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| Assay Type | Sandwich-ELISA |
| Analyte | GDF-15 |
| Format | 96T |
| Reactivity | Human |
| Regulatory Status | PRO |
| Sensitivity | 7.0pg/mL |
| Standard Curve Range | 11.72 pg/mL-1500 pg/mL |
| Assay Time | 2hr |
| Suitable Sample Type | For the quantitative determination of human GDF-15 in Cell Culture Supernatants, Plasma, Serum. |
| Sample volume | 50 μL |
| ID | Components | Size |
| CEA077-C01 | Pre-coated Anti-GDF-15 Antibody Microplate | 1 plate |
| CEA077-C02 | Human GDF-15 Standard | 20 μg×2 |
| CEA077-C03 | Biotin-Anti-GDF-15 Antibody Con. Solution | 200 μL |
| CEA077-C04 | Biotin-Antibody Dilution Buffer | 8 mL |
| CEA077-C05 | Streptavidin-HRP Con. Solution | 500 μL |
| CEA077-C06 | Streptavidin-HRP Dilution Buffer | 15 mL |
| CEA077-C07 | 20× Washing Buffer | 50 mL |
| CEA077-C08 | 2× Sample Dilution Buffer | 15 mL ×2 |
| CEA077-C09 | Substrate Solution | 12 mL |
| CEA077-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-certified facility and comply to the ISO 13485 standard, ensuring a high level of quality and reliability.
he kit is developed for quantitative detection of human GDF-15 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 GDF-15 is less than 7 pg/mL.
Ten replicates of each of 3 samples containing different GDF-15 concentrations were tested in one assay. Acceptable criteria: CV＜10%.
Three samples containing different concentrations of Soluble Mesothelin were tested in independent assays. Acceptable criteria: CV<15%.
Recombinant Soluble Mesothelin was spiked into 5 human serum samples, and then analyzed. The average recovery of GDF-15 for serum samples is 112.19%.
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