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D-Dimer Reporting and Harmonization: Analysis of College of American Pathologists D-Dimer Proficiency Testing Program
Eric Salazar1, Kristi Smock2, Taryn Cazzolli1
1Department of Pathology and Laboratory Medicine, UT Health San Antonio, San Antonio, Texas, United States.
Seminars in Thrombosis and Hemostasis
|February 6, 2026
Summary
D-dimer testing shows significant unit reporting discrepancies in proficiency testing, potentially impacting clinical accuracy. Harmonizing results revealed common deviations, highlighting the need for standardized D-dimer reporting practices.
Area of Science:
- Clinical Chemistry
- Hematology
- Laboratory Medicine
Background:
- D-dimer is vital for diagnosing thrombotic and fibrinolytic conditions.
- Challenges in D-dimer testing include assay variability and non-standardized reporting.
- The College of American Pathologists (CAP) Hemostasis and Thrombosis Committee (HaTC) investigated D-dimer reporting.
Purpose of the Study:
- To analyze D-dimer reporting practices using proficiency testing data from 2020-2023.
- To quantify the proportion of laboratories reporting potentially incorrect D-dimer units.
- To identify trends in D-dimer unit reporting across different instrument/reagent combinations.
Main Methods:
- Analysis of D-dimer proficiency testing data from multiple laboratories.
- Harmonization of all D-dimer results to ng/mL fibrinogen equivalent units (FEU).
- Assessment of distinct entry populations per instrument/reagent combination to identify reporting deviations.
Main Results:
- Laboratories frequently report D-dimer units different from assay package inserts.
- Data from identical instrument/reagent combinations clustered around different means, indicating reporting or conversion issues.
- Entries in mg/L or ug/mL DDU often showed significant deviations from the main population.
Conclusions:
- Proficiency testing reveals potential issues with D-dimer unit reporting.
- Discrepancies suggest problems with unit standardization or conversion in laboratory practices.
- Further research is needed to determine if these reporting issues affect clinical D-dimer interpretation.
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