January 1, 1995Thrombosis and Haemostasis
Application of a Novel and Rapid Whole Blood Assay for D-Dimer in Patients with Clinically Suspected Pulmonary Embolism
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Why the study?
Does the SimpliRED D-dimer whole blood assay accurately exclude pulmonary embolism in patients with clinically suspected PE?
Population
86 consecutive patients with clinically suspected pulmonary embolism (PE)
Comparison
SimpliRED D-dimer whole blood assay vs Reference standard including…
Design
Cohort
Follow-up
3 months
Authors
Discussion
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Implication
May support bedside PE exclusion; leaves open need for prospective validation before practice change.
Key Points
- To assess the clinical utility of the SimpliRED D-dimer assay for diagnosing pulmonary embolism.
- Prospective cohort study of 86 patients with suspected pulmonary embolism.
- Patients underwent SimpliRED D-dimer assay, ventilation/perfusion lung scanning, and impedance plethysmography.
- Classification of patients into PE-positive or PE-negative based on defined criteria.
- D-dimer assay sensitivity was 94%, negative predictive value was 98%, specificity was 66%, and positive predictive value was 38%.
- In patients without comorbid conditions, specificity rose to 98% and positive predictive value to 83%.
- Wide 95% confidence interval for positive predictive value in the subgroup with only six abnormal D-dimer levels.
Structured PICO
Does the SimpliRED D-dimer whole blood assay accurately exclude pulmonary embolism in patients with clinically suspected PE?
P
Population
86 consecutive patients with clinically suspected pulmonary embolism (PE)
I
Intervention
SimpliRED D-dimer whole blood assay
C
Comparator
Reference standard including ventilation/perfusion (V/Q) lung scanning, bilateral impedance plethysmography (IPG), and/or pulmonary angiography
O
Outcome
Diagnostic accuracy (sensitivity, specificity, positive predictive value, and negative predictive value) of the D-dimer assay for pulmonary embolismsurrogate
The rapid whole blood D-dimer assay demonstrates high sensitivity and negative predictive value, suggesting utility as a bedside exclusionary test for suspected pulmonary embolism.
Limitations
- Small number of patients with abnormal D-dimer level in the subgroup without comorbid conditions, leading to wide confidence intervals
- Requires evaluation in large clinical management studies
Cite This Study
Ginsberg et al. (1995) studied this question.
Topics
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