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| Product Name | Circulating Tumor Cell Enrichment and Detection Kit (Immunomagnetic Separation) |
| Catalog No. | TMTR-HMM-0078 |
| Description | A cell enrichment system for isolating and enumerating circulating tumor cells from whole blood specimens. The reagent set utilizes antibody-conjugated magnetic nanoparticles targeting epithelial cell surface markers for positive selection, followed by fluorescent immunostaining for identification and enumeration. This kit is applicable to research use in cancer prognosis evaluation, therapy monitoring, and minimal residual disease assessment. The workflow is compatible with manual processing and select automated cell separation platforms. |
| Intended Use | Enrichment and identification of epithelial-origin circulating tumor cells from peripheral blood samples for downstream cytological and molecular analysis. |
| Principle / Technology | Immunomagnetic positive selection with multi-parameter immunofluorescence confirmation |
| Detection Method | Fluorescence microscopy or automated scanning cytometry |
| Sample Type | Whole blood collected in EDTA or CellSave preservative tubes; process within 24 hours of collection |
| Performance Range / Specifications | Recovery rate: ≥80% for EpCAM-positive cell lines spiked into normal donor blood at 5–500 cells per 7.5 mL |
| Sensitivity / LOD | Detection limit: approximately 1 CTC per 7.5 mL blood |
| Specificity | EpCAM-based enrichment captures epithelial tumor cells; excludes CD45-positive leukocytes; confirmed with cytokeratin positivity and DAPI nuclear staining |
| Reaction Conditions / Protocol | Blood volume: 7.5 mL; magnetic incubation: 45 min at room temperature; staining: 30 min at room temperature |
| Components / Formulation | Anti-EpCAM magnetic nanoparticle suspension, leukocyte depletion cocktail, permeabilization buffer, anti-cytokeratin-FITC antibody, anti-CD45-PE antibody, DAPI nuclear stain, wash buffer concentrate, mounting medium |
| Storage Conditions | Nanoparticles and antibodies: 2–8 °C; buffers: room temperature; protect fluorescent reagents from light |
| Shelf Life | 12 months for antibodies and nanoparticles; 18 months for buffers |
| Package Specifications | 24-test kit |
| Product Form | Liquid reagents; antibodies supplied as pre-diluted ready-to-use solutions |
| Quality Control | Each lot tested with EpCAM-positive control cell lines spiked into donor blood; recovery within specification |
| Key Features | Closed-tube magnetic separation step reduces shear stress on cells; compatible with downstream single-cell sequencing workflows |
| Purity | Antibody purity ≥95% by SDS-PAGE; calibrator value assigned against reference standard |
| Concentration | As specified per kit format; calibrator concentrations traceable to internal reference |
| Activity / Unit Definition | Analytical sensitivity and measuring range as stated in IFU |
| Molecular Weight | Antigen-specific; varies per analyte as documented |
| Source / Origin | Monoclonal antibodies from murine hybridoma or recombinant expression; recombinant antigen standards |
| pH Range / Optimal pH | Optimal immunoreaction at pH 7.2–7.6 |
| Shipping Conditions | Cold packs; calibrators and controls may require frozen shipment |
| Expiration Date / Stability | 12–18 months at 2–8 °C; reconstituted calibrators stable per IFU |
| Regulatory / Compliance | For IVD use; manufactured under ISO 13485; CE-marked configurations available |
| Compatibility | Compatible with automated chemiluminescence, ELISA, and immunoturbidimetric platforms |
| Recommended Buffer System | PBS-based assay buffer; ProClin or sodium azide preservative |
| Application Notes / Precautions | Follow IFU for calibrator reconstitution; avoid repeated freeze-thaw; verify QC values within acceptable range before reporting results |
| Batch-to-Batch Consistency | Calibrator value assignment within ±10% of master reference; inter-lot CV ≤10% |
For research use only, not for clinical use.
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