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| Product Name | Thymidine Kinase 1 Activity Assay Kit (Chemiluminescence) |
| Catalog No. | TMTR-HMM-0079 |
| Description | A chemiluminescent assay kit for measuring thymidine kinase 1 enzymatic activity in serum as a proliferation biomarker. Elevated TK1 activity is associated with increased cell division and has utility in monitoring hematological malignancies and assessing tumor proliferation rate. The assay employs a nucleotide analog substrate that, upon phosphorylation by TK1, generates a luminescent signal proportional to enzyme activity levels. This format enables rapid, high-sensitivity measurement on standard luminometer instruments. |
| Intended Use | Quantitative determination of TK1 enzymatic activity in human serum for cell proliferation assessment in oncology applications. |
| Principle / Technology | Enzyme activity-linked chemiluminescent nucleotide analog phosphorylation |
| Detection Method | Chemiluminescence (flash-type signal) |
| Sample Type | Human serum; avoid hemolyzed samples |
| Performance Range / Specifications | Measuring range: 0.5–200 Du/L (Du = division unit) |
| Sensitivity / LOD | Detection limit: 0.2 Du/L |
| Specificity | Specific to TK1 isoform; no significant cross-reactivity with TK2 (mitochondrial thymidine kinase) |
| Reaction Conditions / Protocol | Sample volume: 10 µL; reaction time: 60 min at 25 °C; luminescence read: 1 sec integration |
| Components / Formulation | Nucleotide analog substrate solution, ATP cofactor, TK1 calibrator set (5 levels), control set (2 levels), reaction buffer, luminescence detection reagent |
| Storage Conditions | All reagents: –20 °C; thawed reagents stable for 2 weeks at 2–8 °C |
| Shelf Life | 12 months at –20 °C |
| Package Specifications | 96 tests |
| Product Form | Frozen liquid reagents in single-use aliquots |
| Quality Control | Calibrators traceable to recombinant human TK1 reference material; inter-lot consistency verified |
| Key Features | Flash-type luminescence signal simplifies single-injection luminometer operation; validated for hemato-oncology monitoring |
| Purity | Antibody purity ≥95% by SDS-PAGE; calibrator value assigned against reference standard |
| Concentration | As specified per kit format; calibrator concentrations traceable to internal reference |
| Activity / Unit Definition | Analytical sensitivity and measuring range as stated in IFU |
| Molecular Weight | Antigen-specific; varies per analyte as documented |
| Source / Origin | Monoclonal antibodies from murine hybridoma or recombinant expression; recombinant antigen standards |
| pH Range / Optimal pH | Optimal immunoreaction at pH 7.2–7.6 |
| Shipping Conditions | Cold packs; calibrators and controls may require frozen shipment |
| Expiration Date / Stability | 12–18 months at 2–8 °C; reconstituted calibrators stable per IFU |
| Regulatory / Compliance | For IVD use; manufactured under ISO 13485; CE-marked configurations available |
| Compatibility | Compatible with automated chemiluminescence, ELISA, and immunoturbidimetric platforms |
| Recommended Buffer System | PBS-based assay buffer; ProClin or sodium azide preservative |
| Application Notes / Precautions | Follow IFU for calibrator reconstitution; avoid repeated freeze-thaw; verify QC values within acceptable range before reporting results |
| Batch-to-Batch Consistency | Calibrator value assignment within ±10% of master reference; inter-lot CV ≤10% |
For research use only, not for clinical use.
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