Analytical performance of a new immunoturbidimetric D-dimer assay and comparison with available assays

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Laurie Talon PharmD¹ | Virginie Fourneyron BSc¹ | Alexandre Trapani BSc¹ | Bruno Pereira PhD² | Thomas Sinegre PhD¹ | Aurélien Lebreton PhD^1,3

¹Service d’Hématologie Biologique, CHU Clermont-Ferrand, Clermont-Ferrand, France
²Biostatistics Unit, Direction de la Recherche Clinique, CHU Clermont-Ferrand, Clermont-Ferrand, France
³Unité de Nutrition Humaine, UMR 1019, INRAE-Université d’Auvergne, Clermont-Ferrand, France

Abstract

Background: The routine D-dimer quantification to exclude venous thromboembolism has led to the development of many assays, the usefulness of which depends on their reliability and performance. 

Objective: We evaluated the analytical performances of the immunoturbidimetric Yumizen G DDi 2 assay (HORIBA Medical, Montpellier, France) performed on the Yumizen G800 analyzer and compared it with other available D-dimer assays.

Methods: Within-run and between-run imprecision were evaluated using low-and high-level quality-control plasma samples. Interference due to hemolysis, icterus, lipemia, rheumatoid factor (RF), or heterophilic antibodies (human antimouse antibodies [HAMAs]) was evaluated by spiking plasma samples with hemolysate, bilirubin, Intralipid, RF, or HAMAs. The measurements obtained with the different D-dimer assays were compared using Passing-Bablok regression analysis and Bland-Altman plot method, using fresh citrated plasma samples collected from 66 consecutive routine patients with a wide range of D-dimer concentrations.

Results: Within-and between-run variation coefficients for the Yumizen G DDi 2 assay ranged from 1.7% to 5.8% and from 2.8% to 5.5%, respectively. Hemolysis and icterus did not have any effect up to 10 g/L hemoglobin and 300 mg/L bilirubin. Lipemia seemed to generate an underestimation of D-dimer concentration when the Intralipid concentration was >5 g/L. RF and HAMAs did not have any effect. The Passing-Bablok and Bland-Altman analyses showed small differences with other available D-dimer assays, which were more pronounced with increasing values. Conclusions: Its analytical performances and main technical features indicate that the new Yumizen G DDi 2 assay is suitable for the rapid quantification of D-dimer in clinical hemostasis laboratories.

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