Exclude pulmonary embolism in as little as 14 minutes in a near-patient setting

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The D-dimer assay on the Stratus® CS 200 Acute Care™ Diagnostic 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)].



Features & Benefits

  • Rapid turnaround time—in as little as 14 minutes (with onboard centrifugation)
  • Single and ready-to-use TestPak™ cartridges
                o  No reconstitution
                o  No warming to room temperature
  • Heparinized whole-blood samples
                o  D-dimer and cardiac markers—one sample, one run, one instrument
  • Substantial savings potential
                o  Single-use TestPak™ cartridges significantly reduce contamination and
                    open stability issues, reducing reagent waste.
                o  Electronic QC (System Check) satisfies daily routine QC requirements,
                    permitting liquid QC flexibility.
                o  A negative D-dimer test in conjunction with a low pretest probability score    
                    can exclude PE and may reduce unnecessary diagnostic imaging procedures. 

Clinical Use

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

Approximately 10% of diagnosed acute PE patients die within 60 minutes. PE is so common and lethal that the American Public Health Association recommends that diagnosis be sought actively in every patient who presents with any chest symptoms that cannot be proven to have another cause.1

Guidelines for Assessing Venous Thromboembolism (VTE)
The American College of Emergency Physicians issued clinical policies2,3 for evaluating patients with suspected venous thromboembolism (VTE). They recommend, in patients with a low clinical or pretest probability, a lower extremity DVT or PE can be ruled out with:

Technical Specifications

Assay Range6 – 5000 ng/mL (µg/L) FEU
Sensitivity6 ng/mL FEU
Precision (CV)4.1% at 412 ng/mL
Calibration Stability60 days
DilPak™ Automatic DilutionYes
Sodium Heparin TubesYes
Lithium Heparin TubesYes


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Related Products, Services & Resources

1. American Public Health Association. Deep vein thrombosis: advancing awareness to protect patient lives. 2003 Feb 26.
2. Plaut D, Shafer D. Advance/Laboratory. 2002;3:1‐5
3. Brown MD, et al. Annals of Emergency Medicine. 2002;40:133‐144.

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