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| Product Name | Calcitonin CLIA Detection Kit |
| Catalog No. | TMTR-HMM-0064 |
| Description | A chemiluminescence immunoassay kit for the quantitative measurement of calcitonin in human serum. Calcitonin is the primary tumor marker for medullary thyroid carcinoma and is essential for post-thyroidectomy follow-up. |
| Intended Use | Quantitative calcitonin measurement for the diagnosis, staging, and long-term follow-up of medullary thyroid carcinoma. |
| Principle / Technology | Sandwich CLIA employing two monoclonal antibodies targeting distinct epitopes on the calcitonin molecule. |
| Detection Method | Automated chemiluminescence detection |
| Sample Type | Fasting human serum collected in plain tubes; calcitonin is susceptible to ex vivo degradation; specimens should be processed and frozen within 2 hours of collection |
| Performance Range / Specifications | 0.5–2000 pg/mL |
| Sensitivity / LOD | ≤0.5 pg/mL limit of detection |
| Specificity | High specificity for intact calcitonin (1-32); minimal cross-reactivity with procalcitonin and katacalcin at concentrations encountered in clinical practice |
| Reaction Conditions / Protocol | Automated two-step protocol with total assay time below 20 minutes |
| Components / Formulation | Anti-calcitonin antibody-coated magnetic microparticles, acridinium ester-labeled detection antibody, assay buffer, calcitonin calibrators (6 levels), controls (2 levels) |
| Storage Conditions | 2–8°C; calibrators should be used within 24 hours of opening |
| Shelf Life | 15 months |
| Package Specifications | 100 tests |
| Product Form | Ready-to-use liquid reagents |
| Quality Control | Calibrator traceability to synthetic human calcitonin; inter-assay precision below 5% CV; functional sensitivity verified quarterly |
| Key Features | High analytical sensitivity supports both basal and pentagastrin-stimulated calcitonin testing protocols; rapid turnaround for clinical decision-making |
For research use only, not for clinical use.
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