KRIBIOLISA Trastuzumab (HERCEPTIN) ELISA

SKU: KBI1017

Rs 54,000.00

Enzyme Immunoassay for the estimation of Trastuzumab (HERCEPTIN) in serum and plasma. Calibrated against internationally available WHO standard 19/108 from NIBSC.

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:
Trastuzumab is a humanized monoclonal antibody which targets Her-2/neu receptor. It binds to an extracellular domain of this receptor and inhibits HER2 homodimerization, thereby preventing HER2-mediated signaling. It may also upregulate cell cycle inhibitors such as p21 and p27. Trastuzumab is also thought to facilitate antibody-dependent cellular cytotoxicity, leading to the death of cells that express HER2. It is approved for use in treating breast cancers and is being tested for other cancers that overexpress HER2/neu. At the time of its FDA approval in 1998, Trastuzumab was among the first available “targeted” chemotherapies. It is currently indicated for HER2 breast cancers and HER2 positive gastric cancer.

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

HER2 / ERBB2 pathway

Active Molecule / Modality

Trastuzumab – IgG1 mAb; blocks HER2 signaling

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

Trastuzumab

Species Cmax Value

Adults (label PK)

Dose & Regimen Reported

4 mg/kg IV load then 2 mg/kg IV weekly; steady-state wks 16?32

Cmax (value + units)

Peak 123 ug/mL; trough 79 ug/mL (steady-state)

Cmax Source (DOI/URL)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.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

Trastuzumab; HERCEPTIN

Research Area

Immune molecule; Cell Biology; Immunology, Tumor