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Product Details
FAB
- Universality - Suitable for detection of natural or structurally conserved recombinant forms of Protein A and alkaline-resistant Protein A variants, such as MabSelect SuRe™ and other ligands
- Fast time to results - less than 2 hours
- Accuracy - Tracebility of Protein A standards against BSA Standard with validated pharmacopoeia quantitation methodology
- Extensive validation - Validation Report (ICH compliant) available on request
- High sensitivity - Sensitivity < 20 pg/mL of recombinant Protein A and MabSelect™ SuRe Protein A or other Protein A ligands
- High IgG tolerance - Accurately quantify protein A in up to 10 mg/mL antibody
- Excellent buffer compatibility
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Product Specifications
Assay TypeSandwich-ELISAAnalyteProtein AFormat96T (8×12 strips)Regulatory StatusRUOSensitivity< 20 pg/mLStandard Curve Range25 pg/mL-1600 pg/mLAssay Time2 hrSuitable Sample TypeFor the quantitative determination of recombinant Protein A, alkaline-resistant Protein A and MaXtar® ARPA ligand Protein A.Sample volume50 μLProduct Overview
Universal Protein A Quick ELISA kit is based on the ELISA sandwich method and is used to detect both natural and structurally conserved recombinant forms of Protein A, as well as recombinant variants with significant structural differences, such as MabSelect SuRe™, MaXtar® ARPA ligand (Bio-Link Co.), and others. It is designed to provides an essential tool for optimal purification process development and routine quality control of in-process streams and final products, ensuring accurate monitoring of Protein A levels and maintaining product quality.
Storage
Unopened kit should be stored at 2°C-8°C upon receiving.
Find the expiration date on the outside packaging and do not use reagents past their expiration date.
The opened kit should be stored per components table. The shelf life is 30 days from the date of opening.
Materials Provided
IDComponentsSizeRES024-C01Pre-Coated Anti-Protein A Antibody Microplate1 plate (8×12 strips)RES024-C02AAlkali-Tolerant Recombinant Protein A Standard (1 μg/mL)100 μLRES024-C02BMaXtar® ARPA ligand Protein A Standard (Bio-Link Co.) (1 μg/mL)100 μLRES024-C03Recombinant Protein A Standard (1 μg/mL)100 μLRES024-C04Biotin-Anti-Protein A Antibody700 μLRES024-C05Streptavidin-HRP300 μLRES024-C06Dilution Buffer100 mLRES024-C0720×Washing Buffer30 mLRES024-C08Substrate Solution12 mLRES024-C09Stop Solution6 mLACRO Quality Management System
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Performance Data
Typical Data
Please refer to DS document for the assay protocol.
Detection of Recombinant Protein A by sandwich-ELISA Assay.
Immobilized Anti-Protein A Antibody can bind Recombinant Protein A. Detection was performed using Biotin-Anti-Protein A Antibody with sensitivity of 25 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.
Detection of Alkali-Tolerant Recombinant Protein A by sandwich-ELISA Assay.
Immobilized Anti-Protein A Antibody can bind Alkali-Tolerant Recombinant Protein A. Detection was performed using Biotin-Anti-Protein A Antibody with sensitivity of 25 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.
Detection of MaXtar® ARPA ligand Protein A (Bio-Link Co.) by sandwich-ELISA Assay.
Immobilized Anti-Protein A Antibody can bind MaXtar® ARPA ligand Protein A (Bio-Link Co.). Detection was performed using Biotin-Anti-Protein A Antibody with sensitivity of 25 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, Intra-Assay Precision CV＜10%.
Inter-Assay Statistics
Three samples of known concentration were tested in ten separate assays to assess inter-assay precision, Inter-Assay Precision CV<20%.
Recovery
The following recovery tests were conducted by adding different concentrations of Protein A to Human IgG1（Bevacizumab）, and the final concentration of Human IgG1（Bevacizumab）is 10mg/mL to calculate the recovery rate. For Recombinant Protein A, Alkali-Tolerant Recombinant Protein A and MaXtar® ARPA ligand Protein A (Bio-Link Co.), the recovery ranges are 98-118%, 86-109% and 79-106%, respectively.
The following recovery tests were conducted by adding different concentrations of Protein A to Human IgG4（Toripalimab）, and the final concentration of Human IgG4（Toripalimab）is 10mg/mL to calculate the recovery rate. For Recombinant Protein A, Alkali-Tolerant Recombinant Protein A and MaXtar® ARPA ligand Protein A (Bio-Link Co.), the recovery ranges are 97-106%, 93-104% and 86-105%, respectively.
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) and host cell DNA (HCD) were added to human IgG1 (Bevacizumab) and human IgG4 (Toripalimab), respectively, which were higher than the usual quality standard limit. Then three samples of known concentration of Protein A were added, respectively, and the ratio of Protein A recovery in the Protein A added samples without HCP and HCD was added as the specificity verification index. The calculation formula was as follows: (S3-S1) / (S2-S1) × 100%, the experimental design is as follows.
The specificity results are as follows.
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