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GenScript Pembrolizumab Immunogenicity Kit (Bridging Elisa); 96Tests
List Price
$498.00
Your Price
$498.00
GenScript Pembrolizumab Immunogenicity Kit (Bridging Elisa) - GSCRPT (Additional S&H or Hazmat Fees May Apply)
NETA PART:
GSCRPT-L00971
MFG.PART:
L00971
UNSPSC:
41116126
Manufacturer:
GenScript USA Inc


Overview
Product Description | Pembrolizumab, with the brand name Keytruda, is a humanized monoclonal antibody of IgG4 isotype. It targets the programmed cell death protein 1 (PD-1) receptor of lymphocytes, allowing the immune system to destroy cancer cells. Pembrolizumab is an immunotherapy drug. It is used for the treatment of patients with lung cancer, head and neck cancer, and stomach cancer. |
Product Introduction
Sensitivity | 1.56 ng/ml | |||||||||||||||||||||||||||||||||
Detection Range | 1.56-50 ng/mL | |||||||||||||||||||||||||||||||||
Precision | Intra-assay≤10% Inter-assay≤15% | |||||||||||||||||||||||||||||||||
Minimum required dilution (MRD) | 1:5, validated non-human primate plasma | |||||||||||||||||||||||||||||||||
Conveniency | All reagents and buffers for the test are provided and the test can be completed within 2.5 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 | GenScript Pembrolizumab Immunogenicity ELISA Kit is a bridging immunoassay that contains a microplate coated with the pembrolizumab. During the first incubation period, anti-Pembrolizumab antibody and biotin conjugated Pembrolizumab are added to each well of the plate and then incubated at the same time. After a washing step, horseradish peroxidase conjugated streptavidin is added and to react with the TMB substrate 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 pembrolizumab in samples. |
Reference | 1, ImmunogenicityTesting of Therapeutic Protein Products — Developing and Validating Assays forAnti-Drug Antibody Detection. 2, Immunogenicity of pembrolizumab in patients withadvanced tumors. 3, Technical Guideline on Immunogenicityof Therapeutic Agents,NMPA, 2021.03. 4, Immunogenicity Testing of Therapeutic ProteinProducts- Developing and Validating Assays for Anti-Drug Antibody DetectionGuidance for Industry, January 2019. 5, |
For research use only. Not intended for human and animal therapeutic or diagnostic use.
SKU | GSCRPT-L00971 |
---|---|
Supplier Part Number | L00971 |
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 |