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GenScript Pertuzumab Immunogenicity Kit (Bridging Elisa); 96 tests
List Price
$498.00
Your Price
$498.00
GenScript Pertuzumab Immunogenicity Kit (Bridging Elisa) - GSCRPT (Additional S&H or Hazmat Fees May Apply)
NETA PART:
GSCRPT-L00979
MFG.PART:
L00979
UNSPSC:
41116126
Manufacturer:
GenScript USA Inc
Overview
| Product Description | Pertuzumab, marketed under the brand name Perjeta, is a HER2/neu receptor antagonist. It is used in combination with trastuzumab for the treatment of patients with HER2-positive tumors. It is a humanized IgG1 monoclonal antibody produced in mammalian cells. |
Product Introduction
| Sensitivity | 2.5 ng/mL | ||||||||||||||||||||||||||||||
| Detection Range | 1.25-80 ng/mL | ||||||||||||||||||||||||||||||
| Precision | Intra-Assay: Inter-Assay: CV≤15% | ||||||||||||||||||||||||||||||
| Minimum required dilution (MRD) | 1:10, validated non-human primate plasma | ||||||||||||||||||||||||||||||
| Hook Effect | Not observed at 9,720 ng/mL of anti-Pertuzumab 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 Pertuzumab Immunogenicity ELISA Kit is a bridging immunoassay that utilizes a microplate coated with the Pertuzumab. During the first incubation period, both anti-Pertuzumab antibodies and biotin-conjugated Pertuzumab are added to each well of the plate and then incubated simultaneously. 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 Pertuzumab in samples. |
| Reference | 1. Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody Detection. 2. Immunogenicity of Pertuzumab 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-L00979 |
|---|---|
| Supplier Part Number | L00979 |
| 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 |
| Controlled | N |