D-Dimer Test
Diagnostic Kit for the Quantitative Determination of D-Dimer (Fluorescence Lateral Flow Immunoassay)
EU CE Mark. Not for home use.
Description
This kit is used for the in vitro quantitative detection of D-Dimer concentration in human plasma and whole blood samples.
D-Dimer is a specific degradation product produced by fibrin monomer crosslinked with activation factor and hydrolyzed by plasmin. Its formation and elevation reflect the activation of coagulation and fibrinolytic system of the body and are specific indicators of hypercoagulation and secondary fibrinolytic hyperactivity. The detection of D-Dimer has been applied to diffuse intravascular coagulation (DIC), deep venous thrombosis (DVT), pulmonary embolism (PE), cardiovascular disease and anticoagulation therapy.
This product should be used together with the fluorescence lateral flow immunoassay analyzer produced by Prometheus Bio Inc. It can be used in medical and healthcare institutions.
PRODUCT DETAILS
| Applicable Instrument: | NGFT-AC003 Prometheus SoloDx produced by Prometheus Bio Inc. |
| Sample: | Whole blood, serum, or plasma |
| Reference Ranges: | < 0.5 mg/L |
| Precision: | Intra-batch precision CV (%) ≤ 15%; Inter-batch precision CV (%) ≤ 15% |
| Accuracy: | Relative deviation is under ±15% |
| Linearity range: | 0.1-8 mg/L, the correlation coefficient r ≥ 0.99 |
| Lower Limit Detection (LLD): | ≤ 0.1 mg/L |
| No Cross-Reactivity: | 100 g/L albumin, 50 ng/mL Cardial Troponin I, 20000 pg/ mL N-terminal pro-B-type natriuretic peptide, 4000 IU/ mL rheumatoid factor |
| Interference Tolerance: | 40 mg/dL bilirubin, 1000 mg/dL triglyceride, hemoglobin, cholesterol |
| Storage: | Cool, dark and dry place at 4-30°C (Do not freeze) |
| Shelf-Life: | 18 Months |
| Packaging Specification: | 25 kits/box, 40 kits/box, 50 kits/box, 100 kits/box |
| Manufacturer: | Prometheus Bio Inc |
| Registration | CE Mark |
Additional information
| Box Count | 25 kits/box, 40 kits/box, 50 kits/box, 100 kits/box |
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| Registration |