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| Product Name | PIVKA-II (Des-Gamma-Carboxy Prothrombin) Chemiluminescence Detection Reagent Set |
| Catalog No. | TMTR-HMM-0076 |
| Description | An in vitro diagnostic reagent system designed for the quantitative determination of protein induced by vitamin K absence or antagonist-II (PIVKA-II) in human serum or plasma specimens. The PIVKA-II protein serves as a sensitive serological marker for hepatocellular carcinoma surveillance and early detection. This reagent set contains calibrators, control materials, and detection components formulated for high-throughput automated immunoassay analyzers. The assay delivers precise and reproducible results through a two-site sandwich immunometric format with chemiluminescent signal generation. |
| Intended Use | Quantitative measurement of PIVKA-II concentration in serum or plasma to aid in the diagnosis and monitoring of hepatocellular carcinoma. |
| Principle / Technology | Two-site sandwich chemiluminescent immunoassay |
| Detection Method | Chemiluminescence |
| Sample Type | Human serum, EDTA or heparin plasma |
| Performance Range / Specifications | Measuring range: 5–75,000 mAU/mL; linearity deviation within ±10% across the dynamic range |
| Sensitivity / LOD | Analytical sensitivity: ≤3 mAU/mL; LoB ≤2 mAU/mL |
| Specificity | Minimal cross-reactivity with native prothrombin (less than 0.01%); no interference from warfarin therapy |
| Reaction Conditions / Protocol | Sample volume: 20 µL; incubation: 18 min at 37 °C; total assay time: approximately 30 min |
| Components / Formulation | Anti-PIVKA-II antibody-coated magnetic microparticles, acridinium ester-labeled anti-prothrombin conjugate, assay diluent, wash buffer concentrate, calibrator set (6 levels), control set (2 levels) |
| Storage Conditions | Unopened: 2–8 °C; reconstituted calibrators and controls: 2–8 °C for up to 4 weeks or –20 °C for up to 6 months |
| Shelf Life | 12 months from date of manufacture |
| Package Specifications | 100 test kit |
| Product Form | Liquid, ready-to-use reagent packs; lyophilized calibrators and controls |
| Quality Control | Calibrators traceable to an internal reference standard; QC targets assigned by replicate testing at three independent sites |
| Key Features | Monoclonal antibodies provide high epitope specificity for the abnormal des-gamma-carboxy form; liquid-ready reagent format minimizes handling errors |
| 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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