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Clinical Chemistry 49: 1483-1490, 2003; 10.1373/49.9.1483
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(Clinical Chemistry. 2003;49:1483-1490.)
© 2003 American Association for Clinical Chemistry, Inc.

Hemostasis and Thrombosis

Comparison of Diagnostic Accuracies in Outpatients and Hospitalized Patients of D-Dimer Testing for the Evaluation of Suspected Pulmonary Embolism

John E. Schrecengost1, Robin D. LeGallo1, James C. Boyd1,a, Karel G.M. Moons4, Steven L. Gonias1,2, C. Edward Rose, Jr3 and David E. Bruns1

Departments of
1 Pathology,
2 Biochemistry and Molecular Biology, and
3 Internal Medicine, University of Virginia Health System, Charlottesville, VA 22908.
4 Julius Center for Health Sciences and Primary Care, University Medical Center, 3508TA Utrecht, The Netherlands.

aAddress correspondence to this author at: Department of Pathology, PO Box 800214, University of Virginia Medical School, Charlottesville, VA 22908. Fax 434-243-5930; e-mail jboyd{at}virginia.edu.

Background: The ability of various D-dimer assays to exclude the diagnosis of thromboembolic diseases is controversial. We examined the diagnostic accuracy of two D-dimer methods in hospitalized patients and outpatients.

Methods: We studied consecutive patients for whom D-dimer testing was ordered for investigation of suspected pulmonary embolism. We measured D-dimer by an ELISA (VIDAS D-dimer) and an enhanced microlatex immunoassay method (Diagnostica Stago STA Liatest D-di). Patient diagnoses were based on imaging studies or, when these were not performed, on follow-up by review of medical records 3 months later.

Results: We examined 233 hospitalized patients and 234 outpatients with a mean age of 58 years (range, 1–92 years) and a female-to-male ratio of 1.4 to 1. Thromboembolism was present in 8% of outpatients and 12% of hospitalized patients. In outpatients, the negative predictive values were 98% [95% confidence interval (CI), 93–100%] and 99% (94–100%) for the microlatex and ELISA methods, respectively, at the recommended cutoffs. Areas under the ROC curves were similar for the two methods [0.77 (95% CI, 0.67–0.87) and 0.81 (0.73–0.89), respectively]. By contrast, in hospitalized patients, the confidence intervals for the areas under the ROC curves included 0.5 [0.60 (95% CI, 0.50–0.71) and 0.56 (0.44–0.67)].

Conclusions: For hospitalized patients, in contrast to outpatients, the diagnostic accuracy of D-dimer testing for pulmonary embolism is poor in a tertiary care setting, presumably reflecting thrombosis and comorbidities, other than pulmonary embolism, that increase the D-dimer concentrations in these patients. The patient population studied appears more important than assay method in studies of the diagnostic accuracy of D-dimer testing.




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