Product Description
The BioDeviceLab’s Human Epidermal Growth Factor Receptor 2 (HER2/ErbB2) ELISA Kit is a high-performance enzyme-linked immunosorbent assay developed for the quantitative determination of Human Epidermal Growth Factor Receptor 2 in biological samples. Human Epidermal Growth Factor Receptor 2 is a transmembrane receptor tyrosine kinase that plays a central role in cell proliferation, differentiation, and survival signaling pathways. Overexpression or amplification of Human Epidermal Growth Factor Receptor 2 is strongly associated with aggressive tumor phenotypes, particularly in breast, gastric, and ovarian cancers.
Quantitative measurement of Human Epidermal Growth Factor Receptor 2 is widely used in oncology research to study tumor biology, evaluate therapeutic response to Human Epidermal Growth Factor Receptor 2–targeted agents, and investigate mechanisms of resistance. This assay combines high analytical sensitivity, excellent specificity, and robust reproducibility, making it suitable for routine laboratory research as well as advanced biodevice validation workflows.
Intended Use
This kit is intended for the quantitative determination of Human Epidermal Growth Factor Receptor 2 in:
• Serum
• Plasma
• Cell culture supernatants
• Tissue lysates
Applications include cancer biomarker research, Human Epidermal Growth Factor Receptor 2 signaling studies, therapeutic screening, drug response monitoring, organ-on-chip tumor models, and biodevice calibration and benchmarking.
Assay Principle
This assay employs a sandwich ELISA format:
• Human Epidermal Growth Factor Receptor 2 present in the sample binds to capture antibodies immobilized on a 96-well microplate.
• A biotinylated detection antibody recognizing a distinct Human Epidermal Growth Factor Receptor 2 epitope binds to the captured protein.
• An enzyme conjugate is added, followed by chromogenic substrate (TMB).
• The enzymatic reaction generates a colorimetric signal measured at 450 nm.
• Absorbance is directly proportional to the Human Epidermal Growth Factor Receptor 2 concentration in the sample.
Calibration Curve
• A calibration curve is generated using recombinant human Human Epidermal Growth Factor Receptor 2 standards with known concentrations.
• Mean absorbance values are plotted against Human Epidermal Growth Factor Receptor 2 concentration on a semi-logarithmic scale.
• A four-parameter logistic (4PL) regression model is recommended for curve fitting.
Analytical Performance
Dynamic detection range: 0.2 – 50 ng/mL
Limit of detection (LOD): ≤ 0.04 ng/mL
Intra-assay CV: < 8%
Inter-assay CV: < 10%
(Performance aligned with commercial Human Epidermal Growth Factor Receptor 2 ELISA kits used in oncology research.)
Selectivity & Specificity
The assay demonstrates high specificity for Human Epidermal Growth Factor Receptor 2 with minimal cross-reactivity. Representative specificity profile:
• Human Epidermal Growth Factor Receptor 2: 100%
• Epidermal Growth Factor Receptor (ErbB1), ErbB3, ErbB4: < 1%
• Unrelated growth factors and cytokines: < 1%
This specificity ensures accurate quantification of Human Epidermal Growth Factor Receptor 2 independent of related receptor family members.
Kit Components
Each kit contains sufficient reagents for up to 96 determinations:
• Antibody-coated 96-well microplate
• Recombinant human Human Epidermal Growth Factor Receptor 2 standards
• Biotinylated detection antibody
• Enzyme conjugate
• Assay buffer
• Wash buffer (10×)
• TMB substrate
• Stop solution
• Detailed assay protocol
Required Materials (Not Provided)
• Microplate reader capable of measuring absorbance at 450 nm
• Adjustable micropipettes and disposable tips
• Plate washer or manual washing equipment
• Plate shaker (recommended)
• Deionized or distilled water
Sample Collection & Handling
• Collect samples using standard laboratory procedures.
• Avoid repeated freeze–thaw cycles.
• Samples exceeding the highest standard should be diluted using assay buffer.
• Hemolyzed or lipemic samples may affect assay accuracy.
Quality Control
• Standards and controls should be included in each assay run.
• Duplicate measurements are recommended.
• Acceptance criteria should be defined according to experimental requirements.
BioDeviceLab applies quality-controlled reagent preparation and batch-to-batch consistency practices to support reproducibility and scalability for biodevice development.
Storage & Stability
• Store all components at 2–8 °C.
• Do not freeze reagents unless explicitly stated.
• Unopened kits are stable until the stated expiration date.
• Opened reagents should be handled according to protocol recommendations.
Limitations
• For research use only.
• Not intended for diagnostic or therapeutic procedures.
• Results should be interpreted within the context of experimental design and sample matrix.
Applications
• Breast and gastric cancer research
• Human Epidermal Growth Factor Receptor 2 signaling and pathway studies
• Drug discovery and therapeutic screening
• Tumor-on-chip and organ-on-chip models
• Biodevice calibration and benchmarking
