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[Harmonization of cut-off values of commercially available D-dimer tests]

Beáta Török-Nagy1, Zoltán Vajda1,2, Barna Vásárhelyi1

  • 1Laboratóriumi Medicina Intézet, Semmelweis Egyetem, Általános Orvostudományi Kar Budapest, Nagyvárad tér 4., 1089.

Orvosi Hetilap
|April 9, 2019
PubMed

Insights

Optimizing D-dimer test cut-off values is crucial for accurate venous thromboembolism diagnosis. Harmonizing sensitivity and specificity across different D-dimer assays improves clinical utility.

Area of Science:

  • Clinical Chemistry
  • Hematology
  • Diagnostic Medicine

Background:

  • D-dimer tests are vital for excluding venous thromboembolic disorders.
  • Significant variations exist between D-dimer assays, complicating result interpretation.
  • Standardization of D-dimer testing is needed for reliable clinical application.

Purpose of the Study:

  • To compare three D-dimer tests: INNOVANCE D-Dimer, STA-Liatest D-Di, and Dia-D-Dimer.
  • To analyze the correlation between these D-dimer assays.
  • To harmonize sensitivity and specificity by optimizing cut-off values.

Main Methods:

  • 158 plasma samples from patients suspected of venous thromboembolism were analyzed.
  • INNOVANCE D-Dimer served as the reference assay.
  • Cut-off values for STA-Liatest D-Di and Dia-D-Dimer were adjusted between 0.2-1 µg/ml (FEU).
  • Diagnostic parameters and regression analysis were used to estimate optimal cut-off values and correlations.

Main Results:

  • STA-Liatest D-Di showed no significant difference from the reference assay with cut-offs of 0.3-1 µg/ml (FEU).
  • Dia-D-Dimer demonstrated significant differences at 0.2-0.3 µg/ml (FEU), with 0.4 µg/ml (FEU) being borderline.
  • Optimal cut-off values were determined as 0.5-0.6 µg/ml (FEU) for STA-Liatest D-Di and 0.7 µg/ml (FEU) for Dia-D-Dimer.
  • Sensitivities ranged from 82.7-100% and specificities from 35.2-96.3% across tests and cut-offs.

Conclusions:

  • Laboratories should establish optimal D-dimer cut-off values based on their specific patient populations.
  • Harmonization of D-dimer assays can improve diagnostic accuracy for venous thromboembolism.
  • Further research may be needed to validate these optimized cut-off values in diverse clinical settings.
Abstract

Keywords:
D-dimercut-off valueharmonizationharmonizációvágóérték

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