Abstract
IntroductionFor 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. MethodsData 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). ResultsA 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. ConclusionsThe 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.
Highlights
For exclusion of pulmonary embolism (PE) clinical decision rules in combination with a D-dimer assay are applied
In the widely used Wells algorithm, the D-dimer concentration is only measured to Abbreviations: CTPA, computer tomography pulmonary angiography; DVT, deep vein thrombosis; IQR, interquartile range; NA, not applicable; NPV, negative predictive value; PE, pulmonary embolism; PPV, positive predictive value; SD, standard deviation; WHO, World Health Organization
Of the 3462 patients in the YEARS study D-dimer concentrations were analyzed with the Liatest, Innovance, Tinaquant and Vidas assay in 1323, 1100, 768 and 271 pa tients, respectively
Summary
For exclusion of pulmonary embolism (PE) clinical decision rules in combination with a D-dimer assay are applied. Conclusions: The overall high NPV for all assays demonstrates the clinical value of the D-dimer assay These results confirm differences between D-dimer assays, which have an impact on follow-up imaging. Several publi cations have reported a significant degree of variability in test results between different assays [2,3] This is evident when reviewing the results of external quality control programs such as the program pro vided by the ECAT Foundation that includes approximately 650 participating laboratories worldwide (Fig. 1). It has not been demonstrated whether standardization would benefit patients. In the widely used Wells algorithm, the D-dimer concentration is only measured to Abbreviations: CTPA, computer tomography pulmonary angiography; DVT, deep vein thrombosis; IQR, interquartile range; NA, not applicable; NPV, negative predictive value; PE, pulmonary embolism; PPV, positive predictive value; SD, standard deviation; WHO, World Health Organization
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