Catalog No.
KDG52001
Description
PRINCIPLE OF THE ASSAY This assay employs the quantitative competitive enzyme immunoassay technique. Recombinant Human MSLN has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled antibody and then pipetted into the wells. Amatuximab in the sample competitively binds to the pre-coated protein with biotin-labeled Amatuximab. 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 Amatuximab 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 Amatuximab concentration in serum and plasma.
Detection method
Colorimetric
Sample type
Plasma, Serum
Assay type
Quantitative
Range
125 - 8,000 ng/mL
Sensitivity
78.43 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) |
4417.2 |
1223.4 |
257.1 |
4619.2 |
1151.9 |
250.2 |
Standard deviation |
189.4 |
154.2 |
8.9 |
413.3 |
88.0 |
33.2 |
CV (%) |
4.3 |
12.6 |
3.5 |
8.9 |
7.6 |
13.3 |
Recovery
80-120%
Shipping
2-8 ℃
Stability and Storage
The stability of ELISA kit is determined by the loss rate of activity. The loss rate of this kit is less than 10% prior to the expiration date under appropriate storage condition.
Alternative Names
MORAb-009, CAS: 931402-35-6
Background
Amatuximab, alternative names: MORAb-009, anti-MSLN monoclonal antibody (MAb) is a chimeric, humanized IgG1/k MAb that targets the cell surface Mesothelin (MSLN). The precursor of MORAb-009 was isolated by Chowdhury et al in 1998 56 from a mouse splenic mRNA and was then optimized by fusing the gene encoding MSLN Fv (SS1 scFv) with human IgG1 and kappa regions. It was first designed to treat patients with mesothelin-positive cancers (pancreatic, ovarian, mesothelioma and lung). Amatuximab is not yet commercially available, and the highest development phase is Phase II. In addition, on 16 January 2014, orphan designation (EU/3/13/1222) was granted by the European Commission to Eisai Europe Limited, United Kingdom, for amatuximab for the treatment of malignant mesothelioma.