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| Product Name | Thyroglobulin High-Sensitivity CLIA Kit |
| Catalog No. | TMTR-HMM-0058 |
| Description | A second-generation chemiluminescence immunoassay kit for the ultrasensitive measurement of thyroglobulin in serum, supporting post-thyroidectomy surveillance of differentiated thyroid cancer patients for residual or recurrent disease. |
| Intended Use | Quantitative thyroglobulin measurement in serum for post-thyroidectomy monitoring of differentiated thyroid carcinoma, enabling detection of residual thyroid tissue and disease recurrence at very low concentrations. |
| Principle / Technology | Sandwich CLIA using two monoclonal anti-thyroglobulin antibodies selected for high affinity and minimal interference from endogenous thyroglobulin autoantibodies. |
| Detection Method | Automated chemiluminescence detection |
| Sample Type | Human serum; concurrent measurement of thyroglobulin autoantibodies is recommended as TgAb interference may cause falsely low results |
| Performance Range / Specifications | 0.04–500 ng/mL; second-generation sensitivity enables detection without thyroxine withdrawal |
| Sensitivity / LOD | Functional sensitivity ≤0.04 ng/mL (defined as the concentration at which inter-assay CV is 20%) |
| Specificity | Monoclonal antibodies were selected through screening against a large panel of TgAb-positive sera to minimize antibody-mediated interference |
| Reaction Conditions / Protocol | Automated two-step protocol: 18-minute initial incubation of sample with capture antibody, wash, 10-minute incubation with detection antibody, total assay time approximately 30 minutes |
| Components / Formulation | Anti-Tg antibody-coated magnetic microparticles, acridinium ester-labeled anti-Tg detection antibody, assay buffer, Tg calibrators (0–500 ng/mL, 6 levels), Tg controls (3 levels) |
| Storage Conditions | 2–8°C; calibrators may be aliquoted and frozen at -20°C for extended storage |
| Shelf Life | 18 months |
| Package Specifications | 100 tests |
| Product Form | Ready-to-use liquid reagents |
| Quality Control | Calibrator traceability to CRM-457; functional sensitivity verified quarterly; inter-assay CV at 0.1 ng/mL below 10% |
| Key Features | Second-generation sensitivity supports unstimulated thyroglobulin monitoring; optimized antibody selection minimizes TgAb interference; lot-to-lot consistency supports reliable longitudinal patient tracking |
For research use only, not for clinical use.
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