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| Product Name | CEA Sandwich ELISA Quantitative Detection Kit |
| Catalog No. | TMTR-HMM-0049 |
| Description | An enzyme-linked immunosorbent assay for the quantitative measurement of carcinoembryonic antigen in human serum and plasma, suitable for clinical laboratories performing batch testing for gastrointestinal cancer monitoring. |
| Intended Use | Laboratory-based quantitative determination of CEA in serum and plasma as a tumor marker for colorectal and other gastrointestinal cancer patient management. |
| Principle / Technology | Solid-phase sandwich ELISA employing a biotin-streptavidin signal enhancement system with monoclonal antibodies targeting two discrete epitopes on the CEA glycoprotein. |
| Detection Method | Spectrophotometric measurement at 450 nm with reference wavelength correction at 570 nm for optical density normalization |
| Sample Type | Human serum or plasma collected with EDTA or heparin anticoagulant |
| Performance Range / Specifications | Standard curve range: 0.78–50 ng/mL; five-parameter logistic curve fitting recommended for accurate quantitation |
| Sensitivity / LOD | Minimum detectable concentration: ≤0.3 ng/mL, calculated as the mean signal of 20 zero-standard replicates plus 3 standard deviations |
| Specificity | Antibody pair shows <0.05% cross-reactivity with non-specific cross-reacting antigen (NCA), biliary glycoprotein (BGP), and other CEA gene family members |
| Reaction Conditions / Protocol | Add 100 μL of standard or diluted sample to each well, incubate at 37°C for 60 minutes, wash plates five times, add 100 μL detection antibody and incubate for 60 minutes, wash, add 100 μL streptavidin-HRP and incubate for 30 minutes, wash, develop with TMB for 15 minutes protected from light, stop the reaction and read absorbance |
| Components / Formulation | Anti-CEA antibody pre-coated 96-well microplate strips, lyophilized CEA standard (reconstitute to 50 ng/mL), biotinylated detection antibody concentrate, streptavidin-HRP conjugate concentrate, TMB chromogen solution, stop solution, 20× wash buffer concentrate, assay diluent, plate sealing film |
| Storage Conditions | Unopened kit at 2–8°C; reconstituted standard is stable for 7 days at 2–8°C or up to 30 days at -20°C when aliquoted; all other components are stable until the printed expiration date |
| Shelf Life | 12 months from the date of manufacture |
| Package Specifications | 96 tests (12 × 8-well strips in a break-apart frame) |
| Product Form | Pre-coated microplate with concentrated liquid reagents to be diluted before use |
| Quality Control | Intra-assay precision CV below 6% as determined by 20 replicate measurements of three serum pools spanning low, medium, and high concentrations; inter-assay precision below 8%; dilution linearity between 90% and 110% of expected values |
| Key Features | The biotin-streptavidin detection system provides signal amplification comparable to chemiluminescence methods while using standard colorimetric detection equipment; pre-coated plates produced under controlled conditions ensure well-to-well uniformity |
For research use only, not for clinical use.
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