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Protein A-based affinity chromatography is one of the most commonly applied purification technologies for monoclonal antibody therapeutics. During purification, leached Protein A may enter the final drug substance and cause product contamination.
This kit is designed for the quantitative detection of residual Protein A impurities in biopharmaceutical products. It is capable of identifying both native Protein A and recombinant Protein A ligands, including MabSelect SuRe™.
Compared with traditional methods, this kit detects Protein A without sample pretreatment, featuring simple operation and a short assay time.
For research and in-process quality control use only. Not for diagnostic use in humans or animals.
Product images are for reference only.
Applications
This product adopts a sandwich ELISA format to quantify Protein A in test samples.
Advantages
(1) High universality | Compatible with various Protein A ligands
Supports mainstream resin ligands including: MabSelect SuRe™ (Cytiva), MaXtar ARPA ligand (Biolink), MabCap At 4FF / AbCap 4FF / MabCap At LX (Smart-Lifesciences), MabPurix A65 (Sepax Technologies), etc.
(2) Rapid & Time-Saving | No sample boiling required, time‑ and labor‑saving
Removes cumbersome pre-treatment steps such as high-temperature incubation and centrifugation, allowing direct sample loading and minimizing operational errors. Optimized dilution protocol with high anti-interference capacity against IgG (tolerates IgG up to 5 mg/mL).
(3) Sensitive and accurate | Ultra‑low limit of detection with reliable and stable data
Limit of detection (LOD): 5.2 pg/mL, enabling accurate detection of trace residues.
Linear range: 5.2–1600 pg/mL, covering a wide concentration range of samples.
Spike recovery: 85.0%–115.0%, showing excellent recovery for different resin ligands.
Information
(1) Product Name：Protein A Detection ELISA Kit PLUS
(2) Catalog No. : K061-2
(3) Size : 48T / 96T
(4) Sensitivity
- Recombinant protein A:
Limit of Detection (LOD): 5.2 pg/mL
Limit of Quantitation (LOQ): 10.1 pg/mL
- MabSelect SuReTM protein A:
Limit of Detection (LOD): 5.4 pg/mL
Limit of Quantitation (LOQ): 9.8 pg/mL
(5) Linear range
The linear range is from 5.2 to 1600 pg/mL.
(6) Recovery rate
The spike recovery ranges from 85.0% to 115.0%.
(7) Inter-batch coefficient of variation
The inter-batch coefficient of variation (CV) is ≤ 10.0%.
(8) Specificity
This kit detects native and recombinant Protein A, including MabSelect SuRe™.