Details

Autor(en) / Beteiligte

• Hamer, Henrike M.
• Stroobants, An K.
• Bavalia, Roisin
• Ponjee, Gabrielle A.E.
• Klok, Frederikus A.
• van der Hulle, Tom
• Huisman, Menno V.
• Hendriks, Henriët A.
• Middeldorp, Saskia

Titel

Diagnostic accuracy of four different D-dimer assays: A post-hoc analysis of the YEARS study

Ist Teil von

• Thrombosis research, 2021-05, Vol.201, p.18-22

Ort / Verlag

United States: Elsevier Ltd

Erscheinungsjahr

2021

Quelle

Elsevier ScienceDirect Journals

Beschreibungen/Notizen

• 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. 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). 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. 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. •D-dimer levels differ between assays, emphasizing the need for standardization.•Patients without YEARS items (i.e. low probability for PE) with D-dimer below 1000 ng/mL varied from 71% to 82%.•Patients with ≥1 YEARS items (i.e. increased probability for PE) with D-dimer below 500 ng/mL varied from 15% to 29%.•Differences in assays result in differences in numbers of follow-up imaging.•Despite their differences, all assays show a high NPV of >97% demonstrating their clinical value.