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.
KRIBIOLISA Trastuzumab (HERCEPTIN) ELISA – Bound Drug
SKU: KBI1017-4
Rs 66,000.00
Enzyme Immunoassay for the estimation of bound Trastuzumab (HERCEPTIN) 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
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 – 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 | Trastuzumab; HERCEPTIN – Bound Drug |
| Research Area | Immune molecule; Cell Biology; Immunology, Tumor |
