D-dimer

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

The D-dimer assay on the Stratus^® CS Acute Care™ System™ Diagnostic System 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—in as little as 14 minutes (with on-board centrifugation).
Single‐use TestPak™ cartridges significantly reduce contamination and open‐stability issues, reducing reagent waste.
A negative D‐dimer test in conjunction with a low pretest probability score can exclude PE and may reduce unnecessary diagnostic imaging.

Stratus® D-dimer Assay

Features & Benefits

Rapid turnaround time—in as little as 14 minutes (with onboard centrifugation)
Single and ready-to-use TestPak™ cartridges
- No reconstitution
- No warming to room temperature
Heparinized 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 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 policies^2,3 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:

A negative quantitative D‐dimer assay
A negative whole‐blood‐cell qualitative D‐dimer assay in conjunction with the Wells Pretest Probability Scoring System

Technical Specifications

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