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  4. Cardiac Assays
  5. D-dimer

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

The D-dimer assay on the Stratus庐 CS 200 Acute Care鈩 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)].

  • Rapid turnaround time鈥攊n as little as 14 minutes (with on-board centrifugation).
  • Single鈥恥se TestPak鈩 cartridges significantly reduce contamination and open鈥恠tability issues, reducing reagent waste.
  • A negative D鈥恉imer test in conjunction with a low pretest probability score can exclude PE and may reduce unnecessary diagnostic imaging.
D-dimer
D-dimer

Features & Benefits

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

Clinical Use

D-dimer

When patients present with chest pain, clinicians must quickly determine if the cause is cardiac鈥恟elated, 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

D-dimer

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

D-dimer

Assay Range

6 鈥 5000 ng/mL (碌g/L) FEU

Sensitivity

6 ng/mL FEU

Precision (CV)

4.1% at 412 ng/mL

Calibration Stability

60 days

DilPak鈩 Automatic Dilution

Yes

Sodium Heparin Tubes

Yes

Lithium Heparin Tubes

Yes

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鈥5
3
Brown MD, et al. Annals of Emergency Medicine. 2002;40:133鈥144.

The products/features (mentioned herein) are not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed. Please contact your local Siemens Healthineers organization for further details.