Catalog No.
KAH02251
Description
PRINCIPLE OF THE ASSAY
This assay employs the quantitative competitive enzyme immunoassay technique. Pembrolizumab has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled Human CD279 antigen and then pipetted into the wells. Anti-Pembrolizumab Neutralizing Antibody in the sample competitively binds to Pembrolizumab with the biotin-labeled Human CD279 antigen. 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 Anti-Pembrolizumab Neutralizing Antibody 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 Anti-Pembrolizumab Neutralizing Antibody concentration in serum and plasma.
Detection method
Colorimetric
Sample type
Plasma, Serum
Assay type
Quantitative
Range
7.81 - 500 ng/mL
Sensitivity
6.90 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)
|
292.6
|
78.7
|
19.0
|
293.1
|
75.5
|
21.7
|
|
Standard deviation
|
15.7
|
7.4
|
3.7
|
27.1
|
4.2
|
3.3
|
|
CV (%)
|
5.4
|
9.3
|
19.5
|
9.2
|
5.6
|
15.1
|
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
MK-3475, CAS: 1374853-91-4
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For research use only. Not for human or drug use.
