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

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.