D-二聚体
PDB ID: 2Q9I. Source: RCSB Protein Data Bank. For illustration purposes only.
VeriLumenTM D-二聚体
The VeriLumenTM D-Dimer Rapid Test is a fluorescence immunochromatographic assay for the quantitative detection of D-dimer in human whole blood or plasma samples. D-dimer is a fibrin degradation fragment produced during clot formation and breakdown, and elevated levels reflect activation of coagulation and fibrinolytic pathways. The assay provides rapid quantitative results to support timely clinical evaluation in laboratory and point-of-care settings.
This test is mainly used in the clinical assessment of coagulation and thrombotic disorders, including disseminated intravascular coagulation (DIC), and is also valuable in the evaluation of suspected venous thromboembolism such as deep vein thrombosis (DVT) and pulmonary embolism (PE), helping to support clinical decision pathways. It may additionally be used in the monitoring of thrombolytic therapy. Quantitative D-dimer measurement supports clinical interpretation when considered alongside other laboratory and clinical findings.
| Ref. Code | 808167 |
| Analyte | D-二聚体 |
| Format | Fluorescence lateral flow immunoassay (cassette format) |
| Diagnostic Readout | Quantitative |
| Time to Result | 10 minutes |
| Measuring Range | 0.05–10 mg/L |
| Reference Value | 0.5 mg/L | R2 | ≥ 0.95 |
| Storage Conditions | 2–30°C |
| Shelf Life | 18 months |
| Certificate | CE, NMPA |
| Sample Types | Human whole blood, plasma or serum |
| Sample Volume | 100μL |
| Collection Method | Venous blood |
| Sample Stability | Stable for testing within 1 hour at room temperature (as validated) |
| Acceptable Anticoagulants | EDTA / Heparin / Citrate (as applicable) |
| Notes on Handling | Specimens should be collected and handled using standard laboratory procedures. Use fresh samples when possible and avoid hemolyzed, lipemic, or contaminated specimens. |
| Detection Method | Quantitative fluorescence immunochromatography |
| Antibody Format | Monoclonal / sandwich |
| Signal Generation | Fluorescence signal (fluorescent-labeled immunochromatography) |
| Reading Method | Instrument-based |
| Mechanism | The assay is based on a fluorescence immunochromatographic sandwich principle, in which D-dimer present in the sample binds to specific fluorescently labeled anti–D-dimer antibodies during capillary migration along the membrane. The resulting antigen–antibody complexes are captured by immobilized antibodies at the test region, and the fluorescence signal is measured and correlated with the D-dimer concentration in the specimen. |
| Tests per Kit | 10/25/50 Tests |
| Dimension of Kit Box | 21 × 13.5 × 8 cm |
| Kits per Carton | 48 Kits |
| Tests per Carton (Bulk) | 1200 Tests |
| G.W. per Carton (Boxed) | 23.2 kg |
| G.W. per Carton (Bulk) | 26.2 kg |
| Carton Dimension | 67 × 57.5 × 39 cm |
| Carton Volume | 0.15 CBM |
| Packaging Format | Individual sealed test kits / bulk configuration (as applicable) | Items Included | - Test cassette - Desiccant- Sample diluent- ID chip- Instructions for Use |
| Storage & Shipping Conditions | Standard ambient transport; store according to product label requirements |
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