Journal List > Korean J Lab Med > v.28(6) > 1011501

Park, Seo, Yoon, Choi, Shin, Uh, and Kim: Utility of D-dimer Assay for Diagnosing Pulmonary Embolism: Single Institute Study

Abstract

Background

Pulmonary embolism (PE) presents with diverse non-specific signs and symptoms and its diagnosis mainly depends on diagnostic imaging tests which are laborious and not cost-effective, and only a small proportion of patients with suspected PE actually have the disease. The aim of this study was to analyze the utility of D-dimer test for diagnosing PE by categorizing patients into ‘PE likely’ and ‘PE unlikely’ groups using Wells score for clinical probability.

Methods

One hundred forty consecutive patients with clinically suspected PE, in whom D-dimer and imaging tests were performed were enrolled. Dignosis of PE was made when the imaging tests were positive. Wells scores were retrospectively assigned and the dignostic utility of D-dimer test was analyzed.

Results

Of the 140 patients studied, D-dimer test was positive in 97 and diagnostic imaging tests revealed PE, deep vein thrombosis (DVT), and PE+DVT in 24, 3, and 7 patients, respectively. For the diagnosis of PE, D-dimer test with cutoff value of ≥230 ng/mL showed sensitivity, specificity, and negative predictive value of 96.8%, 39.6%, and 97.7%, respectively. These values were 96.3%, 37.9%, and 91.7% in ‘PE likely’ group (n=56), and 100%, 38.8%, and 100% in ‘PE unlikely’ group (n=84). Among 43 patients with D-dimer values of <230 ng/mL, only one patient was diagnosed with PE, who belonged to the ‘PE likely’ group.

Conclusions

D-dimer test cannot be used as a stand-alone test to diagnose PE, but it can be helpful for exclusion of PE especially in ‘PE unlikely’ group according to Wells score.

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Table 1.
Wells score for pulmonary embolism
Variables Points
Clinical signs and symptoms of DVT (minimum of leg swelling and pain with palpation of the deep veins) 3.0
PE more likely than an alternative diagnosis 3.0
Heart rate >100/min 1.5
Immobilization or surgery in the previous 4 weeks 1.5
Previous DVT/PE 1.5
Hemoptysis 1.0
Malignancy (receiving treatment, treated in the last 6 months or palliative) 1.0

Source: Wells et al. [17].

>4, probability of PE is ‘likely'; ≤4, probability for PE is ‘unlikely'.

Abbreviations: DVT, deep vein thrombosis; PE, pulmonary embolism.

Table 2.
Demographic and clinical characteristics of patients
Characteristics Patients (N=140)
Age, mean (range), yr 61.7 (18-96)
Male 76 (54.3%)
Outpatients 93 (66.4%)
Previous VTE 23 (16.4%)
Chronic heart and/or respiratory disease 53 (37.9%)
Cancer 29 (20.7%)
Immobilization or recent surgery 27 (19.3%)
New or aggravating dyspnea 115 (82.1%)
Chest pain 95 (67.9%)
Heart rate >100/min 38 (27.1%)
Hemoptysis 4 (2.9%)
Clinical signs of DVT 8 (5.7%)

Abbreviations: VTE, venous thromboembolism; DVT, deep vein thrombosis.

Table 3.
Diagnostic utility of D-dimer test in PE-likely and -unlikely groups by Wells criteria
Clinical probability of PE (N=140) Sensitivity Specificity Negative predictive value ncidence of PE, N (%)
Likely (56) 26/27 11/29 11/12 27
  (96.3%) (37.9%) (91.7%) (48.2%)
Unlikely (84) 4/4 31/80 31/31 4
  (100%) (38.8%) (100%) (4.8%)

DVT only 3 included;

PE incidence, total: 31/140=22%

Abbreviations: See Table 1

Table 4.
Diagnosis and D-dimer levels
Diagnosis N D-dimer (≥230 ng/mL) D-dimer (<230 ng/mL)
DVT only 3 3 0
DVT and PE 7 7 0
PE only 24 23 1
No VTE (with imaging) 106 64 42
Total 140 97 43

Sensitivity of D-dimer for the diagnosis of PE: 30/31 (96.8%).

∗Specificity of D-dimer for the diagnosis of PE: 42/106 (39.6%).

∗Negative predictive value: 42/43 (97.7%).

Abbreviations: See Table 1, 2.

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