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Diagnostic accuracy of four different D-dimer assays: A post-hoc analysis of the YEARS study
Henrike M Hamer1, An K Stroobants1, Roisin Bavalia2
1Department of Clinical Chemistry, Amsterdam UMC, Amsterdam, the Netherlands.
Insights
Differences in D-dimer assays impact pulmonary embolism diagnosis. Standardization is crucial for reliable diagnostic outcomes in suspected PE cases.
Area of Science:
- Medical Diagnostics
- Clinical Chemistry
- Cardiovascular Medicine
Background:
- Pulmonary embolism (PE) diagnosis often relies on clinical decision rules combined with D-dimer testing.
- Current D-dimer assays lack standardization, raising concerns about their impact on diagnostic management.
- Variability between assays may affect the accuracy and reliability of PE exclusion.
Purpose of the Study:
- To investigate the differences between four commercially available D-dimer assays.
- To assess the impact of these assay differences on the diagnostic outcome for suspected pulmonary embolism.
- To evaluate the clinical utility of D-dimer assays in the context of varying standardization.
Main Methods:
- Prospective, multicentre cohort outcome study (YEARS study) involving 3462 patients.
- Application of four distinct D-dimer assays: Liatest, Innovance, Tinaquant, and Vidas.
- Determination of sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for PE detection, stratified by YEARS criteria.
Main Results:
- Median D-dimer concentrations varied significantly across the four assays, with Tinaquant showing the lowest values.
- Negative predictive values (NPVs) remained high across all assays, ranging from 97.0% to 100% for patients with and without YEARS items.
- Assay differences were observed to influence follow-up imaging decisions.
Conclusions:
- Despite assay variations, D-dimer testing demonstrates high clinical value due to consistently high NPVs.
- Significant differences exist between D-dimer assays, impacting diagnostic management and follow-up imaging.
- Standardization of D-dimer assays is essential to ensure consistent and reliable diagnostic performance in suspected PE cases.
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.
