Catalog No.
KDB95901
Description
PRINCIPLE OF THE ASSAY This assay employs the quantitative competitive enzyme immunoassay technique. Recombinant Human CD4 has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled antibody and then pipetted into the wells. Ibalizumab in the sample competitively binds to the pre-coated protein with biotin-labeled Ibalizumab. 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 Ibalizumab 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 Ibalizumab concentration in serum and plasma.
Detection method
Colorimetric
Sample type
Plasma, Serum
Assay type
Quantitative
Range
125 - 8,000 ng/mL
Sensitivity
64.71 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) | 4179.9 | 986.7 | 225.1 | 4606.6 | 1239.3 | 280.7 |
Standard deviation | 216.3 | 51.6 | 25.4 | 511.3 | 178.4 | 33.0 |
CV (%) | 5.2 | 5.2 | 11.3 | 11.1 | 14.4 | 11.7 |
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
Hu5A8, TMB-355, TNX-355, CAS: 680188-33-4
Background
Ibalizumab, a recombinant humanized monoclonal antibody, represents the first novel agent for HIV-1 management in over a decade and is the first monoclonal antibody for the treatment of MDR HIV-1 infection in combination with other forms of antiretroviral therapy in heavily treatment-experienced adults who are failing their current antiretroviral regimen. Ibalizumab demonstrates a novel mechanism of action as a CD4-directed postattachment inhibitor and has a favorable pharmacokinetic profile that allows for a dosing interval of every 14 days after an initial loading dose. Clinical studies have demonstrated reasonably substantial antiretroviral activity with ibalizumab among a complex patient population with advanced HIV-1 infection who are receiving an optimized background regimen, where limited therapeutic options exist. Ibalizumab was well tolerated in clinical trials, and the most common adverse effects included diarrhea, nausea, dizziness, fatigue, pyrexia, and rash. Resistance to ibalizumab has also been observed via reduced expression or loss of the potential N-linked glycosylation sites in the V5 loop of the envelope glycoprotein 120. The mechanism of action, pharmacokinetic parameters, efficacy, and safety of ibalizumab present an advance in the management of MDR HIV-1 infection. Future studies and postmarketing experience will further determine longer-term clinical efficacy, safety, and resistance data for ibalizumab.
