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| Product Name | CA15-3 Breast Cancer Marker CLIA Kit |
| Catalog No. | TMTR-HMM-0052 |
| Description | A chemiluminescence immunoassay kit for the quantitative detection of CA15-3 antigen in human serum, supporting clinical decision-making in the longitudinal monitoring of patients diagnosed with breast carcinoma. |
| Intended Use | Quantitative measurement of serum CA15-3 levels as a tumor marker for monitoring breast cancer patients, including detection of recurrence and evaluation of therapeutic response. |
| Principle / Technology | Sandwich immunoassay format utilizing two monoclonal antibodies directed against distinct epitopes on the MUC1 glycoprotein, with chemiluminescent signal generation for sensitive detection. |
| Detection Method | Automated chemiluminescence detection on a compatible immunoassay analyzer |
| Sample Type | Human serum; EDTA plasma may be acceptable after local validation; specimens containing visible fibrin strands or particulate matter should be clarified by centrifugation before testing |
| Performance Range / Specifications | 0.5–800 U/mL analytical measurement range with automated dilution for samples exceeding the upper limit |
| Sensitivity / LOD | Limit of blank: ≤0.3 U/mL |
| Specificity | The dual-monoclonal design ensures selective recognition of the tumor-associated MUC1 isoform; interference from benign breast conditions, pregnancy, and liver disease is acknowledged and should be considered during clinical interpretation |
| Reaction Conditions / Protocol | Automated sequential addition of sample and reagent: initial incubation with capture antibody-coated microparticles for 10 minutes, followed by addition of labeled detection antibody and a second 10-minute incubation, then magnetic separation, wash, and chemiluminescent measurement; total time approximately 22 minutes |
| Components / Formulation | R1: streptavidin-coated magnetic microparticles, R2: biotinylated anti-CA15-3 capture antibody, R3: acridinium ester-labeled anti-CA15-3 detection antibody; calibrator set with 6 levels; tri-level quality control material |
| Storage Conditions | Store all reagents at 2–8°C; do not freeze; protect calibrators and controls from prolonged exposure to light; on-board reagent stability of 60 days on the automated platform |
| Shelf Life | 18 months for unopened reagent packs when stored at recommended temperature |
| Package Specifications | 100 tests per reagent pack set |
| Product Form | Ready-to-use liquid reagents with barcode identification for automated tracking |
| Quality Control | Calibrator values assigned by weight-based preparation and verified against an internal reference standard; three-level controls monitor both the low, medium, and high ranges of the assay; inter-assay CV typically below 4% across the full reportable range |
| Key Features | Short 22-minute turnaround time accommodates high-throughput clinical laboratory workflows; the dual-epitope design ensures consistent detection of MUC1 variants; barcode identification enables efficient reagent loading and inventory management on automated systems |
For research use only, not for clinical use.
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