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Product Specifications
Assay TypeSandwich-ELISAAnalyteTNF-αFormat96T (8×12 strips)ReactivityHumanRegulatory StatusRUOSensitivity< 6.25 pg/mLStandard Curve Range6.25-400 pg/mLAssay Time2 hr 50 minSuitable Sample TypeFor the quantitative determination of human TNF-α in Cell Culture Supernatants, Plasma, Serum.Sample volume100 μLProduct Overview
Human Tumor Necrosis Factor Alpha (TNF-α) ELISA Kit (Residue Testing) is based on the ELISA sandwich method and is used to detect and quantitatively determine GMP human TNF-α residues in cell culture supernatants, serum, and plasma. The kit contains GMP human Tumor Necrosis Factor Alpha (TNF-α) (ACROBiosystems, cat# GMP-TNAH23) to ensure accurate assay results and is designed to provide a reliable solution for CAR-T product quality assessment during drug development and CMC quality control stages. It can also be used as a universal detection tool for the quantitative determination of TNF-α.
Reconstitution
Please see Certificate of Analysis for details of reconstitution instruction and specific concentration.
Storage
1. Unopened kit should be stored at 2℃-8℃ upon receiving.
2. Find the expiration date on the outside packaging and do not use reagents past their expiration date.
3. The opened kit should be stored per components table. The shelf life is 30 days from the date of opening.
Materials Provided
IDComponentsSizeRES027-C01Pre-coated Anti-TNF-α Antibody Microplate1 plate (8×12 strips)RES027-C02Human TNF-α Standard15 μgRES027-C03Biotin-Anti-TNF-α Antibody20 μgRES027-C04Streptavidin-HRP50 μLRES027-C0510xWashing Buffer50 mLRES027-C062xDilution Buffer50 mLRES027-C07Substrate Solution12 mLRES027-C08Stop Solution7 mLACRO Quality Management System
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Typical Data
Please refer to DS document for the assay protocol.
For each experiment, a standard curve needs to be set for each micro-plate, and the specific OD value may vary depending on different laboratories, testers, or equipments. The following example data is for reference only.
Dilution Linearity
To assess the linearity of the assay, samples spiked with high concentrations of human TNF-α, were serially diluted with calibrator diluent to produce samples with values within the dynamic range of the assay.
Intra-Assay Statistics
Three samples of known concentration were tested twenty times on one plate to assess intra-assay precision, Intra-Assay Precision CV＜10%.
Inter-Assay Statistics
Three samples of known concentration were tested in three separate assays to assess inter-assay precision, Inter-Assay Precision CV<10%.
Recovery
Three parts of blank serum were added with different concentrations of human TNF-α, and the serum without human TNF-α was used as background to calculate the recovery rate. The range of the recovery rate is 89.2-116.0%, and the average recovery is 98.3%.
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Progrès de frontière
Progrès du développement médicamenteux- Nom anglais：
Tumor necrosis factor α
- Catégorie：
- Nombre de médicaments répertoriés：
68 Détails
- Nombre de médicaments cliniques：
74 Détails
- Étape de développement la plus élevée：
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