Catalog No.
KDD68901
Description
PRINCIPLE OF THE ASSAY This assay employs the quantitative competitive enzyme immunoassay technique. Recombinant Human CD40 has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled antibody and then pipetted into the wells. Iscalimab in the sample competitively binds to the pre-coated protein with biotin-labeled Iscalimab. 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 Iscalimab 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 Iscalimab concentration in serum and plasma.
Detection method
Colorimetric
Sample type
Plasma, Serum
Assay type
Quantitative
Range
234.38 - 15,000 ng/mL
Sensitivity
144.20 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) |
8246.9 |
1312.9 |
658.1 |
8109.3 |
2488.5 |
1051.8 |
|
Standard deviation |
1585.8 |
72.7 |
60.5 |
1217.6 |
162.8 |
114.9 |
|
CV (%) |
19.2 |
5.5 |
9.2 |
15.0 |
6.5 |
10.9 |
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
CFZ-533, NVP-CFZ533, OM11-62MF, CAS: 2031153-61-2
Background
Iscalimab is a new, fully human, monoclonal antibody preventing cluster of differentiation 40 (CD40) pathway signaling and activation of CD40+ cell types. In a recent multicenter, randomized control trial (NCT02217410), with the primary endpoint of non-inferiority on the composite endpoint, iscalimab therapy showed non-inferiority on a composite clinical endpoint, improved renal function, reduced risk for new onset diabetes and similar safety compared with tacrolimus. The analysis presented at the ATC included patients from this study that underwent either routine biopsies or biopsies as part of a follow-up protocol. The data was reviewed and scored by a blinded pathologist using the established Banff criteria and CADI. A CADI of 1 or less was considered as 'normal renal histology'. The average CADI at final biopsy was 1.6 ±0.6 for iscalimab and 5.1 ±0.8 for tacrolimus.
For research use only. Not for human or drug use.
