Background:
Alemtuzumab is a drug used in the treatment of chronic lymphocytic leukemia (CLL), cutaneous T-cell lymphoma (CTCL) and T-cell lymphoma under the trade names Campath, MabCampath and Campath-1H and in the treatment of multiple sclerosis as Lemtrada. It is also used in some conditioning regimens for bone marrow transplantation, kidney transplantation and islet cell transplantation. It is a monoclonal antibody that binds to CD52, a protein present on the surface of mature lymphocytes, but not on the stem cells from which these lymphocytes are derived. After treatment with alemtuzumab, these CD52-bearing lymphocytes are targeted for destruction. MabCampath was withdrawn from the markets in the US and Europe in 2012 to prepare for a higher-priced relaunch of Lemtrada aimed at multiple sclerosis. Anti-Drug Antibodies (ADA) may induce unwanted side effects in biopharmaceuticals. Hence, ADA has been subjected to increase in scrutiny by the regulatory authorities using immunogenicity safety studies. ADA has been observed in pre-clinical and clinical studies, resulting in significant changes in toxicology, pharmacokinetics and efficacy. These effects result from the generation of drug-induced (neutralizing) autoantibodies against Trastuzumab and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects Anti-Alemtuzmab antibodies and may be used for monitoring immunogenicity.
KRIBIOLISA Anti Alemtuzumab (LEMTRADA) ELISA
SKU: KBI2012
Rs 85,000.00
Enzyme Immunoassay for the quantitative determination of Anti-Alemtuzumab antibodies in serum, plasma and cell culture supernatant.
Key features:
1. Quantitative estimation of anti-drug antibodies
2. Validated as per international bioassay validation guidelines
3. Recovery: 80-120%
4. Precision CV <10%
Availability: 3 – 4 Weeks | Pack Size: 1 x 96 wells
Additional information
| Target / Pathway | CD52 / lymphocyte depletion |
|---|---|
| Active Molecule / Modality | Alemtuzumab – IgG1 mAb; depletes CD52+ lymphocytes |
| Pack Type | 1 x 96 wells, break-apart |
| Species Reactivity | Homo Sapiens (Human) |
| Sample Type | cell culture supernates and other biological fluids. For tear samples, cell lysates, plasma, pleas connect with us to optimize the kit accordingly., please connect with us to discuss further. Note the kit has been validated using human matrices only. For any other animal matrix, Serum, tissue homogenates |
| Analyte / Drug | Alemtuzumab |
| Species Cmax Value | Adults with MS (label) |
| Dose & Regimen Reported | 12 mg/day IV (5 days) initial course; 12 mg/day (3 days) second course |
| Cmax (value + units) | 3014 ng/mL (Day 5 initial); 2276 ng/mL (Day 3 second) |
| Cmax Source (DOI/URL) | https://www.ema.europa.eu/en/documents/product-information/lemtrada-epar-product-information_en.pdf |
| Sample Dilution | please refer to the most updated IFU enclosed with the kit supplied, Samples are to be diluted 1:1000 with the Sample Diluent provided in the kit. For more specific dilution instructions |
| Assay Range Cmax Value | 0 – 2000 ng/ml |
| Standards Available | 0; 31.25; 62.5; 125; 250; 500; 1000; 2000 ng/ml |
| Calibration Curve | 6/8 point; standards available |
| Sensitivity | 15 ng/ml |
| Interference | Preparations of the known factors were assayed for interference. No significant interference was observed. |
| Specificity | The assay uses anti idiotypic (humanized) antibody for capture and / or recombinant protein expressed in mamalian cells |
| Detection Method | Absorbance measured at 450nm, Colorimetric |
| Conjugate-Enzyme Reaction | Uses stable HRP Enzyme Conjugate with (single component) TMB Chromogenic Substrate for color development. |
| Shipping Temperature | Shipped at Room Temperature or in gel pack to maintain temperature at 2-8 degrees Celsius |
| Storage Temperature | if all the wells in the kit are not being used, store the unused wells in the foil pouch containing the desiccant pack, The kit (2-8 Degree Celsius) and its components are to be stored as indicated in the IFU (instructions for use). To ensure quality of your results |
| ELISA Type | Double Antibody, Sandwich ELISA |
| ELISA Interpretation | 4PL (2nd order) or Cubic Spline Graph. Software (MS Excel) available, on request, Quantitative Results Intepretation, to support interpretation of results. |
| Shelf Life Available | 8 -10 months at time of shipping |
| Alternate Names / Synonyms | Anti Alemtuzumab; LEMTRADA |
| Research Area | Immune molecule; Cell Biology; Immunology, Tumor |
