D-Dimer Rapid Test Kit Medical Diagnostic Test Cassette Ce Certificate

For in vitro diagnostic use only 

Please read this package insert carefully prior to use and strictly follow the instructions. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.

INTENDED USE

Diagnostic Kit for D-Dimer(fluorescence immunochromatographic assay) is a fluorescence immunochromatographic assay for the quantitative detection of D-Dimer (D-D) in human plasma, it is used for the diagnosis of venous thrombosis, disseminated intravascular coagulation, and the monitoring of thrombolytic therapy .All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only.

SUMMARY

D-D reflects fibrinolytic function.The reasons for the increase of D-D:1.Secondary hyperfibrinolysis, such as hypercoagulation, disseminated intravascular coagulation, renal disease, organ transplant rejection, thrombolytic therapy, etc. 2.There are activated thrombus formation and fibrinolysis activities in vessels; 3.Myocardial infarction, cerebral infarction, pulmonary embolism, venous thrombosis, surgery, tumor,diffuse intravascular coagulation, infection and tissue necrosis, etc

PRINCIPLE OF THE PROCEDURE

The membrane of the test device is coated with anti D-D antibody on the test region and goat anti rabbit IgG antibody on the control region. Lable pad are coated by fluorescence labeled anti D-Dantibody and rabbit IgG in advance. When testing positive sample, the D-D antigen in sample combine with fluorescence labeled anti D-D antibody, and form immune mixture. Under the action of the immunochromatography, the complex flow in the direction of absorbent paper, when complex passed the test region, it combined with anti D-D coating antibody, forms new complex. D-D level is positively correlated with fluorescence signal, and the concentration of D-Din sample can be detected by fluorescence immunoassay assay.

REAGENTS AND MATERIALS SUPPLIED

25T package components:

Test card individually foil pouched with a desiccant25T

Sample diluents25T

Package insert1

MATERIALS REQUIRED BUT NOT PROVIDED

Sample collection container,timer

SAMPLE COLLECTION AND STORAGE

1. The samples tested can be heparin anticoagulant plasma or EDTA anticoagulant plasma.

2. According to standard techniques collect sample. Serum or plasma sample can be kept refrigerated at 2-8℃ for 7days and cryopreservation below -15°C for 6 months. 

3. All sample avoid freeze-thaw cycles.

ASSAY PROCEDURE

Please read the instrument operation manual and package insert before testing.

1. Lay aside all reagents and samples to room temperature.

2. Open the Portable Immune Analyzer(WIZ-A101), enter the account password login according to the operation method of the instrument, and enter the detection interface.

3. Scan the dentification code to confirm the test item.

4. Take out the test card from the foil bag.

5. Insert the test card into the card slot, scan the QR code, and determine the test item.

6. Add40μL serum or plasma sample to sample diluent, and mix well..

7. Add 80μL sample solution to sample well of the card.

8. Click the"standard test"button, after 15 minutes, the instrument will automatically detect the test card, it can read the results from the display screen of the instrument, and record/print the test results.

9. Refer to the instruction of Portable Immune Analyzer(WIZ-A101).