D-Dimer Fast Test Kit (Immunofluorescence Assay)

Getein D-Dimer Fast Test Kit is used as an aid in the assessment and evaluation of patients suspected of deep-vein thrombosis or pulmonary embolism.

  • Test Item:

    D-Dimer
  • Sample Type:

    Plasma or whole blood in Sodium Citrate
  • Test Time:

    10 min
  • Methodology:

    Immunofluorescence Assay

D-Dimer Fast Test Kit 

(Immunofluorescence Assay)




Intended Use

D-Dimer Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of D-Dimer in human plasma or whole blood samples. The test is used as an aid in the assessment and evaluation of patients suspected of deep-vein thrombosis or pulmonary embolism.


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

1. For Getein1100/ Getein1180

Package specifications: 25 tests/box, 10 tests/box

1) D-Dimer test card in a sealed pouch with desiccant
2) Disposable pipet
3) Sample diluent
4) User manual: 1 piece/box
5) SD card: 1 piece/box

2. For Getein1600

Package specifications: 2×24 tests/kit, 2×48 tests/kit:

1) Sealed cartridge with 24/48 Getein D-Dimer test cards
2) User manual: 1 piece/box
Materials required for Getein1600:
1) Sample diluent: 1 bottle/box
2) Box with pipette tips: 96 tips/box
3) Mixing plate: 1 piece/box

Note: Do not mix or interchange different batches of kits.


Specifications

Test Item

Sample

Detection Range

Storage Condition

D-Dimer

P/WB

0.1-10.0 mg/L

4-30℃

Method

Test Time

Cut-off Value

Shelf Life

Immunofluorescence

Assay

10 min

0.5 mg/L

24 months


Applicable Device

Getein1100 Immunofluorescence Quantitative Analyzer

Getein1180 Immunofluorescence Quantitative Analyzer

Getein1600 Immunofluorescence Quantitative 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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