Catalog No.
KDD17202
Description
PRINCIPLE OF THE ASSAY This assay employs the quantitative competitive enzyme immunoassay technique. Recombinant Human CD152 has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled antibody and then pipetted into the wells. Tremelimumab in the sample competitively binds to the pre-coated protein with biotin-labeled Tremelimumab. 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 Tremelimumab 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 Tremelimumab concentration in serum and plasma.
Detection method
Colorimetric
Sample type
Plasma, Serum
Assay type
Quantitative
Range
234.38 - 15,000 ng/mL
Sensitivity
48.85 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) |
9104.9 |
2196.7 |
423.8 |
9765.7 |
2311.2 |
454.9 |
Standard deviation |
785.0 |
259.7 |
79.9 |
726.8 |
260.2 |
90.0 |
CV (%) |
8.6 |
11.8 |
18.8 |
7.4 |
11.3 |
19.8 |
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
Ticilimumab, CP-675, CP-675, 206, CP-675206 clone 11.2.1, CAS: 745013-59-6
Background
Tremelimumab (CP-675,206; previously, ticilimumab) is a fully human IgG2 monoclonal antibody and has a half-life of 22 days, which was generated in a XenoMouse murine system, that has a subnanomolar affinity for binding to human cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) for treatment of patients with advanced cancers. Treatment with an anti-CTLA4 mAb prevents normal downregulation of T cells and prolongs T cell activation, thereby enhancing immune function. Generated at Abgenix (Fremont, CA) using xenomice by Pfizer, Inc. (New York), tremelimumab has been undergoing human trials for the treatment of malignant melanoma. Additionally, tremelimumab is under investigation for the treatment of Mesothelioma, Liver Cancer, Liver Neoplasms, Liver Cell Caricinoma, and HepatoCellular Carcinoma and it has been investigated in Part C: Malignant Mesothelioma and Part A and B: Advanced Solid Malignancies. Recently, it has been announced by AstraZeneca and MedImmune that tremelimumab as monotherapy does not improve survival and the primary end point is not reached (D4880C00003; NCT01843374). Further data regarding DETERMINE was presented at ASCO 2016, detailing that 571 patients were enrolled and that 81% had died throughout the duration of the study. There was no statistically significant difference between treated patients and placebo patients, and side effects such as diarrhoea, loss of appetite and development of rashes were seen at higher rates in treated patients than in placebo treatments. This indicates a need for further research into the use of tremelimumab as a monotherapy as well as use in combination therapy to potentially achieve better clinical outcomes.