KRIBIOLISA Alemtuzumab (LEMTRADA) ELISA

SKU: KBI1012

Rs 102,000.00

Enzyme Immunoassay for the estimation of Alemtuzumab (LEMTRADA) in serum and plasma. Key features: 1. Developed using highly specific monoclonal anti-idiotypic antibodies in a sandwich assay format 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

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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 MabCampath was withdrawn from the markets in the US and Europe in 2012 to prepare for a higher-priced relaunch of Lemtrada aimed at multiple sclerosis.

Intended Use:
For Estimation of Alemtuzumab (LEMTRADA) in human serum and plasma. Please note the kit has not been optimized to be used for any other animal species. Should you require a specific sera tested, please connect with us at sales@krishgen.com for optimization.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Alemtuzumab are pre-coated onto microwells. Samples and standards are pipetted into microwells and human Alemtuzumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated anti-Alemtuzumab antibody is pipetted and incubated. After washing microwells in order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the amount of Alemtuzumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.

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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 (LEMTRADA)

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 – 640 ng/ml

Standards Available

0; 10; 20; 40; 80; 160; 320; 640 ng/ml

Calibration Curve

6/8 point; standards available

Sensitivity

5 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

Alemtuzumab; LEMTRADA

Research Area

Immune molecule; Cell Biology; Immunology, Tumor

Documents

KRIBIOLISA Alemtuzumab-ELISA-Validation_Guide 2025_ver 1.0