Catalog No.
KDD15101
Description
PRINCIPLE OF THE ASSAY
This assay employs the quantitative competitive enzyme immunoassay technique. Recombinant Human CD62P has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled antibody and then pipetted into the wells. Crizanlizumab in the sample competitively binds to the pre-coated protein with biotin-labeled Crizanlizumab. 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 Crizanlizumab 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 Crizanlizumab concentration in serum and plasma.
Detection method
Colorimetric
Sample type
Plasma, Serum
Assay type
Quantitative
Range
31.25 - 2,000 ng/mL
Sensitivity
3.94 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)
|
933.2
|
190.7
|
35.3
|
1383.7
|
209.0
|
47.5
|
Standard deviation
|
125.2
|
34.0
|
6.9
|
274.6
|
25.5
|
9.4
|
CV (%)
|
13.4
|
17.8
|
19.6
|
19.8
|
12.2
|
19.7
|
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
SelG1, CAS: 1690318-25-2
Background
Crizanlizumab is a humanized monoclonal antibody directed against P-selectin that showed effectiveness in preventing VOC induced pain crises. Median rate of pain crises was 1.63 in crizanlizumab treated group versus 2.998 in placebo group. Furthermore, the median time to crisis was 4.07 months with crizanlizumab compared to 1.38 in the placebo group. The benefits of treatment held true within subgroups including those with a high number of VOC prior to treatment and those with more severe genotype. The drug is FDA approved to reduce the frequency of VOC in adults and pediatric patients with SCD aged 16 years and older.
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