Predictive Value of a Rapid Immunometric NycoCard D-dimer Assay for Acute Pulmonary Embolism
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Abstract
Background: The reported diagnostic performance of D-dimer assay for excluding pulmonary embolism (PE) vary widely. This study was carried out to assess the diagnostic performance of NycoCard D-dimer assay in suspected PE patients. Objective: To determine if a D-dimer assay can reliably exclude PE in patients with suspected PE. Methods: The patients evaluated for PE with a CT pulmonary angiography (CTPA) and D-dimer assay were eligible for inclusion. The electronic medical records of the patients were reviewed to analyze the diagnostic performance of NycoCard D-dimer assay for excluding acute PE. Collected data included the presence or absence of PE, D-dimer result and patient demographics. Results: A total of 229 consecutive patients underwent CTPA for acute PE and had a D-dimer measurement performed. Pulmonary embolisms were reported for 86/229 (37%) CTPAs. Overall, the D-dimer assay was found to have a sensitivity and specificity of 96.5% and 29.4%, respectively, for the diagnosis of PE, with a positive predictive value (PPV) and negative predictive value (NPV) of 45.1% and 93.3%, respectively. The negative predictive value in low or moderate clinical probability of PE is 95.5% (95% CI, 84.5% to 99.4%). The likelihood ratio associated with a negative D-dimer test result was 0.09 (CI, 0.02-0.38) Conclusions: A normal NycoCard D-dimer test result is useful in excluding PE when the clinical probability of the presence of PE is low or intermediate. An understanding of the physiological basis and limitations of D-dimer value may contribute to reduce its inappropriate use.
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