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GenScript Trastuzumab Immunogenicity Kit (Bridging Elisa); 96Tests
List Price
$498.00
Your Price
$498.00
GenScript Trastuzumab Immunogenicity Kit (Bridging Elisa) - GSCRPT (Additional S&H or Hazmat Fees May Apply)
NETA PART:
GSCRPT-L01007
MFG.PART:
L01007
UNSPSC:
41116126
Manufacturer:
GenScript USA Inc
Overview
| Product Description | Trastuzumab, also known as Herceptin, is a human epidermal growth factor receptor 2 (HER2) inhibitor for the treatment of breast cancer. Trastuzumab is a recombinant humanized IgG1 kappa monoclonal antibody. It binds to the extracellular domain of the HER2 protein on the on the surface of HER2-positive tumor cells with high affinity. Trastuzumab can suppress the cells growth and proliferation by blocking the ability of the cancer cells to receive chemical signals. Antibody drugs have the possibility to generate anti-drug antibodies (ADAs), which may alter drug clearance and neutralize target binding, causing reduction of drug efficacy. The immunogenicity of antibody drugs may cause anaphylaxis, infusion reactions, and immune complex disorders. Therefore, it is important to assess the presence and impact of Trastuzumab ADAs on exposure, safety, and efficacy. GenScript Trastuzumab Immunogenicity Kit (Bridging ELISA) is designed for detection of anti-Trastuzumab antibody in serum and plasma samples. This kit utilizes a validated bridging immunoassay method based on the FDA, EMA and NMPA Immunogenicity Guidelines. Through rigorous validation studies, the kit has been demonstrated high sensitivity, specificity, and is free from matrix effects. It is an ideal tool for the analysis of ADA against Trastuzumab. |
Product Introduction
| Sensitivity | 0.78 ng/mL | ||||||||||||||||||||||||||||||
| Detection Range | 0.78-50 ng/mL | ||||||||||||||||||||||||||||||
| Precision | Intra-Assay: Inter-Assay: CV≤15% | ||||||||||||||||||||||||||||||
| Minimum required dilution (MRD) | 1:5, validated non-human primate plasma | ||||||||||||||||||||||||||||||
| Hook Effect | Not observed at 3,200 ng/mL of anti-Trastuzumab antibodies | ||||||||||||||||||||||||||||||
| Conveniency | All reagents and buffers for the test are provided and the test can be completed within 2 hours | ||||||||||||||||||||||||||||||
| Kit Contents |
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| Storage | The unopened kit is stable for at least 12 months from the date of manufacture at 2°C to 8°C, and the opened kit is stable for up to 1 month from the date of opening at 2°C to 8°C. |
Assay Principle
| Assay Principle | The GenScript Trastuzumab Immunogenicity ELISA Kit is a bridging immunoassay that utilizes a microplate coated with the Trastuzumab. When standards or samples are added to the capture plate, anti-Trastuzumab antibodies can be captured on the plate. The biotin-conjugated Trastuzumab is then added to interact with the anti-Trastuzumab antibodies bound on the plate. After a washing step, horseradish peroxidase conjugated streptavidin (Streptavidin-HRP) is added and to react with the 3,3,5,5-Tetramethylbenzidine solution (TMB Solution) to develop a blue product in the solution. The reaction is stopped by adding stop solution, which turns the color yellow and the absorbance can be read at 450 nm by a microplate reader. The intensity of the reaction color is directly proportional to the concentration of antibodies to Trastuzumab in samples. |
| Reference | 1. Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody Detection. 2. Immunogenicity of Trastuzumab in patients with advanced tumors. 3. Technical Guideline on Immunogenicity of Therapeutic Agents, NMPA, 2021.03. 4. Immunogenicity Testing of Therapeutic Protein Products- Developing and Validating Assays for Anti-Drug Antibody Detection Guidance for Industry, January 2019. 5. Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins (EMEA/CHMP/BMWP/14327/2006 Rev 1), 1st Dec 2017. |
For research use only. Not intended for human and animal therapeutic or diagnostic use.
| SKU | GSCRPT-L01007 |
|---|---|
| Featured | No |
| Supplier Part Number | L01007 |
| UM | EA |
| UNSPSC | 41116126 |
| Manufacturer | GenScript USA Inc |
| Temperature | The unopened kit is stable for at least 12 months from the date of manufacture at 2°C to 8°C, and the opened kit is stable for up to 1 month from the date of opening at 2°C to 8°C. |
| ProductLine | GSCRPT |
| Qty | 1 |
| MinOrderQty | 1 |
| Weight | 7.000000 |
| Lead Time | 7 |
| Hazardous | Y |
| Energy Star | No |
| Green | No |
| ACT Ecolabel | No |
| Controlled | N |