D-dimer

The D-dimer assay on the Stratus® CS Analyzer is an in vitro diagnostic test for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma. The Stratus CS D-dimer assay is intended for use in conjunction with a non-high clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) disease and as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)].

Elevated Concentrations of D-dimer are indicative of the presence of a clot and have been reported in deep vein thrombosis,1 pulmonary embolism,2,3 disseminated intravascular coagulation (DIC),4 acute aortic dissection, myocardial infarction, malignant diseases, obstetrical complications, third trimester of pregnancy, surgery or polytrauma.5

 

When minutes matter, the Stratus CS System delivers a fast, precise and accurate D-dimer result in as little as 14 minutes. The assay has a high negative predictive value (NPV).


Clinical Significance:
When patients present with chest pain, it must quickly be determined if the cause is cardiac related, a pulmonary embolism (PE), or another condition. PE is a common and potentially lethal condition; the rapid assessment and treatment of a PE can result in a dramatic reduction of morbidity and mortality. 

 

Delivering What Matters:

  • Rapid turnaround time - in as little as 14 min. (with on-board centrifugation)
  • Single and ready to use TestPak Cartridges

      - No reconstitution

      - No warming to room temperature

  • Heparinized or citrated whole blood samples

      - D-dimer and cardiac markers – one sample, one run, one instrument

  • Substantial savings potential

      - Single use TestPak Cartridges significantly reduce contamination and
        open stability issues, reducing reagent waste

      - Electronic QC (System Check) satisfies daily routine QC requirements
        permitting liquid QC flexibility

      - A negative D-dimer test in conjunction with a low pre-test probability
        score can exclude PE and may reduce unnecessary diagnostic imaging
        procedures

 

For additional information on D-dimer visit our educational website at

1 Bongard O, et al. D-dimer plasma measurement in patients undergoing major hip surgery: use in the predictionand diagnosis of postoperative proximal vein thrombosis. Thromb. Res. 1994; 74:487.

2 Bounameaux H, et al. D-dimer testing in suspected venous thromboembolism: an update. Q J Med 1997; 90:437.

3 van Beek EJR, et al. A comparative analysis of D-dimer assays in patients with clinically suspected pulmonary embolism. Thromb. Haemost. 1993; 70:408.

4 Bovill EG. Disseminated intravascular coagulation: pathophysiology and laboratory diagnosis. Fibrinolysis 1993;7:17.

5 Wells PS. The role of qualitative D-Dimer assays, clinical probability, and non invasive imaging tests for thediagnosis of deep vein thrombosis and pulmonary embolism. Semin Vasc Med 2005; 5: 340-50.

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