Evaluation of a quantitative D-Dimer latex immunoassay for acute pulmonary embolism diagnosed by computed tomographic angiography

David A. Froehling, Paul R. Daniels, Stephen J. Swensen, John A. Heit, Jayawant N. Mandrekar, Jay H. Ryu, Peter L. Elkin

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12 Scopus citations


OBJECTIVE: To determine the sensitivity and specificity of a quantitative plasma fibrin D-dimer latex immunoassay (LIA) for the diagnosis of acuta pulmonary embolism. SUBJECTS AND METHODS: Study subjects were Mayo Clinic Rochester inpatients and outpatients with suspected acute pulmonary embolism; all had undergone quantitative D-dimer LIA testing and multidetector-row computed tomographic (CT) angiography between August 3, 2001, and November 10, 2003. Multidetector-row CT angiography was the diagnostic reference standard. RESULTS: Of 1355 CT studies, 203 (15%) were positive for acute pulmonary embolism. Median B-dimer levels were significantly higher for patients with acute pulmonary embolism (1425 ng/ml) than for patients without (500 ng/mL) (P<.001). Tlte highest specificity that optimizes sensitivity for acute pulmonary embolism was achieved by using a discriminant value of 300 ng/mL, which yielded a sensitivity of 0.94 (95% confidence interval [CI], 0.89-0.97), a specificity of 0.27 (95% CI, 0.25-0.30), and a negative predictive value of 0.96 (95% CI, 0.93-0.98). CONCLUSION: The quantitative D-dimer LIA with a discriminant value of 300 ng/mL had high sensitivity and high negative predictive value but low specificity for the diagnosis of acute pulmonary embolism. On the basis of these results, we believe that a negative quantitative D-dimer LIA result and a low pretest probability of thromboembolism together are sufficient to exclude acute pulmonary embolism.

Original languageEnglish (US)
Pages (from-to)556-560
Number of pages5
JournalMayo Clinic proceedings
Issue number5
StatePublished - May 2007

ASJC Scopus subject areas

  • General Medicine


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