Diazyme Laboratories D-Dimer Assay

Diazyme D-Dimer Assay is for the quantitative determination of fibrinogen/fibrin degradation products (D-Dimer) in human plasma.

• 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
• Measurement of D-Dimer is used as an aid in detecting the presence of intravascular coagulation and fibrinolysis
• For in vitro diagnostic use only

Certifications/Compliance

510(k) Cleared, EU: CE IVD

Content And Storage

D-Dimer assay reagents, calibrators, and controls should be stored at 2 to 8°C. DO NOT FREEZE

Description

D-Dimer Assay Kit

CE Marker

Yes

Concentration

Lab dependent

Type

Diagnostic

Includes

R1 and R2

Linearity

Eleven levels of the D-Dimer linearity set were prepared by diluting a specimen containing 8.0 μg/mL FEU with saline according to Clinical and Laboratory Standards Institute EP6-A and tested on Modular P. Diazyme D-Dimer assay is linear from 0.15 to 8.0 μg/mL FEU.

Packaging Type

Universal

Stability

The reagents, calibrators, and controls are sta-ble when stored as instructed until the expiration date on the label. Open reagent bottles are stable for 4 weeks if stored on board the refrigerated compartment of the Roche Modular P analyzer.

Form

Liquid