KRIBIOLISA Vedolizumab (ENTYVIO) ELISA

SKU: KBI1096

Rs 101,000.00

Enzyme Immunoassay for the estimation of Vedolizumab (ENTYVIO) 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%


The below Kit Insert is subject to change with the new lot of kits.

Availability: 3 – 4 Weeks | Pack Size: 1 x 96 wells




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Background:
Vedolizumab is a recombinant humanized IgG1 monoclonal antibody directed against the human lymphocyte 7 integrin, a key mediator of gastrointestinal inflammation. It is used in the treatment of moderate to severe active ulcerative colitis and Crohns disease for patients who have had an inadequate response with or lost response to, or were intolerant to inhibitors of tumor necrosis factor-alpha (TNF-alpha) or other conventional therapies. By blocking its primary target alpha beta 7 integrin, vedolizumab reduces inflammation in the gut.

Intended Use:
For Estimation of Vedolizumab (ENTYVIO) 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 Vedolizumab are pre-coated onto microwells. Samples and standards are pipetted into microwells and human Vedolizumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated anti-Vedolizumab 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 Vedolizumab 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

alpha4 7 integrin (gut homing)

Active Molecule / Modality

Vedolizumab – humanized IgG1 mAb; blocks 4 7

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

Vedolizumab

Species Cmax Value

not available

Dose & Regimen Reported

not available

Cmax (value + units)

Not reported in label/PI

Cmax Source (DOI/URL)

not available

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

Vedolizumab; ENTYVIO

Research Area

Immune molecule; Cell Biology; Immunology, Tumor