D-Dimer CLIA Test CE

The D-Dimer Chemiluminescence ImmunoAssay (CLIA) Test is a chemiluminescence-based immunoassay for the quantitative detection of DDimer in human plasma (Lithium heparin, EDTA, citrate) or whole blood using the ALTA CLIAlyzer.

D-Dimer is the fibrinolysis-specific degradation product found in human blood. D-Dimer is not normally present in human blood, except when the coagulation system has been activated, for instance because of the presence of thrombosis or disseminated intravascular coagulation. Therefore, D-Dimer is commonly used to exclude thromboembolic disease where the probability is low. A positive result can indicate thrombosis but does not rule out other potential causes.

In addition, D-Dimer is used in the diagnosis of blood disorders disseminated by intravascular coagulation. Myocardial infarction, cerebral infarction, pulmonary embolism, venous thrombosis, surgery, cancer, disseminated intravascular coagulation, infection and tissue necrosis may lead to elevated concentration of D-Dimer. Increased concentration of D-Dimer may also be observed in the elderly or hospitalized patients with abnormal coagulation caused by bacteremia

The D-Dimer CLIA Test is intended to detect D-Dimer in human plasma or whole blood.

  • Individual ready-to-use cartridges
  • Combines the sandwich immunoassay technique with enzyme-catalyzed chemiluminescence detection
  • Sample volume: 75 μL

Range

Working range: 0.045-10 mcg/mL

Detection Limits

Limit of Blank (LOB): 0.045 mcg/mL

Precision

Intra-lot Precision

CV less than 8%

Inter-lot Precision

CV less than 10%

Linearity

Linearity between 0.045-10 mcg/mL

Interference

No significant interference was detected up to the concentrations mentioned below:

SubstanceConcentration
Hemoglobin≤ 500 mg/dL
Bilirubin≤ 20 mg/dL
Triglyceride≤ 3000 mg/dL
Total Protein≤ 5 g/dL
Rheumatoid Factor≤ 1500 IU/mL

HAMA Interference

Patient specimens containing human anti-mouse antibodies (HAMA) may give falsely elevated or decreased values. Although HAMA-neutralizing agents are added, extremely high HAMA serum concentrations may occasionally affect the results.

Hook effect

There is no high-dose hook effect at D-Dimer concentration up to 500 mcg/mL.

Reagents and Materials Provided:

  1. 19-well D-Dimer reagent cartridge
    1. Sample well (1st well)
    2. Reading well for chemiluminescent signal (19th well)
    3. Foil-sealed wells (2nd to 18th wells) comprised of a barcode indicating reagent assay information, the reagent lot number and the expiration date
  2. 3 Calibrators lyophilized powder containing D-Dimer protein at:
    1. 0 mcg/mL
    2. 5 mcg/mL
    3. 5 mcg/mL
  3. Registration card
  4. Calibrator card
  5. Instructions for Use

Materials may be required and not provided:

  1. Commercial controls

Materials required but not provided:

  1. Pipette with disposable tip to dispense up to 100 μL
  2. For other specific materials and disposables, refer to CLIAlyzer user manual
  3. CLIAlyzer instrument
  4. Powderless gloves
CATALOG #PRODUCTQUANTITYSPECIMEN
L3010 D-Dimer CLIA Test36/kitP/WB
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FOR EXPORT ONLY