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产品描述（Product Details）
| 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 |
组分（Materials Provided）
| 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 |
背景（Background）
ClinMax? ELISA Kit is convenient ready-to-use immunoassay Kit, specifically designed to quantitate human GDF-15 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）
he kit is developed for quantitative detection of human GDF-15 in serum, plasma and cell culture supernates.
It is for research use only.
存储（Storage）
Unopened kit should be stored at 2℃-8℃ upon receiving. 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, 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.
验证（Validation）
批内差异（Intra-Assay Statistics）
Ten replicates of each of 3 samples containing different GDF-15 concentrations were tested in one assay. Acceptable criteria: CV＜10%.
批间差异（Inter-Assay Statistics）
Three samples containing different concentrations of Soluble Mesothelin were tested in independent assays. Acceptable criteria: CV<15%.
回收率（Recovery）
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%.
背景（Background）：GDF-15
Growth/differentiation factor 15 is a protein that in humans is encoded by the GDF15 gene. GDF15 was first identified as Macrophage inhibitory cytokine-1 or MIC-1.
It is a protein belonging to the transforming growth factor beta superfamily. Under normal conditions, GDF15 is expressed in low concentrations in most organs and upregulated because of injury of organs such as liver, kidney, heart and lung.
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