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Product Specifications
Assay TypeSandwich-ELISAAnalyteVH3 binding Protein AFormat96T (8×12 strips)Regulatory StatusRUOSensitivity＜50 pg/mLStandard Curve Range50 pg/mL-8100 pg/mLAssay Time2 hrSuitable Sample TypeFor the quantitative determination of recombinant VH3 binding protein ASample volume50 μLProduct Overview
VH3 ELISA Kit (Residue Testing) is based on Sandwich-ELISA and is used to measure both natural and recombinant forms of VH3 residues in antibody drug preparations, including structurally distinct variants such as MabSelect™ VH3. It is designed to provide an essential tool for optimal purification process development and routine quality control of in-process streams and final products, ensuring the accurate monitoring of VH3 levels and maintaining product quality.
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
IDComponentsSizeRES059-C01Pre-Coated Anti-VH3 Antibody Microplate1 plate (8×12 strips)RES059-C02Recombinant VH3 binding Protein A Standard (1 μg/mL)100 μLRES059-C03Biotin-Anti-VH3 Antibody1.5 mLRES059-C04Streptavidin-HRP10μgRES059-C0510×Sample Dilution Buffer15 mLRES059-C06Denaturation Buffer15 mLRES059-C0720×Washing Buffer30 mLRES059-C08Antibody Dilution Buffer15 mLRES059-C09Streptavidin-HRP Dilution Buffer15 mLRES059-C10Substrate Solution12 mLRES059-C11Stop Solution8 mLACRO Quality Management System
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Affichage des données
Typical Data
Please refer to DS document for the assay protocol.
Detection of Recombinant VH3 binding Protein A by sandwich-ELISA Assay.
Immobilized Anti-VH3 binding Protein A Antibody can bind Recombinant VH3 binding Protein A. Detection was performed using Biotin-Anti-VH3 Antibody with sensitivity of 50 pg/mL (QC tested). 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.
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
Add different concentrations of VH3 binding Protein A (0.2ng/mL、1ng/mL、10ng/mL) to different concentrations of Human IgG4 (Toripalimab) (20mg/mL、10mg/mL、5mg/mL), then dilute the antibodies to a reasonable range, then test and calculated the concentration of VH3 binding protein A to give the recovery rate.
Interference effect
We have conducted interference effect test about frequently-used buffers, they have excellent buffer compatibility. For specific buffers, it is recommended that you verify recovery to determine the minimum dilution ratio.
Specificity
Host cell protein (HCP 500 ng/mL) and host cell DNA (HCD 0.5 ng/mL) of HEK293, E.coli or CHO systems were added to human IgG1 (Bevacizumab, 1mg/mL) and human IgG4 (Toripalimab, 1mg/mL), respectively, which were higher than the usual quality standard limit. Then high, medium, and low concentrations of VH3 binding Protein A were added, respectively, and the ratio of VH3 binding Protein A recovery in the VH3 binding Protein A added samples without HCP and HCD was added as the specificity verification index.
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