaranteed due to the use of genetic recombination technology for production.
产品描述（Product Details）
| Assay Type | FRET |
| Analyte | Endotoxin |
| Format | 96T |
| Regulatory Status | RUO |
| Sensitivity | 0.005 EU/mL |
| Standard Curve Range | 0.005 EU/mL-5 EU/mL |
| Assay Time | 1 hr |
| Suitable Sample Type | For the quantitative determination of endotoxin from pharmaceutical products, biologicals for injection and some media for tissue cultures. |
| Sample volume | 100 μL |
背景（Background）
Endotoxins, also called lipopolysaccharides (LPS), are the component of the outer membrane of gram-negative bacteria and are released into the surrounding environment upon disruption of the intact bacteria (death, cell lysis). Endotoxin is known to cause reactions in animals with symptoms of high fever, vasodilation, diarrhea, and in extreme cases, fatal shock. In vivo, it may lead to the complications mentioned above, while in vitro, the presence of this contaminant may affect the results and compromise the conclusions. Therefore, it is essential to develop sensitive, accurate, and rapid methods for its detection.
The Limulus Amoebocyte Lysate test (LAL) has been widely used for decades for the detection of endotoxin in the quality assurance of injectable drugs and medical devices. Limuluspolyphemus, existing in the blood of horseshoe crabs, can form a clot when exposed to LPS. Based on this unique property, the LAL test has been developed. However, as an in vitro endotoxin detection tool, variations in the sensitivity and specificity of LAL to endotoxin, and the dwindling supply of horseshoe crabs are posing increasing challenges to the biotechnology industry. To address these challenges, a recombinant factor C (rFC) assay was developed as an alternative to LAL.
应用说明（Application）
The Recombinant Factor C Endotoxin Detection Kit is a non-animal-derived complete kit for in vitro end-product endotoxin quantitative determination of parenteral drugs, biological products, infusion cells, medical devices and some media for tissue cultures.
The kit is for research and manufacturing use only, it is not intended for clinical diagnostic use in humans or animals or for the qualification of blood or blood products.
It is for research use only.
存储（Storage）
Unopened kit should be stored at 2°C-8°C upon receiving.
Find the expiration date on the outside packaging and do not use reagents past their expiration date.
组分（Materials Provided）
| ID | Components | Size |
| RES056-C01 | Bacterial Endotoxin Standard | 1 vial |
| RES056-C02 | Recombinant Factor C Protein | 96 tests |
| RES056-C03 | Fluorogenic Substrate | 96 tests |
| RES056-C04 | Water for Bacterial Endotoxins Test | 50 mL |
原理（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.
