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| Assay Type | Sandwich-ELISA |
| Analyte | EGF |
| Format | 96T |
| Reactivity | Human |
| Sensitivity | <35pg/mL |
| Standard Curve Range | 62.5 pg/mL-8000 pg/mL |
| Assay Time | 2 hr 45 min |
| Suitable Sample Type | For the quantitative determination of human EGF in Cell Culture Supernatants, Plasma, Serum. |
| Sample volume | 50 uL |
| ID | Components | Size |
| CEA080-C01 | Pre-coated Anti-EGF Antibody Microplate | 1 plate |
| CEA080-C02 | Human EGF Standard | 7.5 ug×2 |
| CEA080-C03 | Biotin-Anti-EGF Antibody Con. Solution | 100 μL |
| CEA080-C04 | Biotin-Antibody Dilution Buffer | 8 mL |
| CEA080-C05 | Streptavidin-HRP Con. Solution | 500 μL |
| CEA080-C06 | Streptavidin-HRP Dilution Buffer | 15 mL |
| CEA080-C07 | 20× Washing Buffer | 50 mL |
| CEA080-C08 | Sample Dilution Buffer | 15 mL×2 |
| CEA080-C09 | Substrate Solution | 12 mL |
| CEA080-C10 | Stop Solution | 6 mL |
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-like facility and comply to the ISO 13485 standard, ensuring a high level of quality and reliability.
The kit is developed for quantitative detection of human EGF in serum, plasma and cell culture supernates.
It is for research use only.
For each experiment, a standard curve needs to be set for each microplate, and the specific OD value may vary depending on different laboratories, testers, or equipment. The following example data is for reference only. The sample concentration was calculated based on the results of the standard curve. The minimum detectable concentration of EGF is less than 35 pg/mL.
Ten replicates of each of 3 samples containing different EGF concentrations were tested in one assay. Acceptable criteria: CV＜10%.
Three samples containing different concentrations of EGF were tested in independent assays. Acceptable criteria: CV<15%.
Recombinant EGF was spiked into 3 human serum samples, and then analyzed. The average recovery of EGF for serum samples is 105%.
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