
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)].
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:
D-dimer |
|
Assay Range |
6 – 5000 ng/mL (µg/L) FEU |
Sensitivity |
6 ng/mL FEU |
Precision (CV) |
4.1% at 412 ng/mL |
Calibration Stability |
60 days |
DilPak™ Automatic Dilution |
Yes |
Sodium Heparin Tubes |
Yes |
Lithium Heparin Tubes |
Yes |
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