Observer and biological variation of a rapid whole blood D-dimer test

Thromb Haemost. 1998 Jan;79(1):91-3.


In consecutive patients with suspected venous thromboembolism the interobserver variability of the SimpliRED D-dimer test was evaluated by two observers who independently scored one plate, the between assay variation was performed simultaneously by a third independent observer, who assessed a second plate. The biological variation was studied, 1-4 hours later by an independent evaluation. A total of 155 patients entered the study, venous thromboembolism was present in 42 patients (28%). The interobserver variability was 2/83 samples, with a kappa of 0.95 (95% confidence interval 0.88-1.0). The between assay variation was 2/98, with a kappa value of 0.96 (95% confidence interval 0.90-1.0). When testing the biological variation the observers disagreed in 2 of 69 patients (3%). The SimpliRED D-dimer assay has a good to excellent interobserver variability, between assay variation and reproducibility.

Publication types

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

MeSH terms

  • Adolescent
  • Adult
  • Confidence Intervals
  • Female
  • Fibrin Fibrinogen Degradation Products / analysis*
  • Humans
  • Male
  • Observer Variation*
  • Predictive Value of Tests
  • Prevalence
  • Reproducibility of Results
  • Thromboembolism / blood*
  • Thromboembolism / diagnosis
  • Thromboembolism / epidemiology
  • Time Factors


  • Fibrin Fibrinogen Degradation Products
  • fibrin fragment D