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Your Position: Home > Kits > EPO > CEA-C027

ClinMax™ Human Erythropoietin (EPO) ELISA Kit, PRO

For research use only.

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Product Details
Assay TypeSandwich-ELISA
AnalyteEPO
Format96T
ReactivityHuman
Sensitivity0.67 mlU/mL
Standard Curve Range0.87 mlU/mL-212 mlU/mL
Assay Time2 hr 45 min
Suitable Sample TypeFor the quantitative determination of human EPO in Cell Culture Supernatants, Plasma, Serum.
Sample volume50 uL
Materials Provided
IDComponentsSize
CEA027-C01Pre-coated Anti-EPO Antibody Microplate1 plate
CEA027-C02Human EPO Standard3392 IU×2
CEA027-C03Biotin-Anti-EPO Antibody Con. Solution100 μL
CEA027-C04Biotin-Antibody Dilution Buffer8 mL
CEA027-C05Streptavidin-HRP Con. Solution500 μL
CEA027-C06HRP Dilution Buffer15 mL
CEA027-C0720× Washing Buffer50 mL
CEA027-C08Sample Dilution Buffer15 mL×2
CEA027-C09Substrate Solution12 mL
CEA027-C10Stop Solution6 mL
  • 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.

  • Application

    The kit is developed for quantitative detection of human EPO in serum and plasma.

    It is for research use only.

  • Reconstitution
    Please see Certificate of Analysis for details of reconstitution instruction and specific concentration.
  • Storage
    Keep the unopened kit stored at 2-8 °C. Avoid using the kit beyond its expiration date. The opened kit should be stored per components table. The shelf life is 30 days from the date of opening.
  • Assay Principles
     EPO Assay Principles
Typical Data Please refer to DS document for the assay protocol.
 EPO TYPICAL DATA

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.

Validation
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%.

 EPO PRECISION
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.

 EPO MATRIX EFFECT
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.

 EPO HOOK EFFECT
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%.

 EPO DILUTION LINEARITY
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%.

 EPO RECOVERY
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, R² >0.95.

 EPO CONSISTENCY
  • 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.
  • Clinical and Translational Updates

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