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Product Features

Diazyme's D-Dimer Assay is a highly sensitive liquid stable latex enhanced immunoturbidimetric test kit, designed to work on most open clinical chemistry analyzers to provide rapid results with reduced reagent cost. The D-Dimer Assay has a linearity of 0.15 - 8.0 μg/mL FEU with a correlation coefficient value of 0.939, slope of 0.979 and y intercept of -0.106. The following substances do not interfere with this assay at the levels tested less than 10% bias: Hemoglobin up to 500 mg/dL, Bilirubin 40 mg/dL, Bilirubin conjugated 40mg/dL, Triglycerides 1000 mg/dL, Ascorbic Acid 176 mg/dL, Rheumatoid Factor 100 IU/mL, Heparin 1.5 IU/mL and HAMA 490 ng/mL.

Assay Principle

Diazyme's D-Dimer Assay is based on a latex enhanced immunoturbidimetric assay. D-Dimer proteins in the sample bind to the specific anti-D-Dimer antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of D-Dimer in the sample. The Roche™ Modular P calculates the D-Dimer concentration of a patient specimen by interpolation of the obtained signal of a 6-point calibration curve.

Intended use

Diazyme's D-Dimer Assay is for the quantitative determination of fibrinogen/fibrin degradation products (D-Dimer) in human plasma. Measurement of D-Dimer is used as an aid in detecting the presence of intravascular coagulation and fibrinolysis. For in vitro diagnostic use only.

Product Catalog Number Format Method
Kit DZ179A R1/R2 (Dual Vial Liquid Stable) Dual Vial Liquid Stable,
Calibrator DZ179A-Cal Cal: 5 Level (Lyophilized)  
Control DZ179A-Con Con: 2 Level (Lyophilized)  
Regulatory Status