产品概述(Product Details)
ClinMax™ Human Insulin ELISA Kit is a ready-to-use immunoassay kit, specifically designed to quantitate natural and recombinant human insulin 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 insulin in serum, plasma and cell culture supernatants.
It is for research use only.
流程图(Workflow)
关键信息(Key Features)
Analyte | Insulin |
Assay Type | Sandwich-ELISA |
Reactivity | Human |
Sensitivity | 4.69 μIU/mL |
Range | 4.69 μIU/mL-300 μIU/mL |
Assay Time | 1.75 hr |
Sample Type | Cell Culture Supernatants, Plasma, Serum. |
Sample volume | 50 uL |
Format | 96-wells plate breakable into 12 x 8 wells strips |
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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 Insulin is less than 4.69 μIU/mL.
验证(Validation)
样本值(Sample Values)
Serum – Insulin concentrations were measured in 32 human serum samples, which were collected from healthy human subjects. The measurements of 32 samples are shown in the figure below.
稀释线性(Dilution Linearity)
High concentrations of human Insulin serum samples were diluted with 1:2, 1:4, 1:8, 1:16 ratios for gradient dilution to evaluate the linearity of the assay. In the serum samples, the average detection rate of Insulin was 107.8%.
批内差异(Intra-Assay Statistics)
10 replicates of each of 4 samples containing different Insulin concentrations were tested in one assay. Acceptable criteria: CV<10%.
批间差异(Inter-Assay Statistics)
4 samples containing different concentrations of Insulin were tested in the independent assays. Acceptable criteria: CV<15%.
回收率(Recovery)
Insulin was spiked into 3 human serum samples, and then analyzed. The average recovery of Insulin for serum samples is 103.8%.
组分(Materials Provided)
ID | Components | Size |
CEA205-C01 | Pre-coated Anti-Insulin Antibody Microplate | 1 plate |
CEA205-C02 | Human Insulin Standard (Std.-1) | 300 μIU/mL |
CEA205-C03 | Biotin-Anti-Insulin Antibody Con. Solution | 400 μL |
CEA205-C04 | Biotin-Antibody Dilution Buffer | 8 mL |
CEA205-C05 | Streptavidin-HRP Con. Solution | 500 μL |
CEA205-C06 | Streptavidin-HRP Dilution Buffer | 15 mL |
CEA205-C07 | 20× Washing Buffer | 50 mL |
CEA205-C08 | Sample Dilution Buffer | 15 mL×2 |
CEA205-C09 | Substrate Solution | 12 mL |
CEA205-C10 | Stop Solution | 6 mL |