| Assay Type | Sandwich-ELISA |
| Format | 96T |
| Analyte | EPO |
| 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 |
| 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 |
ClinMax product are manufactured in a dedicated GMP facility and are compliant with our ISO 13485 quality management system.
The verification scheme was designed in accordance with the 9012 "Guidelines for the Verification of Quantitative Analysis Methods of Biological Samples" in the Chinese Pharmacopoeia 2020 Edition and the ICH M10 Guideline. Sensitivity, specificity, precision, recovery, and linearity were verified for multi-batch products and multiple concentration samples. See manual for more information on validation in DS.
The kit is developed for quantitative detection of human EPO in serum and plasma.
It is for research use only.
The opened kit should be stored per components table. The shelf life is 30 days from the date of opening.
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.
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%.
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.
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.
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%.
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%.
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, R² >0.95.
Please contact us via TechSupport@acrobiosystems.com if you have any question on this product.
Price(USD) : $549.00
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