Catalog No.
KDC09601
Description
PRINCIPLE OF THE ASSAY This assay employs the quantitative competitive enzyme immunoassay technique. Recombinant Human CD340 has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled antibody and then pipetted into the wells. Disitamab in the sample competitively binds to the pre-coated protein with biotin-labeled Disitamab. 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 Disitamab 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 Disitamab concentration in serum and plasma.
Detection method
Colorimetric
Sample type
Plasma, Serum
Assay type
Quantitative
Range
62.5 - 4,000 ng/mL
Sensitivity
43.24 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) |
2179.9 |
594.6 |
142.6 |
2360.7 |
584.5 |
146.7 |
|
Standard deviation |
272.7 |
112.7 |
14.2 |
388.2 |
47.2 |
22.1 |
|
CV (%) |
12.5 |
19.0 |
10.0 |
16.4 |
8.1 |
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
RC48-0, Disitamab Vedotin, CAS: 2185868-98-6
Background
Disitamab vedotin (Aidixi®) is an antibody-drug conjugate comprising a monoclonal antibody against human epidermal growth factor receptor 2 (HER2) conjugated via a cleavable linker to the cytotoxic agent monomethyl auristatin E. Disitamab vedotin is being developed by RemeGen for the treatment of solid tumours, including gastric cancer; Seagen has the right to develop disitamab vedotin globally outside of RemeGen's territory. In June 2021, disitamab vedotin received its first Biologics License Application (BLA) approval in China for the treatment of patients with HER2-overexpressing (defined as IHC2+ or 3+) locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) who have received at least two systemic chemotherapy regimens. Disitamab vedotin as monotherapy or combination therapy is also in clinical development for the treatment of other solid tumours globally, including urothelial cancer in China and the USA, and biliary tract cancer, non-small cell lung cancer and HER2-positive and HER2-low expressing breast cancer in China. This article summarizes the milestones in the development of disitamab vedotin leading to this first approval for locally advanced or metastatic gastric cancer.
For research use only. Not for human or drug use.
