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产品描述（Product Details）
| Assay Type | Sandwich-ELISA |
| Analyte | EPO |
| Format | 96T |
| Reactivity | Human |
| Regulatory Status | RUO |
| Sensitivity | 0.67 mlU/mL |
| Standard Curve Range | 0.87 mlU/mL-212 mlU/mL |
| Assay Time | 2 hr 45 min |
| Suitable Sample Type | For the quantitative determination of human EPO in Cell Culture Supernatants, Plasma, Serum. |
| Sample volume | 50 uL |
组分（Materials Provided）
| ID | Components | Size |
| CEA027-C01 | Pre-coated Anti-EPO Antibody Microplate | 1 plate |
| CEA027-C02 | Human EPO Standard | 3392 IU×2 |
| CEA027-C03 | Biotin-Anti-EPO Antibody Con. Solution | 100 μL |
| CEA027-C04 | Biotin-Antibody Dilution Buffer | 8 mL |
| CEA027-C05 | Streptavidin-HRP Con. Solution | 500 μL |
| CEA027-C06 | HRP Dilution Buffer | 15 mL |
| CEA027-C07 | 20× Washing Buffer | 50 mL |
| CEA027-C08 | Sample Dilution Buffer | 15 mL×2 |
| CEA027-C09 | Substrate Solution | 12 mL |
| CEA027-C10 | Stop Solution | 6 mL |
背景（Background）
ClinMax? ELISA Kit is convenient ready-to-use immunoassay Kit, specifically designed to quantitate human EPO that is present in complex biological samples, such as human serum, plasma, and cell culture supernates.
A comprehensive validation of the ELISA method was performed following the ICH M10 on bioanalytical method validation and the FDA’s bioanalytical method validation guidance for industry. This validation included assessments of linearity, accuracy, precision, dilution linearity, recovery, and the hook effect. For details information, please refer to the DS.
ClinMax? ELISA Kits are manufactured in a GMP-certified facility and comply to the ISO 13485 standard, ensuring a high level of quality and reliability.
应用说明（Application）
The kit is developed for quantitative detection of human EPO in serum and plasma.
It is for research use only.
重构方法（Reconstitution）
Please see Certificate of Analysis for details of reconstitution instruction and specific concentration.
存储（Storage）
The unopened kit is stable for 12 months from the date of manufacture if stored at 2°C to 8°C.
The opened kit should be stored per components table. The shelf life is 30 days from the date of opening.
原理（Assay Principles）
典型数据-Typical Data Please refer to DS document for The assay protocol.
For each experiment, each ELISA plate needs to set the standard curve. The minimum detectable concentration of EPO is less than 0.67 mIU/mL.
验证（Validation）
精密度（Precision）
To evaluate the intra-assay precision of assay using CEA-C027 and Competitor R, four samples spiked with different concentrations of EPO were tested. Results shown in the following Table. CV values of all analytes are less than 6%. Acceptable criteria : CV<10%.
基质效应（Matrix Effect）
To evaluate the hemolysis matrix effect and high-dose triglyceride matrix effect of assay, serum samples spiked with high concentrations of hemoglobin (2%), or triglyceride (3 mg/mL) were tested. Results shown that all spiked analytes had recoveries between 90% and 110%, no hemolysis matrix effect and high-dose triglyceride matrix effect was observed in assay using CEA-C027.
钩状效应（Hook Effect）
To evaluate the hook effect of the assay, some samples with high concentration of EPO were tested. Results shown in the following figure. No hook effect was found in the assay using the CEA-C027.
稀释线性（Dilution Linearity）
To evaluate the linearity of assay using CEA-C027 and Competitor R, samples (Serum, EDTA plasma) spiked with high concentrations of EPO were serially diluted with dilution buffer to produce samples with values within the dynamic range of the assay. Results shown that recoveries of all analytes are less than 120%. Acceptable criteria: Recovery should be between 80% and 120%.
回收率（Recovery）
To evaluate the recovery of assay using CEA-C027 and Competitor R, samples (Serum, EDTA plasma) spiked with low concentrations of EPO (LQC) were tested. All analytes had recoveries between 80% and 100%. Acceptable criteria: Recovery should be between 80% and 120%.
一致性（Consistency）
To evaluate the consistency of assay using CEA-C027 and Competitor R, 40 healthy serum samples and 14 patient serum samples were tested, and these results demonstrated a high degree of consistency between the two products, R? >0.95.
背景（Background）：EPO
Erythropoietin, EPO
Erythropoietin (EPO) is a glycoprotein hormone, naturally produced by the peritubular cells of the kidney, that stimulates red blood cell production. Renal cortex peritubular cells produce most EPO in the human body. PO2 directly regulates EPO production. The lower the pO2, the greater the production of EPO. Erythropoietin stimulating agents (ESAs) are recombinant versions of EPO produced pharmacologically. Examples of ESAs are epoetin, darbepoetin, and methoxy polyethylene glycol-epoetin beta. ESAs are generally indicated in conditions where there is impaired red blood cell production. This activity will highlight the mechanism of action, adverse event profile, pharmacology, monitoring, and relevant interactions of ESAs in light of the natural physiology of erythropoietin, pertinent for members of the interprofessional team in the treatment of patients with conditions where these agents are indicated.
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