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Peer-reviewedCC BYDiagnostics (Basel, Switzerland)

Method Comparison of Three Automated D-Dimer Assays.

  • Bağnu Dündar1
  • Betül Özbek Kurtul1
  • Beyzanur Badilli2
  • Sevgi Koçyiğit Sevinç3
  • Elif Ertaş4
  • Asiye Gök Yurttaş1
4 affiliations
  1. 1Department of Medical Biochemistry, Faculty of Medicine, Atlas University, 34408 Istanbul, Türkiye.
  2. 2Department of Chemistry, Yildiz Technical University, 34220 Istanbul, Türkiye.
  3. 3Department of Biophysics, Faculty of Medicine, Kütahya Health Sciences University, 43100 Kütahya, Türkiye.
  4. 4Department of Biostatistics and Medical Informatics, Faculty of Medicine, Istanbul Atlas University, 34408 Istanbul, Türkiye.
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Abstract

Background and Objective: D-dimer results differ across analytical platforms, which may affect their clinical interpretation. This study aimed to compare the analytical agreement and threshold-based classification of three routinely used D-dimer analyzers. Methods: Of 150 consecutive residual citrated plasma specimens, 81 patient specimens with valid results on the Sysmex CS-2500, Tokra Novae MTI, and VIDAS 3 analyzers were included. Agreement was assessed using the intraclass correlation coefficient, Passing-Bablok regression, Bland-Altman analysis, and classification concordance at the fixed (500 ng/mL FEU) and age-adjusted thresholds. VIDAS 3 served solely as the comparator method. Results: Overall agreement was moderate to good; however, the platforms were not fully interchangeable. Sysmex CS-2500 and VIDAS 3 showed the closest agreement, with no significant constant or proportional bias, whereas Tokra Novae MTI exhibited significant proportional bias. Mixed classification across the three analyzers occurred in 21/81 patients (25.9%) at the fixed threshold and in 18/81 patients (22.2%) at the age-adjusted thresholds. Conclusions: Clinically relevant inter-platform differences persisted despite acceptable average agreement. Therefore, D-dimer results should not be regarded as interchangeable across analyzers, particularly near clinical decision thresholds, and platform-specific verification remains essential.

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Cite

BibTeXRIS
BibTeX
@article{dundar2026method,
  title = {{Method Comparison of Three Automated D-Dimer Assays.}},
  author = {Bağnu Dündar and Betül Özbek Kurtul and Beyzanur Badilli and Sevgi Koçyiğit Sevinç and Elif Ertaş and Asiye Gök Yurttaş},
  journal = {Diagnostics (Basel, Switzerland)},
  year = {2026},
  month = sep,
  doi = {10.3390/diagnostics16193119},
  url = {https://europepmc.org/article/MED/42882274},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Method Comparison of Three Automated D-Dimer Assays.
AU  - Bağnu Dündar
AU  - Betül Özbek Kurtul
AU  - Beyzanur Badilli
AU  - Sevgi Koçyiğit Sevinç
AU  - Elif Ertaş
AU  - Asiye Gök Yurttaş
PY  - 2026
DA  - 2026/09/25
JO  - Diagnostics (Basel, Switzerland)
DO  - 10.3390/diagnostics16193119
UR  - https://europepmc.org/article/MED/42882274
AB  - Background and Objective: D-dimer results differ across analytical platforms, which may affect their clinical interpretation. This study aimed to compare the analytical agreement and threshold-based classification of three routinely used D-dimer analyzers. Methods: Of 150 consecutive residual citrated plasma specimens, 81 patient specimens with valid results on the Sysmex CS-2500, Tokra Novae MTI, and VIDAS 3 analyzers were included. Agreement was assessed using the intraclass correlation coefficient, Passing-Bablok regression, Bland-Altman analysis, and classification concordance at the fixed (500 ng/mL FEU) and age-adjusted thresholds. VIDAS 3 served solely as the comparator method. Results: Overall agreement was moderate to good; however, the platforms were not fully interchangeable. Sysmex CS-2500 and VIDAS 3 showed the closest agreement, with no significant constant or proportional bias, whereas Tokra Novae MTI exhibited significant proportional bias. Mixed classification across the three analyzers occurred in 21/81 patients (25.9%) at the fixed threshold and in 18/81 patients (22.2%) at the age-adjusted thresholds. Conclusions: Clinically relevant inter-platform differences persisted despite acceptable average agreement. Therefore, D-dimer results should not be regarded as interchangeable across analyzers, particularly near clinical decision thresholds, and platform-specific verification remains essential.
SN  - 2075-4418
ER  -