KRIBIOLISA Cetuximab (ERBITUX) ELISA – Bound Drug

SKU: KBI1018-2

Rs 82,500.00

Enzyme Immunoassay for the estimation of free and bound Cetuximab (ERBITUX) 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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All our kits are manufactured under ISO 13485.

Background:
Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor used for the treatment of metastatic colorectal cancer, metastatic non-small cell lung cancer and head and neck cancer. Cetuximab is a chimeric (mouse/human) monoclonal antibody given by intravenous infusion that is distributed under the trade name Erbitux in the U.S. and Canada by the drug company Bristol-Myers Squibb and outside the U.S. and Canada by the drug company Merck KGaA. In Japan, Merck KGaA, Bristol-Myers Squibb and Eli Lilly have a co-distribution. In July 2009, FDA approved Cetuximab (Erbitux) for treatment of colon cancer with wild-type KRAS, since it had little or no effect in colorectal tumors harboring a KRAS mutation (this also applied to the EGFR antibody panitumumab).

Intended Use:
For Estimation of Cetuximab (ERBITUX) 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.

Additional information

Target / Pathway

EGFR / ERBB1 pathway

Active Molecule / Modality

Cetuximab – chimeric IgG1 mAb; blocks EGFR

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

Cetuximab

Species Cmax Value

Adults with cancer (label PK)

Dose & Regimen Reported

400 mg/m? load 250 mg/m? weekly

Cmax (value + units)

Steady-state peak 168?235 ug/mL; trough 41?85 ug/mL

Cmax Source (DOI/URL)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125084s273lbl.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

Cetuximab; ERBITUX – Bound Drug

Research Area

Immune molecule; Cell Biology; Immunology, Tumor