resDetect™ Universal Protein A Quick ELISA Kit (Boiling-free)

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RES-A029-96tests
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RES-A029
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FAB
  • High Recovery - Optimized dissociation process to ensure thorough dissociation between drug and Protein A leached, to get satisfactory recovery even for samples of low recovery.
  • Universality - Suitable for detection of natural or structurally conserved recombinant forms of Protein A and alkaline-resistant Protein A variants, such as MabSelect SuRe™ , MaXtar® ARPA ligand (Bio-Link Co.), UniMab® 50 Protein A (NanoMicro) 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.
  • Efficient sample processing methods - adding denaturing reagents to prepare samples that the sample processing is just about 15 mins.
  • High sensitivity - Sensitivity < 40 pg/mL of recombinant forms of Protein A and alkaline-resistant Protein A variants.
  • High IgG tolerance - Accurately quantify protein A in up to 20 mg/mL antibody.
  • Excellent buffer compatibility - Compatible with various buffer systems.
  • Extensive validation - Comprehensive verification of specificity, sensitivity, precision, accuracy, applicability, and other aspects.
Product Specifications

Assay Type
Sandwich-ELISA
Analyte
Protein A
Format
96T (8×12 strips)
Regulatory Status
RUO
Sensitivity
<40 pg/mL
Standard Curve Range
50 pg/mL-1600 pg/mL(Protein A)
50 pg/mL-3200 pg/mL(PrismA)
Assay Time
2 h
Suitable Sample Type
For the quantitative determination of recombinant Protein A, alkaline-resistant Protein A, PrismA and MaXtar® ARPA ligand Protein A.
Sample volume
25 μL

Product Overview

Protein A is a cell wall protein of Staphylococcus aureus. Due to its high affinity with the Fc part of certain immunoglobulins (especially IgG), it is widely used in the purification of antibody drugs. However, during the purification , protein A may leach from the purification column and resulte in contamination of the antibody drugs prepared. Protein A has a variety of specific biological characteristics, so there are strict regulations on the acceptable level of Protein A in antibody drug preparations. Therefore, the detection of residual Protein A in antibody drugs purified from Protein A purification column is a key quality control step in the production process of antibody drug preparations.

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

ID
Components
Size
RES029-C01
Pre-Coated Anti-Protein A Antibody Microplate
1 plate (8×12 strips)
RES029-C02A
Alkali-Tolerant Recombinant Protein A Standard (1 μg/mL)
100 μL
RES029-C02B
MaXtar® ARPA ligand Protein A Standard (Bio-Link Co.) (1 μg/mL)
100 μL
RES029-C02C
Recombinant PrismA Standard (1 μg/mL)
100 μL
RES029-C03
Recombinant Protein A Standard (1 μg/mL)
100 μL
RES029-C04
Biotin-Anti-Protein A Antibody
1.5 mL
RES029-C05
Streptavidin-HRP
10 μg
RES029-C06
10×Sample Dilution Buffer
15 mL
RES029-C07
Denaturation Buffer
15 mL
RES029-C08
20×Washing Buffer
30 mL
RES029-C09
Antibody Dilution Buffer
15 mL
RES029-C10
Streptavidin-HRP Dilution Buffer
15 mL
RES029-C11
Substrate Solution
12 mL
RES029-C12
Stop Solution
8 mL