Catalog No.
KDB86903
Description
PRINCIPLE OF THE ASSAY This assay employs the quantitative competitive enzyme immunoassay technique. Recombinant Human EGFR has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled antibody and then pipetted into the wells. Necitumumab in the sample competitively binds to the pre-coated protein with biotin-labeled Necitumumab. After washing away any unbound substances, Streptavidin-HRP is added to the wells. Following a wash to remove any unbound enzyme reagent, a substrate solution is added to the wells and color develops in inversely proportion to the amount of Necitumumab bound in the initial step. The color development is stopped and the intensity of the color is measured.
Applications
Used for the quantitative determination of Necitumumab concentration in serum and plasma.
Detection method
Colorimetric
Sample type
Plasma, Serum
Assay type
Quantitative
Range
9.38 - 600 ng/mL
Sensitivity
6.05 ng/mL
Precision
Intra-Assay Precision (Precision within an assay): <20%
Three samples of known concentration were tested sixteen times on one plate to assess intra-assay precision.
Inter-Assay Precision (Precision between assays): <20%
Three samples of known concentration were tested in twenty four separate assays to assess inter-assay precision.
|
|
Intra-Assay Precision |
Inter-Assay Precision |
||||
|
Sample |
1 |
2 |
3 |
1 |
2 |
3 |
|
n |
16 |
16 |
16 |
24 |
24 |
24 |
|
Mean (ng/mL) |
392.4 |
71.0 |
24.2 |
231.4 |
65.8 |
23.4 |
|
Standard deviation |
61.0 |
9.5 |
3.6 |
44.5 |
11.9 |
4.5 |
|
CV (%) |
15.5 |
13.4 |
15.1 |
19.2 |
18.1 |
19.2 |
Recovery
80-120%
Shipping
2-8 ℃
Stability and Storage
When the kit was stored at the recommended temperature for 6 months, the signal intensity decreased by less than 20%.
Alternative Names
11F8, IMC-11F8, LY3012211, CAS: 906805-06-9
Background
Necitumumab (IMC-11F8, LY3012211) is a second-generation fully human immunoglobulin (Ig) G1 kappa isotype monoclonal antibody (mAb) that acts as an antagonist to direct against the extracellular region of epidermal growth factor receptor (EGFR). It was developed by Eli Lilly & Co (Indianapolis, IN, USA) and produced in genetically engineered mammalian NS0 cells. It was first approved by the U.S. Food and Drug Administration (FDA) under the brand name Portrazza in 2015, for use in combination with cisplatin and gemcitabine as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC). After that, it has gained the approval for marketing in the Europe Union and Japan respectively in 2016 and 2017. It is not indicated for treatment of non-squamous NSCLC. Currently, there are several ongoing clinical trials investigating necitumumab in the treatment of NSCLC in several di铿€erent settings. It is currently being studied in combination with pre-existing agents, such as osimertinib, pembrolizumab, nabpaclitaxel, and carboplatin, as well as with new agents under investigation, abemaciclib and AZD9291. Necitumumab is currently being evaluated in the second-line setting following treatment failure or progression with front-line EGFR tyrosine kinase inhibitors (TKIs) and platinum-based chemotherapy.
For research use only. Not for human or drug use.
