膜杰作
Star Staining
产品概述（Product Details）
ClinMax™ Human IFN-γ ELISA Kit, PRO is a ready-to-use immunoassay kit, specifically designed to quantitate natural and recombinant human IFN-gamma that is present in biological samples, such as human serum, plasma, and cell culture supernatants. Our ClinMax™ ELISA Kit provides several benefits:
- Standards to calibrate with NIBSC/WHO standards for comparable results.
- Fully validation in biologic samples for detection range, sensitivity, inter- and intra-plate CV, recovery, dilution linearity, specificity, and matrix effects to ensure reliable results according to ICH M10 guideline.
- High-quality antibody pairs and protein standards, along with rigorous quality control, to guarantee consistent results across different batches.
- Simplified and straightforward protocols and ready-to-use reagents to save assay time.
应用说明（Application）
The kit is developed for quantitative detection of natural and recombinant human IFN-gamma in serum, plasma and cell culture supernatants.
It is suitable for potency assay of CAR-T/NK cell therapy. 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: 82/587.
It is for research use only.
流程图（Workflow）
关键信息（Key Features）
| Analyte | IFN-γ |
| Assay Type | Sandwich-ELISA |
| Reactivity | Human |
| Sensitivity | 4pg/mL |
| Range | 7.81 pg/mL-1000 pg/mL |
| Assay Time | 2 hr |
| Sample Type | Cell Culture Supernatants, Plasma, Serum. |
| Sample volume | 50 uL |
| Format | 96-wells plate breakable into 12 x 8 wells strips |
Elevate your research experience with our Cytokine/Biomarker Detection Kits, where accuracy, reliability, and ease of use are converging to deliver exceptional results.
存储（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.
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 IFN-γ is less than 4.0 pg/mL.
验证（Validation）
样本值（Sample Values）
Serum - IFN-γ concentrations were measured in 208 human serum samples, which were collected from healthy human subjects. The measurements of 208 samples are shown in the figure below.
基质效应（Matrix Effect）
3 types of materials were tested to observe if there were matrix effect (interference). If the concentration of hemoglobin (simulated hemolysis) is less than 3500 mg/dL, the concentration of triglyceride (simulated lipid blood) is less than 3.0 mg/mL, and the concentration of bilirubin (simulated jaundice) is less than 20 mg/dL, testing results will not be affected.
钩状效应（Hook Effect）
According to the hook effect evaluation, tested results will not be affected when IFN-γ concentration is higher than 250 ng/mL.
稀释线性（Dilution Linearity）
High concentrations of human IFN-γ serum samples were diluted with 1:2, 1:4, 1:8, 1:16, 1:32 and 1:64 ratios for gradient dilution to evaluate the linearity of the assay. In the serum samples, the average detection rate of IFN-γ was 99.16%.
批内差异（Intra-Assay Statistics）
10 replicates of each of 4 samples containing different IFN-γ concentrations were tested in one assay. Acceptable criteria: CV＜10%.
批间差异（Inter-Assay Statistics）
4 samples containing different concentrations of IFN-γ were tested in the independent assays. Acceptable criteria: CV<15%.
回收率（Recovery）
IFN-γ was spiked into 5 human serum samples, and then analyzed. The average recovery of IFN-γ for serum samples is 95.92%.
组分（Materials Provided）
| ID | Components | Size |
| CEA006-C01 | Pre-coated Anti-IFN-γ Antibody Microplate | 1 plate |
| CEA006-C02 | Human IFN-γ Standard | 14 μg×2 |
| CEA006-C03 | Biotin-Anti-IFN-γ Antibody Con. Solution | 150 μL |
| CEA006-C04 | Biotin-Antibody Dilution Buffer | 8 mL |
| CEA006-C05 | Streptavidin-HRP Con. Solution | 500 μL |
| 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 |
