Catalog No.
KDD37501
Description
PRINCIPLE OF THE ASSAY This assay employs the quantitative competitive enzyme immunoassay technique. Recombinant Human CD33 has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled antibody and then pipetted into the wells. Lintuzumab in the sample competitively binds to the pre-coated protein with biotin-labeled Lintuzumab. 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 Lintuzumab 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 Lintuzumab concentration in serum and plasma.
Detection method
Colorimetric
Sample type
Plasma, Serum
Assay type
Quantitative
Range
78.13 - 5,000 ng/mL
Sensitivity
39.06 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) |
2593.7 |
680.7 |
164.3 |
2490.9 |
699.3 |
253.3 |
|
Standard deviation |
293.3 |
87.3 |
23.5 |
223.8 |
132.2 |
37.2 |
|
CV (%) |
11.3 |
12.8 |
14.3 |
9.0 |
18.9 |
14.7 |
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
225Ac-lintuzumab, HuM195, SGN-33, SMART M195, HuM195, CAS: 166089-32-3
Background
Lintuzumab is a humanized monoclonal antibody, HuM195, that targets the cell surface antigen CD33 that is expressed on the vast majority of acute myeloid leukemia (AML) cells. [225Ac]Ac-lintuzumab clinical trials were discussed in detail in reference. An initial phase I dose-escalation trial demonstrated that for a single infusion of [225Ac]Ac-lintuzumab in patients with relapsed or refractory acute myeloid leukemia, the maximum tolerated dose (MTD) was determined to be 111 kBq/kg with antileukemic activity across all dose levels. No evidence of radiation-induced nephrotoxicity was seen. Peripheral blasts were eliminated in 63% of the patients at doses of >37 kBq/kg. Bone marrow blast reduction was observed in 67% of patients. Subsequently, a multicenter phase I dose-escalation trial was conducted to define MTD, toxicity, and response rate of fractionated-dose [225Ac]Ac-lintuzumab when combined with low-dose cytarabine (LDAC) in older patients with untreated AML who were not candidates for intensive chemotherapy.
For research use only. Not for human or drug use.
