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产品描述（Product Details）
| Assay Type | Sandwich-ELISA |
| Analyte | IFN-γ |
| Format | 96T |
| Reactivity | Human |
| Regulatory Status | RUO |
| Sensitivity | <4.0 pg/mL |
| Standard Curve Range | 7.18 pg/mL-1000 pg/mL |
| Assay Time | 2 hr |
| Suitable Sample Type | For the quantitative determination of human IFN-γ in Plasma and Serum. |
| Sample volume | 50 μL |
组分（Materials Provided）
| ID | Components | Size |
| CEA006-C01 | Pre-coated Anti-IFN-γ Antibody Microplate | 1 plate |
| CEA006-C02 | IFN-γ Calibrator | 15 μg×2 |
| CEA006-C03 | Biotin-Anti-IFN-γ Antibody Concentrated Solution | 100 μL |
| CEA006-C04 | Biotin Antibody Dilution Buffer | 8 mL |
| CEA006-C05 | IFN-γ Streptavidin-HRP Concentrated Solution | 0.5 mL |
| CEA006-C06 | Streptavidin-HRP Dilution Buffer | 15 mL |
| CEA006-C07 | 20× Washing Buffer | 50 mL |
| CEA006-C08 | Sample Dilution Buffer | 15 mL×2 |
| CEA006-C09 | Substrate Solution | 12 mL |
| CEA006-C10 | Stop Solution | 6 mL |
背景（Background）
ClinMax? ELISA Kit is convenient ready-to-use immunoassay Kit, specifically designed to quantitate human IFN-gamma 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）
Results are obtained by Log-Log Linear regression equation are used to draw the standard curve and calculate the sample concentration. The verification results indicate that this kit can be used for the quantitative determination of natural and recombinant human IFN-γ concentrations.
It has been calibrated against a highly purified human IFN-γ and is evaluated with standard from NIBSC/WHO. Reference Reagent INTERFERON GAMMA (Human, rDNA derived) NIBSC code: 87/586.
It is for research use only.
存储（Storage）
The unopened kit is stable for 12 months from the date of manufacture if stored at 2°C to 8°C.
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, each ELISA plate needs to set the standard curve. The minimum detectable concentration of CEA-C006 is less than 4.0 pg/mL.
验证（Validation）
稀释线性（Dilution Linearity）
Three human serum samples with high concentrations of IFN-γ were diluted 1:2, 1:4, 1:8, 1:16, 1:32, 1:64 with Dilution Buffer to produce samples with values within the dynamic range and then assayed. On average, 99.58% of IFN-γ was detected from serum samples.
批内差异（Intra-Assay Statistics）
Ten replicates of each of five samples containing different IFN-γ concentrations were tested in one assay, Intra-Assay Precision CV<10%.
批间差异（Inter-Assay Statistics）
Five samples containing different concentrations of IFN-γ were tested in three independent assays, Inter-Assay Precision CV<15%.
回收率（Recovery）
Recombinant IFN-γ（8000，6000，4000pg/mL）was spiked into 5 human serum samples, and then analyzed. On average, 98.28% of IFN-γ was recovered from serum samples.
干扰效应(Interference effect)
Bilirubin (simulated jaundice) concentration should be less than 20mg/dL, hemoglobin (simulated hemolysis) concentration should not be higher than 3500mg/dL, triglyceride (simulated lipemia) concentration may not be higher than 2.0g/L，EDTA concentration should be less than 4mg/mL, and Sodium citrate concentration may not be higher than 40mg/mL，it does not affect the detection result.
背景（Background）：IFN-gamma
Interferon-γ, IFN-γ, Interferon Gamma
Interferon-γ is produced mainly by activated T cells and NK cells. It is a proinflammatory cytokine that activates macrophages and endothelial cells, but it also regulates immune responses by effecting APC and T and B cells. Production of IFN-γ by helper T cells as well as cytotoxic T cells is a hallmark of the TH1-type phenotype, thus, high-level production of IFN-γ is typically associated with effective host defense against intracellular pathogens.
IFN-γ is capable of orchestrating numerous protective functions to heighten immune responses in infections and cancers. It can exhibit its immunomodulatory effects by enhancing antigen processing and presentation, increasing leukocyte trafficking, inducing an anti-viral state, boosting the anti-microbial functions and affecting cellular proliferation and apoptosis.
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