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产品参数（Product Specifications）
Assay TypeIndirect-ELISAAnalyteAnti-CD3 AntibodyFormat96T(8×12 strips)Reactivity/Regulatory StatusRUOSensitivity≤0.125ng/mLStandard Curve Range0.125 ng/mL-4 ng/mLAssay Time2 hr 20 minSuitable Sample TypeFor the quantitative determination of anti-CD3 antibody in Bioprocess manufacturing applications.Sample volume100 uL产品概述（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.
重构方法（Reconstitution）
Please see Certificate of Analysis for details of reconstitution instruction and specific concentration.
存储（Storage）
2-8℃
组分（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 mL原理（Assay Principles）
This assay kit employs a standard indirect-ELISA format, providing a rapid detection of Anti-CD3 antibodies. The kit consists of Pre-coated Human CD3E & CD3G Microplate and Anti-CD3 Antibody Standard and HRP-conjugated antibody and related buffer.
Your experiment will include 5 simple steps:
a) Bring all reagents to room temperature(20℃-25℃) before use.
b) Add your sample to the plate and take the Anti-CD3 Antibody as standard. The samples and standard are diluted by Dilution Buffer.
c) Wash the plate and add the HRP-conjugated antibody diluted by Dilution Buffer to the plate.
d) Wash the plate and add TMB.
e) Stop the substrate reaction by adding diluted acid. Absorbance (OD) is calculated as the absorbance at 450 nm minus the absorbance at 630 nm to remove background disturbance before statistical analysis. The OD Value reflects the amount of Antibody bound.
质量管理控制体系（QMS）
产品展示
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 micro-plate, and the specific OD value may vary depending on different laboratories, testers, or equipments. The following example data is for reference only.
稀释线性（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.
批内差异（Intra-Assay Statistics）
Three samples of known concentration were tested ten times on one plate to assess intra-assay precision.
批间差异（Inter-Assay Statistics）
Three samples of known concentration were tested in three separate assays to assess inter-assay precision.
回收率（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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