E. coli HCP ELISA Kit (Applicable Strains: BL21(DE3), W3110, TG1)

Name: E. coli HCP ELISA Kit (Applicable Strains: BL21(DE3), W3110, TG1)
SKU: DEIABY267
Rating: 5 (1 reviews)

Regulatory status: For research use only, not for use in diagnostic procedures.

COA

SDS

Datasheet

Summary

Sample

Biological products

Detection Method

Sandwich-ELISA

Intended Use

This kit is designed for the quantitative analysis of host cell protein (HCP) residuals in protein-based drugs produced using E. coli cells as the expression system.

Contents of Kit

No.	Components	Size	Storage Conditions
1	Pre-coated Microplate	96T × 1 plate (strips)	2-8°C (Sealed)
2	Standard Stock Solution (500 μg/mL)	50 μL × 1 vial	2-8°C
3	Detection Antibody (100×)	150 μL × 1 vial	2-8°C
4	TMB Substrate	10 mL × 1 bottle	2-8°C (Protect from light)
5	Stop Solution	10 mL × 1 bottle	2-8°C
6	Wash Buffer (20×)	10 mL × 5 bottles	2-8°C
7	Diluent (10×)	10 mL × 1 bottle	2-8°C
8	Plate Sealer	4 sheets

Storage

Store kit at 2 - 8°C. Do not use kit after expiration date.

Performance Characteristics

Advantages
• Broad Coverage: The antibodies possess strong HCP recognition capability, achieving >80% coverage with stable performance.
• High Titer: The antibodies used in this kit demonstrate a titer of up to 10⁶ when tested by indirect ELISA.
• High Sensitivity: Serum antibodies are purified using affinity chromatography to minimize non-specific antibodies.
• High Stability: The production process incorporates broad-spectrum protein stabilizers and specialized microplate treatment to enhance the thermal stability of standards and plates, ensuring result reproducibility.
• Robust Applicability: The kit has been tested under varying reaction temperatures (20-30°C) and incubation times (±10 minutes), showing good reproducibility.
• Optimized Diluent: The use of an optimized sample diluent reduces non-specific adsorption during sample testing, resulting in very low background color, which facilitates accurate concentration determination.

Precision

Intra-assay CV%: 7.3 - 13.1%
Inter-assay CV%: 8.1 - 11.5%

Sensitivity

LOD: 0.195 ng/mL
LOQ: 0.39 ng/mL

General Description

E. coli is a widely used expression system for recombinant proteins. During the extraction process, a large number of host proteins are released alongside the target protein. These host cell proteins (HCPs) are highly immunogenic and can trigger adverse toxic or immune reactions, compromising product safety and quality.
Reducing HCP residues to the lowest possible level is essential in downstream biopharmaceutical processing. Regulatory agencies recognize the Enzyme-Linked Immunosorbent Assay (ELISA) as the "gold standard" for HCP detection due to its exceptional sensitivity.

Standard Curve