Catalog No.
KDJ41001
Description
PRINCIPLE OF THE ASSAY This assay employs the quantitative competitive enzyme immunoassay technique. Recombinant Human NECTIN4 has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled antibody and then pipetted into the wells. Enfortumab in the sample competitively binds to the pre-coated protein with biotin-labeled Enfortumab. 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 Enfortumab 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 Enfortumab concentration in serum and plasma.
Detection method
Colorimetric
Sample type
Plasma, Serum
Assay type
Quantitative
Range
93.75 - 1,500 ng/mL
Sensitivity
47.39 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) | 692.6 | 160.3 | 91.4 | 652.4 | 163.6 | 95.8 |
Standard deviation | 47.1 | 12.0 | 14.9 | 80.2 | 27.9 | 18.1 |
CV (%) | 6.8 | 7.5 | 16.3 | 12.3 | 17.0 | 18.9 |
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%. For unopened kits, if you want to prolong the storage time, please store the Standard, Detection A, Detection B and Microplate at - 20℃, the rest reagents should be store at 4℃.
Alternative Names
AGS-22CE, AGS-22M, AGS-22M6E, unconjugated : AGS-22C3 or AGSM6, CAS: 1346452-25-2
Background
Enfortumab vedotin is an antibody-drug conjugate (ADC) designed for the treatment of cancer expressing Nectin-4. It was developed through two main lines, hybridoma (ASG-22ME) and Chinese hamster ovary (ASG-22CE). Enfortumab refers to the fully humanized (from mouse) monoclonal antibody (mAb) created by scientists at Agensys (part of Astellas) using Amgen’s transgenic system (XenoMouse), it is the first agent to target Nectin-4 that expressed on many solid tumors especially on bladder cancers. Vedotin refers to the payload drug microtubule-disrupting agent monomethyl auristatin E (MMAE) and the linker. The linker technology holding the antibody and the toxin together was provided by and licensed from Seattle Genetics. Preclinical studies showed that enfortumab vedotin effectively binds to target cells, internalizes and induces cell-killing activity. Mouse and patient xenograft models were used to test enfortumab vedotin’s antitumor activity in human breast, bladder, pancreatic and lung cancers. In March 2018, Seattle Genetics and Astellas received the U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for enfortumab vedotin based on interim results from the phase 1 study examining enfortumab vedotin as monotherapy treatment for patients with metastatic urothelial cancer who were previously treated with checkpoint inhibitors.
