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