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Related Experiment Videos

A latex D-dimer reliably excludes venous thromboembolism.

S M Bates1, A Grand'Maison, M Johnston

  • 1Department of Medicine, McMaster University, Hamilton, Ontario, Canada. batesm@mcmaster.ca

Archives of Internal Medicine
|February 15, 2001
PubMed
Summary

The MDA D-Dimer assay demonstrates high sensitivity for excluding venous thromboembolism (VTE). A negative D-dimer test can reliably rule out VTE in patients with low to moderate pretest probability.

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Area of Science:

  • Hematology
  • Diagnostic Medicine
  • Clinical Pathology

Background:

  • D-dimer, a fibrin degradation product, is sensitive for suspected venous thrombosis.
  • Traditional latex D-dimer assays lack sufficient sensitivity to rule out venous thromboembolism (VTE).

Purpose of the Study:

  • To evaluate the clinical utility of the MDA D-Dimer latex assay.
  • To determine if the assay can reliably exclude venous thromboembolism (VTE).

Main Methods:

  • Retrospective cohort study of 595 patients with suspected venous thromboembolism.
  • Assessed D-dimer levels and compared with objective VTE testing and 3-month follow-up.
  • Calculated sensitivity, specificity, predictive values, and negative likelihood ratios for the assay.

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Main Results:

  • The MDA D-Dimer assay showed 96% overall sensitivity and 98% negative predictive value.
  • In patients with low or moderate pretest probability, sensitivity was 97% and negative predictive value was 99%.
  • Negative likelihood ratio was 0.09, indicating strong exclusion power.

Conclusions:

  • The MDA D-Dimer assay is the first latex agglutination assay sensitive enough for clinical use in excluding VTE.
  • A negative MDA D-Dimer result can potentially serve as a standalone test to exclude VTE in low-to-moderate risk patients.