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| Product Name | CA72-4 (Tumor-Associated Glycoprotein 72) ELISA Quantitative Detection Kit |
| Catalog No. | TMTR-HMM-0077 |
| Description | A solid-phase enzyme-linked immunosorbent assay kit for the quantitative measurement of CA72-4 antigen in human serum. CA72-4 is a high-molecular-weight mucin-like glycoprotein recognized by monoclonal antibodies B72.3 and CC49, elevated primarily in gastric adenocarcinoma and mucinous ovarian carcinoma. The assay employs a sandwich ELISA configuration with colorimetric detection suitable for manual and automated microplate processing. This kit provides all necessary reagents pre-calibrated for direct use. |
| Intended Use | Quantification of CA72-4 antigen level in serum specimens for adjunctive assessment of gastric and ovarian malignancies. |
| Principle / Technology | Sandwich enzyme-linked immunosorbent assay (ELISA) |
| Detection Method | Colorimetric (450 nm primary, 620 nm reference) |
| Sample Type | Human serum; avoid hemolyzed, lipemic, or icteric samples |
| Performance Range / Specifications | Calibration range: 0–200 U/mL; analytical measurement range: 1.5–200 U/mL |
| Sensitivity / LOD | Minimum detectable concentration: 0.6 U/mL; LoQ: 1.5 U/mL with CV ≤20% |
| Specificity | No cross-reactivity with CA125, CA19-9, CEA, or AFP above 0.05% |
| Reaction Conditions / Protocol | Sample volume: 50 µL/well; incubation: 60 min (capture) + 60 min (detection) + 15 min (substrate) at 37 °C |
| Components / Formulation | CA72-4 antibody-coated 96-well microplate, biotinylated detection antibody concentrate, streptavidin-HRP concentrate, CA72-4 standard set (6 concentrations), assay diluent, wash buffer (20×), TMB substrate solution, stop solution |
| Storage Conditions | All components at 2–8 °C; protect TMB substrate from light |
| Shelf Life | 12 months |
| Package Specifications | 96 tests |
| Product Form | Liquid reagents in dropper bottles; lyophilized standards |
| Quality Control | Each lot validated against a commercial reference panel; inter-assay CV ≤10%, intra-assay CV ≤8% |
| Key Features | Pre-coated break-apart strip format for flexible throughput; broad dynamic range reduces repeat testing |
| 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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