Catalog No.
KDJ04001
Description
PRINCIPLE OF THE ASSAY This assay employs the quantitative competitive enzyme immunoassay technique. Recombinant Human CD276 has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled antibody and then pipetted into the wells. Enoblituzumab in the sample competitively binds to the pre-coated protein with biotin-labeled Enoblituzumab. 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 Enoblituzumab 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 Enoblituzumab concentration in serum and plasma.
Detection method
Colorimetric
Sample type
Plasma, Serum
Assay type
Quantitative
Range
312.5 - 20,000 ng/mL
Sensitivity
175.65 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) |
12437.0 |
3229.8 |
663.6 |
11936.3 |
3008.8 |
686.7 |
Standard deviation |
1033.4 |
251.1 |
52.0 |
1088.3 |
263.7 |
87.3 |
CV (%) |
8.3 |
7.8 |
7.8 |
9.1 |
8.8 |
12.7 |
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
MG-A271, , CAS: 1353485-38-7
Background
Enoblituzumab (also referred to as MGA271) is an Fc optimized humanized IgG1 monoclonal antibody that binds to B7-H3 (CD276), a member of the B7 family. This drug was developed by MacroGenics, Inc. that can be potentially used in the treatment of Solid tumors. Enoblituzumab is Fc-engineered with 5 amino acid substitutions to enhance binding to the activating FcγR and decrease binding to the inhibitory FcγR. Pre-clinical studies show that, in human CD16A-bearing transgenic mice, MGA271 exhibited potent antitumor activity in B7-H3–expressing xenograft models of renal cell and bladder carcinoma. To date, approximately 180 patients have received enoblituzumab monotherapy in a phase I study, with good tolerability. To determine the anti-tumor, immunological and biological effects of B7-H3 inhibition in high-risk localized pancreatic cancer, MacroGenics is currently conducting a neoadjuvant and pharmacodynamic phase II study.