About
AccuDx D-Dimer Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of D-Dimer in plasma or whole blood. The test is used as an aid in the assessment and evaluation of patients suspected of deep-vein thrombosis or pulmonary embolism.
SUMMARY
Deep-vein thrombosis is a common condition, with a lifetime cumulative incidence of 2 to 5 percent. Untreated deep-vein thrombosis can result in pulmonary embolism, a potentially fatal outcome. Anticoagulant therapy reduces both morbidity and mortality from venous thromboembolism, and early diagnosis is therefore important. Accurate diagnosis of deep-vein thrombosis minimizes the risk of thromboembolic complications and averts the exposure of patients without thrombosis to the risks of anticoagulant therapy.
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
TEST RESULTS
Getein1100 can scan the test card automatically and display the result on the screen. Please follow the procedure in user manual of Getein1100 for result printing.
For additional information, please refer to the user manual of Getein1100.
Specification
The test uses an anti-human D-Dimer monoclonal antibody conjugated with fluorescence latex and another anti-human D-Dimer monoclonal antibody coated on the test line. After the sample has been applied to the test strip, the fluorescence latex-labelled anti-human D-Dimer monoclonal antibody binds with the D-Dimer in sample and forms a marked antigen-antibody complex. This complex moves to the test card detection zone by capillary action. Then marked antigen-antibody complex is captured on the test line by another anti-human D-Dimer monoclonal antibody. The fluorescence intensity of the test line increases in proportion to the amount of D-Dimer in sample. Then insert test card into Getein1100 Immunofluorescence Quantitative Analyzer (hereafter referred to as Getein1100), the concentration of D-Dimer in sample will be determined and displayed on the screen. The value will be stored in Getein1100 and available for downloading. The result can be easily transmitted to the laboratory or hospital information system.
Direction for Use
1. Collect specimen according to manual.
2. Test card, sample and reagent should be brought to room temperature prior to testing.
3. Confirm SD card lot No. in accordance with test kit lot No.. Perform “SDCard Calib” calibration when necessary (Details refer to 8.5.2of Getein1100 User Manual).
4. On the main interface of Getein1100, press “”ENT”” button to enter testing interface.
5. Remove the test card from the sealed pouch immediately before use. Label the test card with patient or control identification.
6. Put the test card on a clean table, horizontally placed.
7. Using sample transfer pipette, deliver 100 μl of sample into one tube of sample diluent, mix gently and thoroughly. Then drop 100 μl (or 3dropsof sample when using disposable pipet) of sample mixture into the sample port on the test card.
8. After 10 minutes, insert the test card into Getein1100 and press “”ENT”” button. The result will be shown on the screen
Other Info
Store the test card at 4~30oC with a valid period of 24 months.
Use the test card within 1 hour once the foil pouch is opened.
Store the blood sample diluent at 0~30oC with a valid period of 24 months.
Store the blood sample diluent at 2~8oC for better results.”
Khalid Ansari –
Using it for ddimer blood tests from last 3 years