Catalog No.
KDC82802
Description
PRINCIPLE OF THE ASSAY This assay employs the quantitative indirect enzyme immunoassay technique. Human TFPI has been pre-coated onto a microplate. Standards or samples are pipetted into the wells and any Concizumab present is bound by the immobilized protein. After washing away any unbound substances, a biotin-labeled Mouse Anti-Human IgG antibody is added to the wells. 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 proportion to the amount of Concizumab 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 Concizumab concentration in serum and plasma.
Detection method
Colorimetric
Sample type
Plasma, Serum
Assay type
Quantitative
Range
6.25 - 200 ng/mL
Sensitivity
3.58 ng/mL
Precision
Intra-Assay Precision (Precision within an assay): <10%
Three samples of known concentration were tested sixteen times on one plate to assess intra-assay precision.
Inter-Assay Precision (Precision between assays): <15%
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) | 80.4 | 24.8 | 11.8 | 76.1 | 24.3 | 12.2 |
Standard deviation | 4.2 | 0.9 | 0.8 | 3.8 | 1.1 | 0.9 |
CV (%) | 5.3 | 3.7 | 6.6 | 4.9 | 4.4 | 7.6 |
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
Anti-TFPI, NN7415, mab2021, CAS: 1312299-39-0
Background
Concizumab (mAb 2021) is a high-affinity, humanized, monoclonal IgG4 antibody (mAb) developed by Novo Nordisk A/S. It was directed against the Kunitz-2 domain of human tissue factor (TF) pathway inhibitor (TFPI), designed to target and selectively block the factor X (FX) a (FXa) binding site of TFPI. As a mAb, concizumab has the advantage of being administered subcutaneously, and exhibits good solubility and stability, allowing administration as a liquid formulation via a ready- and easy-to-use portable pen device. Phase 2 trials of concizumab are ongoing for Haemophilia A and B. On 12 October 2017, orphan designation (EU/3/17/1940) was granted by the European Commission to Novo Nordisk A/S, Denmark, for concizumab for the treatment of haemophilia B.
