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| Product Name | Human Epidermal Growth Factor Receptor 2 (HER2/neu) ELISA Kit |
| Catalog No. | TMTR-HMM-0069 |
| Description | A quantitative sandwich ELISA for measuring the extracellular domain of HER2/neu oncoprotein in human serum, supporting monitoring of HER2-positive breast cancer patients and assessment of HER2-targeted therapy response. |
| Intended Use | Quantitative serum HER2/neu ECD measurement for monitoring breast cancer patients, particularly those receiving HER2-targeted therapies. |
| Principle / Technology | Sandwich ELISA with monoclonal antibodies targeting two distinct epitopes on the HER2 extracellular domain. |
| Detection Method | Colorimetric at 450 nm |
| Sample Type | Human serum |
| Performance Range / Specifications | 0.5–250 ng/mL |
| Sensitivity / LOD | ≤0.2 ng/mL |
| Specificity | Specific for HER2 ECD; no cross-reactivity with EGFR, HER3, or HER4 at physiological concentrations |
| Reaction Conditions / Protocol | Three-hour total incubation: sample + detection antibody (2 hr at RT), followed by conjugate and development steps |
| Components / Formulation | Anti-HER2 antibody-coated microplate, HER2 ECD standard (6 levels), detection antibody, enzyme conjugate, TMB substrate, stop buffer, wash buffer |
| Storage Conditions | 2–8°C; standards at -20°C after reconstitution |
| Shelf Life | 12 months |
| Package Specifications | 96 tests |
| Product Form | Pre-coated plate format |
| Quality Control | Intra-assay CV below 6%; inter-assay CV below 8%; calibrated against recombinant HER2 ECD reference |
| Key Features | Non-invasive serum monitoring of HER2 status; validated for trastuzumab-treated patient monitoring; research use in evaluating HER2-targeted therapy pharmacodynamics |
For research use only, not for clinical use.
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