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ClinMax
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产品描述（Product Details）
| Assay Type | Sandwich-ELISA |
| Analyte | IL-1β |
| Format | 96T |
| Reactivity | Human |
| Regulatory Status | RUO |
| Sensitivity | <1.0 pg/mL |
| Standard Curve Range | 4.69 pg/mL-600 pg/mL |
| Assay Time | 2 hr |
| Suitable Sample Type | For the quantitative determination of human IL-1β in Plasma and Serum. |
| Sample volume | 50 μL |
组分（Materials Provided）
| ID | Components | Size |
| CEA002-C01 | Pre-coated Anti-IL-1β Ab Microplate | 1 plate |
| CEA002-C02 | IL-1β Calibrator | 20 μg×2 |
| CEA002-C03 | Biotin-Anti-IL-1β Ab Con. Solution | 100 μL |
| CEA002-C04 | Biotin-Ab Dilution Buffer | 8 mL |
| CEA002-C05 | IL-1β SA-HRP Con. Solution | 0.5 mL |
| CEA002-C06 | SA-HRP Dilution Buffer | 15 mL |
| CEA002-C07 | 20× Washing Buffer | 50 mL |
| CEA002-C08 | Sample Dilution Buffer | 15 mL×2 |
| CEA002-C09 | Substrate Solution | 12 mL |
| CEA002-C10 | Stop Solution | 6 mL |
背景（Background）
ClinMax™ Human IL-1β Quantitative ELISA Kit is a one-step quick immunoassay designed to quantitate human IL-1β that is present in complex biological matrices, such as human serum, plasma, buffered solution. This assay kit is a standard sandwich-ELISA format.
ClinMax product are manufactured in a dedicated GMP facility and are compliant with our ISO 13485 quality management system.
The verification scheme was designed in accordance with the 9012 "Guidelines for the Verification of Quantitative Analysis Methods of Biological Samples" in the Chinese Pharmacopoeia 2020 Edition and the ICH M10 Guideline. Sensitivity, specificity, precision, recovery, and linearity were verified for multi-batch products and multiple concentration samples. See manual for more information on validation in DS.
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 IL-1β concentrations.
It has been calibrated against a highly purified human IL-1β and is evaluated with standard from NIBSC/WHO. Reference Reagent Interleukin-1β (Human, rDNA derived) NIBSC code: 86/680.
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-C002 is less than 1.0 pg/mL.
验证（Validation）
稀释线性（Dilution Linearity）
Three human serum samples with high concentrations of IL-1β were diluted 1:2, 1:4, 1:8, 1:16 with Dilution Buffer to produce samples with values within the dynamic range and then assayed. On average, 101.86% of IL-1β was detected from serum samples.
批内差异（Intra-Assay Statistics）
Ten replicates of each of five samples containing different IL-1β concentrations were tested in one assay , Intra-Assay Precision CV＜10%.
批间差异（Inter-Assay Statistics）
Five samples containing different concentrations of IL-1β were tested in three independent assays , Inter-Assay Precision CV<15%.
回收率（Recovery）
Recombinant IL-1β was spiked into 5 human serum samples, and then analyzed. On average, 98.71% of IL-1β was recovered from serum samples.
Recombinant IL-1β was spiked into cell supernatant sample, and then analyzed. On average, 99.57% of IL-1β 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, Heparin concentration should be less than 40U/mL, 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）：IL-1 beta
Interleukin-1β, IL-1β
IL-1β is a potent pro-inflammatory cytokine. IL-1β is produced and secreted by various cell types, such as immune cells, fibroblasts, or cancer cells. The IL-1β gene is induced after "priming" of the cells and a second signal is required to allow IL-1β maturation by inflammasome-activated caspase-1. IL-1β is then released and leads to transcription of target genes through its ligation with IL-1R1 on target cells. IL-1β expression and maturation are guided by gene polymorphisms and by the cellular context. In cancer, IL-1β has pleiotropic effects on immune cells, angiogenesis, cancer cell proliferation, migration, and metastasis.
