Accurex D-Dimer Fast Test Kit

Accurex D-Dimer Fast Test Kit 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.

Uses:
It 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.

Product Specifications and Features:

• It 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

• It has 25 tests

Directions For Use:

• Collect specimen according to manual

• Test card, sample and reagent should be brought to roomtemperatureprior to testing

• Confirm SD card lot No. in accordance with test kit lot No. Perform“SDCard Calib” calibration when necessary

• On the main interface of Getein1100, press "ENT" button to enter testinginterface

• Remove the test card from the sealed pouch immediately beforeuse. Label the test card with patient or control identification

• Put the test card on a clean table, horizontally placed

• Using sample transfer pipette, deliver 100 μl of sample into onetubeof sample diluent, mix gently and thoroughly. Then drop 100 μl (or 3dropsof sample when using disposable pipet) of sample mixture into thesampleport on the test card

• After 10 minutes, insert the test card into Getein1100 and press "ENT" button

• The result will be shown on the screen

Safety Information:

• For in vitro diagnostic use, only

• For professional use only

• Do not use the kit beyond the expiration date

• Do not use the test card if the foil pouch is damaged

• Do not open pouches until ready to perform the test

• Do not reuse the test card

• Do not reuse the pipet

• Handle all specimens as potentially infectious

• Proper handling anddisposal methods should be followed in accordance with local regulations

• Carefully read and follow the manual to ensure proper test performance