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The performance of quantitative D-dimer assays in laboratory routine
Michael Spannagl1, Frits Haverkate, Hans Reinauer
1INSTAND e.V., Düsseldorf, Germany. mispannagl@t-online.de
Summary
D-dimer assays show significant variability in clinical labs, hindering accurate diagnosis of venous thrombosis. Standardization is crucial for reliable D-dimer testing and patient care.
Area of Science:
- Clinical Chemistry
- Hematology
- Laboratory Medicine
Background:
- D-dimer testing is vital for excluding venous thrombosis and monitoring hypercoagulability.
- Limited data exists on D-dimer assay performance in external quality assessment schemes.
Purpose of the Study:
- To evaluate the performance and comparability of D-dimer assays across clinical laboratories.
- To assess the impact of assay variability on diagnostic cut-off values.
Main Methods:
- 423 laboratories analyzed plasma pools with varying D-dimer levels.
- A questionnaire gathered data on assay calibration, cut-off assignment, and clinical application.
- Results from 20 different D-dimer assays were analyzed.
Main Results:
- Significant inter-assay variability was observed, with results varying up to 20-fold for a single sample.
- High variability around established cut-off values complicates the exclusion of venous thrombosis and pulmonary embolism.
- Lack of standardization in calibration concepts obstructs result comparability.
Conclusions:
- Harmonization and standardization of D-dimer assays are essential for clinical routine.
- Current variability prevents the establishment of universally accepted cut-off values.
- Improved standardization will enhance the reliability of D-dimer measurements for patient diagnosis and management.