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| Product Name | CYFRA 21-1 Enzyme Immunoassay Kit |
| Catalog No. | TMTR-HMM-0059 |
| Description | An enzyme immunoassay for the quantitative detection of cytokeratin 19 fragment (CYFRA 21-1) in human serum, serving as a tumor marker for non-small cell lung cancer with particular utility in squamous cell carcinoma monitoring. |
| Intended Use | Quantitative CYFRA 21-1 determination in serum as a marker for non-small cell lung cancer monitoring and prognosis assessment. |
| Principle / Technology | Sandwich ELISA with two monoclonal antibodies (reacting with distinct epitopes on the soluble cytokeratin 19 fragment) and a streptavidin-biotin detection system. |
| Detection Method | Colorimetric measurement at 450/620 nm |
| Sample Type | Human serum; skin contact during venipuncture should be avoided as epidermal contamination can cause falsely elevated readings |
| Performance Range / Specifications | 0.5–100 ng/mL; the 95th percentile reference value in healthy individuals is approximately 3.3 ng/mL |
| Sensitivity / LOD | ≤0.1 ng/mL analytical sensitivity |
| Specificity | Specific for the soluble fragment of cytokeratin 19; no reactivity with intact cytokeratin filaments or other intermediate filament proteins |
| Reaction Conditions / Protocol | Two-hour total protocol: simultaneous incubation of sample and detection antibody for 60 minutes at room temperature, followed by washing and sequential enzyme conjugate and substrate development steps |
| Components / Formulation | Streptavidin-coated 96-well microplate, biotinylated monoclonal capture antibody, HRP-conjugated detection antibody, CYFRA 21-1 standard set (6 levels), TMB substrate, stop solution, 20× wash buffer, assay diluent |
| Storage Conditions | 2–8°C; reconstituted standard at 2–8°C for 7 days or -20°C for 30 days |
| Shelf Life | 12 months |
| Package Specifications | 96 tests |
| Product Form | Coated microplate format with liquid reagents |
| Quality Control | Intra-assay CV below 5%; inter-assay CV below 8%; spike recovery between 85% and 115% |
| Key Features | Streptavidin-coated plate provides flexibility for biotin-based assay systems; established reference range available for clinical interpretation; validated for longitudinal patient monitoring in thoracic oncology |
For research use only, not for clinical use.
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