One Step Test for D-Dimer (Colloidal Gold)

Getein One Step Test for D-Dimer (Colloidal Gold) is used as an aid in the assessment and exclusion of suspected deep vein thrombosis (DVT) or pulmonary embolism (PE) in the Physical Department or emergency room (ER).
  • Test Item:

    D-Dimer
  • Sample Type:

    Plasma or Whole Blood in Sodium Citrate
  • Test Time:

    7 min
  • Methodology:

    Colloidal Gold

One Step Test for D-Dimer 

(Colloidal Gold)




Intended Use

The One Step Test for D-Dimer (colloidal gold) is intended for use together with the FIA8000 Quantitative Immunoassay Analyzer (FIA8000). The product employs colloidal gold immunochromatography to determine D-Dimer in human plasma, or whole blood specimens. This test is used as an aid in the assessment and exclusion of suspected deep vein thrombosis (DVT) or pulmonary embolism (PE) in the Physical Department or emergency room (ER).


About D-Dimer
D-Dimer is a marker of endogenous fibrinolysis and should therefore be detectable in patients with deep-vein thrombosis. In recent years, an increasing number of studies have shown the D-Dimer assay has a high negative predictive value and D-Dimer is a sensitive but nonspecific marker of deep-vein thrombosis. Negative D-Dimer can exclude deep-vein thrombosis and pulmonary embolism.


Contents

A box package contains 25 tests:

1) 25 Foil bags, which contains one test card and one desiccant

2) 25 Disposable pipets

3) 1 Manual

4) 1 SD card

5) 25 Sample diluents


Specifications


Product Name

Sample

Method

Storage Condition

One Step Test for D-Dimer 

(Colloidal Gold)

P/WB

ColloidalGold

4-30℃

Detection Range

Test Time

Cut-off Value

Shelf Life

0.1-10.0 mg/L

7 minutes.

0.5 mg/L


24 months




Applicable Device

Getein1100 Immunofluorescence Quantitative Analyzer

FIA8000 Quantitative Immunoassay Analyzer.


Clinical Application

1. As an aid in the exclusion of venous thromboembolism (VTE);

2. As an aid in the exclusion of pulmonary embolism(PE);

3. As an aid in the diagnosis of disseminated intravascular coagulation (DIC);

4. As an aid in the diagnosis and prognosis of cerebral infarction;

5. As an aid in the evaluation of coagulation status of pregnancy-induced hypertension;

6. As an aid in the diagnosis and prognosis of patients with surgery; monitor the thrombolytic therapy.

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