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产品概述（Product Details）
ClinMax™ Human TNF-αlpha Quick ELISA Kit is a ready-to-use immunoassay kit, specifically designed to quantitate natural and recombinant human TNF-alpha 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 TNF-alpha in serum, plasma and cell culture supernatants.
It is suitable for potency assay of mAbs.
This Assay has been anchored to NlBSC/WHO standards (Code: 12/154), ClinMax ELISA Kit: NIBSC/WHO Mass Conversion Factor is 1.
It is for research use only.
流程图（Workflow）
关键信息（Key Features）
Assay TypeSandwich-ELISAAnalyteTNF-αFormat96-wells plate breakable into 12 x 8 wells stripsReactivityHumanSensitivity2pg/mLAssay Time1.75 hrSample volume50 uLRange19.5 pg/mL-1250 pg/mLSample TypeCell Culture Supernatants, Plasma, Serum.NIBSC Code12/154Elevate 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.
组分（Materials Provided）
IDComponentsSizeCEA246-C01Pre-coated Anti-TNF-α Antibody Microplate1 plate(8×12 strips)CEA246-C02Human TNF-α Standard12.5ng×2CEA246-C03Biotin-Anti-TNF-α Antibody20μgCEA246-C04Biotin-Antibody Dilution Buffer8mLCEA246-C05Streptavidin-HRP Con. Solution500μLCEA246-C06Streptavidin-HRP Dilution Buffer15mLCEA246-C0720× Washing Buffer50mLCEA246-C08Sample Dilution Buffer15mL ×2CEA246-C09Substrate Solution12mLCEA246-C10Stop Solution6mL质量管理控制体系（QMS）
数据展示
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 cal-culated based on the results of the standard curve. The minimum detectable con-centration of TNF-α is less than 2.0 pg/mL.
样本值（Sample Values）
Human peripheral blood mononuclear cells (PBMCs) obtained were plated at a density of 1 × 10⁶ cells/mL in complete RPMI 1640 medium containing 10% fetal bovine serum, 2 mM L-glutamine, and antibiotic supplements (penicillin 100 U/mL with streptomycin sulfate 100 μg/mL). Following a 5-day incubation period, experimental groups were either maintained as untreated controls or stimulated with 10 μg/mL phytohemagglutinin (PHA). Subsequent analysis involved quantitative measurement of TNF-alpha concentrations in collected culture supernatants using standardized immunoassays.
批内差异（Intra-Assay Statistics）
Ten replicates of each of 3 samples containing different TNF-α concentrations were tested in one assay. Acceptable criteria: CV＜10%.
批间差异（Inter-Assay Statistics）
3 samples containing different concentrations of TNF-α were tested in inde-pendent assays. Acceptable criteria: CV<15%.
回收率（Recovery）
Recombinant TNF-α was spiked into 3 human serum samples, and then analyzed. The average recovery of TNF-α for serum samples is 91.3%.
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