Description

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Background

The Human D-Dimer CLIA Kit is designed, developed, and produced for the quantitative measurement of human D-Dimer level in serum samples. The assay utilizes a two-site “sandwich” technique with two antibodies that bind to different epitopes of D-Dimer. Assay calibrators, controls, or patient serum samples are added directly to a reaction vessel together with streptavidin coated magnetic particles, acridinium ester conjugated D-Dimer monoclonal antibody and biotinylated anti- D-Dimer polyclonal antibody. The magnetic particles capture the biotin antibody as well as an immune-complex in the form of “magnetic particles–biotin D-Dimer antibody–D-Dimer– acridinium ester D-Dimer antibody”. Materials bound to the solid beads are held in a magnetic field while unbound materials are washed away. Then trigger solutions are added to the reaction vessel, and light emission is measured with the ECL100 analyzer. The relative light units (RLU) are proportional to the concentration of a D-Dimer in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve and reported in serum D-Dimer concentration.

Selected Literature

​​​​​​​1.Becker DM, Philbrick JT, Bachhuber TL, et,al. D-dimer testing and acute venous thromboembolism, Arch Intern Med. 1996;156: 939-46.
2.Bonameaux H, Schneider PA, Reber G, et,al. Measurement of plasma D-dimer for diagnosis of deep venous thrombosis. Am J ClinPathol.1989; 91: 82-5.
​​​​​​​3.Shitrit D, Heyd J, Raveh D, et,al. Diagnostic value of the Ddimer test in deep vein thrombosis improved results by a new assay method and by using discriminate levels. Thromb Res. 2001;102:125-31.

For in-vitro diagnostic use.