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| Product Name | Carcinoembryonic Antigen (CEA) Chemiluminescence Immunoassay Reagent |
| Catalog No. | TMTR-HMM-0048 |
| Description | A fully automated chemiluminescence immunoassay reagent for the quantitative determination of carcinoembryonic antigen concentrations in human serum, supporting clinical monitoring of colorectal, pancreatic, gastric, and other epithelial-origin malignancies. |
| Intended Use | Quantitative measurement of CEA in serum as an adjunctive tumor marker for monitoring therapeutic response, detecting disease recurrence, and assessing prognosis in patients with adenocarcinomas. |
| Principle / Technology | Two-site sandwich chemiluminescence immunoassay utilizing a monoclonal capture antibody immobilized on paramagnetic microparticles and an acridinium ester-labeled monoclonal detection antibody directed against a separate CEA epitope. |
| Detection Method | Automated chemiluminescent detection and quantification on a compatible immunoassay analyzer platform |
| Sample Type | Human serum; specimens should be separated from the clot within 2 hours of collection; specimens may be stored at 2–8°C for up to 7 days or at -20°C for longer periods |
| Performance Range / Specifications | Reportable range: 0.5–1500 ng/mL with automatic sample dilution capability extending to 15000 ng/mL for specimens exceeding the upper limit |
| Sensitivity / LOD | Limit of blank: ≤0.2 ng/mL; functional sensitivity (lowest concentration with 20% inter-assay CV): ≤0.5 ng/mL |
| Specificity | The monoclonal antibody pair demonstrates high affinity and specificity for human CEA; cross-reactivity with NCA, BGP, and NCA-2 is below 0.1% at clinically relevant concentrations |
| Reaction Conditions / Protocol | Fully automated assay protocol: 18-minute total incubation time with sequential addition of sample, microparticle reagent, and labeled antibody reagent, followed by magnetic separation, wash, and chemiluminescent signal measurement |
| Components / Formulation | Ready-to-use liquid reagent packs containing paramagnetic particle suspension, acridinium ester-labeled antibody conjugate, and assay buffer; CEA calibrator set with 6 concentration levels; quality control materials at 2 concentration levels |
| Storage Conditions | Reagent packs stored upright at 2–8°C; on-board stability of 60 days on the automated analyzer; calibrators are stable for 30 days after opening when stored at 2–8°C |
| Shelf Life | 18 months from date of manufacture for unopened reagent packs stored at the recommended temperature |
| Package Specifications | 100 tests per reagent pack; calibrators and controls supplied in separate vials |
| Product Form | Ready-to-use liquid reagents in barcode-labeled vials compatible with automated analyzer reagent carousels |
| Quality Control | Calibrator values assigned by weight-based preparation and verified against the WHO International Reference Standard for CEA; inter-assay precision below 5% CV across the clinically relevant concentration range; lot-to-lot consistency verified by parallel testing |
| Key Features | Extended on-board stability reduces reagent waste and recalibration frequency; the broad dynamic range minimizes the need for manual sample dilution; barcode-labeled reagents enable automated inventory management and traceability on the analyzer |
For research use only, not for clinical use.
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