Limitations of D-dimer testing in unselected inpatients with suspected venous thromboembolism

Am J Med. 2003 Mar;114(4):276-82. doi: 10.1016/s0002-9343(02)01520-6.


Purpose: To determine the utility and limitations of D-dimer testing for the evaluation of venous thromboembolism in hospitalized patients.

Methods: We performed D-dimer testing by four different methods in unselected inpatients undergoing radiologic evaluation for possible venous thromboembolism. We included patients with a history of malignancy, recent surgery, thrombosis, and anticoagulation treatment. C-reactive protein levels were assayed as a measure of inflammation.

Results: Of 45 patients with radiographically proven proximal deep venous thrombosis or pulmonary embolism, 43 had elevated D-dimer levels by enzyme-linked immunosorbent assay (ELISA) (sensitivity, 96%); the specificity of the test was 23% (36/157). The qualitative non-ELISA tests had higher specificities, but their sensitivities were <70%. Nineteen patients (42%) with thrombosis had false-negative D-dimer tests by at least one assay. The specificity of the tests decreased with increasing duration of hospitalization, increasing age, and increasing C-reactive protein levels. D-dimer testing had little or no utility in distinguishing patients with thrombosis from those without in patients who had been hospitalized for more than 3 days, were older than 60 years, or had C-reactive protein levels in the highest quartile.

Conclusion: In unselected inpatients, D-dimer testing has limited clinical utility because of its poor specificity. This is particularly true for older patients, those who have undergone prolonged hospitalization, and those with markedly elevated C-reactive protein levels. In some patient subsets, a negative non-ELISA D-dimer test cannot discriminate between inpatients with and without thrombosis.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Age Factors
  • Aged
  • Agglutination Tests
  • Biomarkers / analysis
  • Case-Control Studies
  • Chi-Square Distribution
  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Fibrin Fibrinogen Degradation Products / analysis
  • Fibrin Fibrinogen Degradation Products / metabolism*
  • Humans
  • Inpatients
  • Latex Fixation Tests
  • Male
  • Middle Aged
  • Prognosis
  • Prospective Studies
  • Pulmonary Embolism / blood*
  • Pulmonary Embolism / diagnostic imaging
  • Pulmonary Embolism / therapy
  • ROC Curve
  • Radiography
  • Risk Assessment
  • Sensitivity and Specificity
  • Statistics, Nonparametric
  • Venous Thrombosis / blood*
  • Venous Thrombosis / diagnostic imaging
  • Venous Thrombosis / therapy


  • Biomarkers
  • Fibrin Fibrinogen Degradation Products
  • fibrin fragment D