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| Product Name | Human Chorionic Gonadotropin (hCG) CLIA Kit |
| Catalog No. | TMTR-HMM-0057 |
| Description | A chemiluminescence immunoassay kit for the quantitative measurement of total human chorionic gonadotropin in serum and plasma. Beyond pregnancy testing, hCG serves as a tumor marker for gestational trophoblastic disease and testicular germ cell tumors. |
| Intended Use | Quantitative measurement of total hCG in serum and plasma for pregnancy diagnosis, monitoring of trophoblastic disease, and detection of testicular germ cell tumors. |
| Principle / Technology | Sandwich CLIA with antibodies binding to distinct epitopes on both the alpha and beta subunits of the hCG molecule, ensuring detection of intact hCG, nicked hCG, and free beta subunit. |
| Detection Method | Automated chemiluminescence detection |
| Sample Type | Human serum or lithium heparin plasma; specimens should be tested within 24 hours at 2–8°C or frozen at -20°C |
| Performance Range / Specifications | 0.1–10000 mIU/mL with automatic 1:10 and 1:100 dilution protocols for high-level specimens |
| Sensitivity / LOD | ≤0.1 mIU/mL limit of blank |
| Specificity | Dual-subunit antibody design ensures broad recognition of hCG variants; cross-reactivity with LH, FSH, and TSH is below 0.01% at peak physiological concentrations |
| Reaction Conditions / Protocol | Fully automated one-step sandwich format: 18-minute total incubation, magnetic particle separation, wash, and chemiluminescent detection |
| Components / Formulation | Magnetic particle reagent, acridinium ester-labeled antibody reagent, assay buffer, calibrator set (6 levels), control set (3 levels) |
| Storage Conditions | 2–8°C; calibrators stable for 30 days after opening |
| Shelf Life | 18 months |
| Package Specifications | 200 tests per reagent pack |
| Product Form | Ready-to-use liquid reagents |
| Quality Control | Calibrators traceable to the WHO 5th International Standard for hCG (07/364); inter-assay CV below 5%; high-dose hook effect eliminated up to 750,000 mIU/mL |
| Key Features | Ultra-wide dynamic range with automatic dilution; hook effect protection for oncology applications; dual utility for pregnancy and tumor marker testing |
For research use only, not for clinical use.
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