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Product Details
Product Specifications
Assay TypeIndirect-ELISAFormat96T (8×12 strips)AnalyteAnti-CD3 AntibodyReactivity/Regulatory StatusRUOAssay Time2 hr 20 minSample volume100 μLSensitivity≤0.125 ng/mLStandard Curve Range0.125 ng/mL-4 ng/mLSuitable Sample TypeFor the quantitative determination of anti-CD3 antibody in Bioprocess manufacturing applications.Product Overview
resDetect™ Anti-CD3 Antibody Indirect ELISA Kit (Residue Testing) is based on the Indirect-ELISA method and is used to detect and quantitatively determine anti-CD3 antibody residues in cell therapy products. It is designed to provide a reliable solution for cell therapy product quality assessment during drug development and CMC quality control stages.
Reconstitution
Please see Certificate of Analysis for details of reconstitution instruction and specific concentration.
Storage
1.Store the unopened kit at 2-8°C upon receipt.
2.Locate the expiration date on the outer packaging and do not use reagents beyond their expiration date.
Materials Provided
IDComponentsSizeRES095-C01Pre-coated Human CD3E & CD3G Microplate1 plate (8×12 strips)RES095-C02Anti-CD3 Antibody Standard20 μgRES095-C03HRP-conjugated antibody10 μgRES095-C0410×Washing Buffer50 mLRES095-C052×Dilution Buffer50 mLRES095-C06Substrate Solution12 mLRES095-C07Stop Solution7 mLACRO Quality Management System
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Performance Data
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 Anti-CD3 Antibody 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 ten times on one plate to assess intra-assay precision.
Inter-Assay Statistics
Three samples of known concentration were tested in three separate assays to assess inter-assay precision.
Recovery
Five parts of blank T cell culture supernatant were added with different concentrations of Anti-CD3 Antibody, and the T cell culture supernatant without Anti-CD3 Antibody was used as background to calculate the recovery rate. The range of the recovery rate is 81.3-102.5%, and the average recovery is 89.0%.
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Drug Development Progress- English Name：
T cell surface glycoprotein CD3
- Category：
- Approved Drugs：
10 Details
- Drugs in Clinical Trials：
198 Details
- Highest Development Stage：
Approved
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