Diagnostic accuracy of four different D-dimer assays: A post-hoc analysis of the YEARS study

Thromb Res. 2021 May;201:18-22. doi: 10.1016/j.thromres.2021.02.003. Epub 2021 Feb 6.


Introduction: For exclusion of pulmonary embolism (PE) clinical decision rules in combination with a D-dimer assay are applied. Currently available D-dimer assays are not standardized and it is unknown whether these differences have an impact on diagnostic management of suspected PE. Therefore, the aim is to explore differences between D-dimer assays and their impact on diagnostic outcome.

Methods: Data from all patients included in the YEARS study were collected. The YEARS study is a prospective, multicentre, cohort outcome study evaluating 3462 patients with suspected PE in which four different D-dimer assays were applied (Liatest, Innovance, Tinaquant, Vidas). Median D-dimer concentrations were calculated for each D-dimer assay. Sensitivity, specificity, PPV and NPV for detection of PE of all four assays were determined in patients without YEARS items and in those with ≥1 YEARS items (i.e. symptomatic deep vein thrombosis, haemoptysis, and whether PE is the most likely diagnosis).

Results: A total of 1323, 1100, 768 and 271 D-dimer concentrations were collected using the Liatest Innovance, Tinaquant and Vidas assay, respectively. Median D-dimer concentrations differed significantly between assays, with lowest values in the Tinaquant assay. In patients without YEARS items using a cutoff level of 1000 ng/mL, the NPV varied from 99,5 to 100%. In patients with ≥1 YEARS items using a 500 ng/mL cutoff, the NPV varied from 97,0 to 100% depending on the assay.

Conclusions: The overall high NPV for all assays demonstrates the clinical value of the D-dimer assay. However, these results confirm differences between D-dimer assays, which have an impact on follow-up imaging. This emphasizes the need for standardization of D-dimer assays.

Keywords: D-dimer test; Deep vein thrombosis; Diagnostic accuracy; Laboratory test; Predictive value.

MeSH terms

  • Fibrin Fibrinogen Degradation Products
  • Humans
  • Predictive Value of Tests
  • Prospective Studies
  • Pulmonary Embolism* / diagnosis
  • Sensitivity and Specificity
  • Venous Thrombosis*


  • Fibrin Fibrinogen Degradation Products
  • fibrin fragment D