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| Product Name | Cancer Antigen 125 (CA125) Chemiluminescence Test Reagent |
| Catalog No. | TMTR-HMM-0050 |
| Description | A chemiluminescence immunoassay reagent formulated for the quantitative determination of CA125 antigen concentrations in human serum, intended for monitoring disease progression and therapeutic response in patients with ovarian carcinoma. |
| Intended Use | Quantitative serum CA125 measurement as an aid in monitoring ovarian cancer patients for treatment response and disease recurrence. |
| Principle / Technology | Sandwich immunoassay format employing two monoclonal antibodies that recognize distinct epitopes on the CA125/MUC16 glycoprotein, with paramagnetic microparticle solid-phase separation and acridinium ester chemiluminescent signal generation. |
| Detection Method | Fully automated chemiluminescence detection and quantification on a designated immunoassay analyzer |
| Sample Type | Human serum; specimens may be stored at 2–8°C for up to 48 hours or frozen at -20°C for extended storage; avoid repeated freeze-thaw cycles |
| Performance Range / Specifications | 0.6–5000 U/mL with automated dilution capability for outlier specimens |
| Sensitivity / LOD | Limit of detection: ≤0.5 U/mL; limit of blank: ≤0.3 U/mL |
| Specificity | Monoclonal antibodies specifically target the MUC16 extracellular domain; minimal cross-reactivity with other mucin glycoproteins and serum components at physiological concentrations |
| Reaction Conditions / Protocol | Fully automated two-step incubation protocol: 10-minute incubation of sample with capture antibody-coated microparticles and labeled detection antibody, followed by magnetic separation, wash, and chemiluminescent measurement; total assay time approximately 20 minutes |
| Components / Formulation | R1: paramagnetic microparticles coated with monoclonal anti-CA125 antibody, R2: acridinium ester-labeled monoclonal anti-CA125 detection antibody, assay buffer; calibrator set (6 levels); quality control materials (3 levels) |
| Storage Conditions | Upright storage at 2–8°C; reagent packs have on-board stability of 60 days; calibrators and controls are stable for 30 days after initial opening |
| Shelf Life | 18 months from the manufacturing date |
| Package Specifications | 200 tests per reagent pack |
| Product Form | Ready-to-use liquid reagent format in barcoded vials for automated analyzer integration |
| Quality Control | Calibrators traceable to an internal reference standard; three-level quality control sera provided with target values and acceptance ranges; inter-assay precision below 5% CV across the reportable range |
| Key Features | Extended dynamic range covering the clinically relevant CA125 spectrum without manual dilution; automated dilution protocol for concentrations exceeding 5000 U/mL; lot-to-lot reproducibility ensures reliable longitudinal monitoring of individual patients |
For research use only, not for clinical use.
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