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| Product Name | HER2/neu (ErbB2) ELISA Kit, Quantitative, Extracellular Domain, Serum and Cell Lysate |
| Catalog No. | TMTR-HMM-0085 |
| Description | Sandwich ELISA kit for quantitative detection of human epidermal growth factor receptor 2 (HER2/neu, ErbB2, CD340) extracellular domain (ECD) in human serum and cell/tissue lysates. HER2 is a 185 kDa transmembrane receptor tyrosine kinase and member of the EGFR/ErbB family that is amplified and/or overexpressed in approximately 15-20% of breast cancers, 10-20% of gastric/gastroesophageal junction cancers, and subsets of ovarian, endometrial, lung, and colorectal cancers. HER2 overexpression drives aggressive tumor behavior and is the target of anti-HER2 therapies (trastuzumab, pertuzumab, trastuzumab emtansine/T-DM1, trastuzumab deruxtecan/T-DXd, lapatinib, neratinib, tucatinib). Elevated serum HER2 ECD levels (>15 ng/mL) correlate with tumor HER2 status, disease progression, metastasis, and therapeutic response, making it a useful research biomarker for monitoring HER2-positive cancers. |
| Intended Use | Quantitative measurement of HER2 extracellular domain in: human serum and plasma samples for correlative biomarker research; breast and gastric cancer cell line lysates (SK-BR-3, BT-474, AU565 as HER2+, MCF-7 as low, MDA-MB-231 as negative); tumor tissue lysates; xenograft tumor lysates; and drug response studies of anti-HER2 therapeutics. |
| Principle / Technology | Sandwich ELISA with two monoclonal antibodies recognizing distinct epitopes on the HER2 extracellular domain. Capture antibody (mouse anti-HER2 ECD, domain I/II) binds HER2 ECD. Detection antibody (biotinylated mouse anti-HER2 ECD, domain IV — distinct from trastuzumab binding site) binds a second epitope. Streptavidin-HRP and TMB produce colorimetric signal proportional to HER2 ECD concentration. Standard curve generated with recombinant HER2 ECD-Fc fusion protein. |
| Detection Method | Serum/plasma: dilute 1:10-1:50 in sample diluent; cell/tissue lysates: dilute to 0.5-2 mg/mL total protein; add 100 uL to wells; incubate 2 h RT; wash; detection antibody 1 h; wash; streptavidin-HRP 30 min; wash; TMB; stop; read A450; quantitate from standard curve. |
| Sample Type | Human serum (collect in serum separator tube, centrifuge, aliquot, store at -80 C); plasma (EDTA or citrate — heparin may interfere); cell lysates (HER2+ cell lines: SK-BR-3, BT-474, AU565); tissue lysates (fresh or frozen — FFPE-derived lysates may have reduced detection). |
| Performance Range / Specifications | Standard curve: 0.156-10 ng/mL; LOD: <0.1 ng/mL; serum HER2 ECD in healthy controls: 5-15 ng/mL (research context); HER2+ cancer patients: 15-500+ ng/mL; HER2 in SK-BR-3 cells: 50-200 ng/mg total protein. |
| Sensitivity / LOD | LOD <0.1 ng/mL (~0.5 pM for 185 kDa); serum dilution 1:10 yields effective LOD approximately 1 ng/mL in neat serum. |
| Specificity | Specific for human HER2 extracellular domain; <0.1% cross-reactivity with EGFR (ErbB1/HER1), ErbB3 (HER3), and ErbB4 (HER4) at 50 ng/mL. Does not cross-react with trastuzumab or pertuzumab (different epitope). |
| Reaction Conditions / Protocol | Incubations: capture 2 h RT, detection 1 h RT, HRP 30 min, TMB 15-30 min; total ~4-5 h. |
| Components / Formulation | Anti-HER2 ECD Coated 96-Well Plate, Recombinant HER2 ECD-Fc Standard (lyophilized), Biotinylated Anti-HER2 Detection Antibody (100x), Streptavidin-HRP (100x), Sample Diluent, Standard Diluent, Wash Buffer (20x), TMB, Stop Solution, Plate Sealers, Protocol. |
| Storage Conditions | Plate, diluents, wash, TMB, stop at 2-8 C; Standard, antibodies, HRP at -20 C; protect from light. |
| Shelf Life | 12 months. |
| Package Specifications | 96 determinations. |
| Product Form | Pre-coated strip plate; liquid reagents; lyophilized standard. |
| Quality Control | Standard R2 >0.99; LOD <0.1 ng/mL; intra-CV <8%; inter-CV <12%; serum spike recovery 85-115%; no EGFR/ErbB3/ErbB4 cross-reactivity. |
| Key Features | Quantitative HER2 ECD sandwich ELISA; validated for serum and cell lysate; distinct epitopes from therapeutic antibodies; recombinant HER2 ECD-Fc standard; 0.1 ng/mL sensitivity; strip plate format. |
| Purity | Antibodies >95%; standard >95% by SDS-PAGE; analytical grade reagents. |
| Concentration | Standard reconstitute to 10 ng/mL; antibodies 100x. |
| Activity / Unit Definition | Capture antibody Kd ~10^-10 M; detection antibody Kd ~10^-10 M; therapeutic antibody-free epitope (domain IV, distinct site). |
| Molecular Weight | HER2 full-length: ~185 kDa; ECD: ~105 kDa (aa 23-652); ECD-Fc standard: ~130 kDa (dimer). |
| Source / Origin | Recombinant monoclonal antibodies (animal-free); HER2 ECD-Fc standard from CHO cell expression; HRP plant-derived. |
| pH Range / Optimal pH | pH 7.2-7.4 optimal. |
| Shipping Conditions | Cold pack; antibodies and standard on dry ice. |
| Expiration Date / Stability | 12 months; reconstituted standard 1 week at 2-8 C or 3 months at -80 C. |
| Regulatory / Compliance | For research use only; not for diagnostic use. Not for HER2/neu status determination in clinical breast cancer management (IHC/FISH are the clinical gold standards). |
| Compatibility | Serum/plasma: dilute 1:10-1:50; cell/tissue lysates in RIPA (SDS <0.05% final). EDTA plasma preferred; heparin may cause high background in some lots. Avoid repeated freeze-thaw of serum samples. Protease inhibitors essential for tissue lysates. |
| Recommended Buffer System | PBS pH 7.4, 1% BSA, 0.05% Tween-20. |
| Application Notes / Precautions | Serum HER2 ECD levels correlate with tissue HER2 status but are not a substitute for IHC/FISH. Elevated levels are found in approximately 30-50% of metastatic HER2+ breast cancer patients. Serial monitoring can track disease progression and treatment response. For cell lysates: SK-BR-3 cells express very high HER2 levels (~10^6 receptors/cell), yielding strong signal at 1-5 ug lysate. Normalize cell/tissue results to total protein. The ELISA detects shed HER2 ECD, not intracellular domain. For trastuzumab-treated patients: this ELISA's detection antibody binds a different epitope and is not blocked by therapeutic antibodies at clinical concentrations. |
| Batch-to-Batch Consistency | Standard R2 >0.99; LOD <0.1 ng/mL; serum recovery 85-115%; inter-lot CV <15%. |
For research use only, not for clinical use.
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