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. 2022 Feb 6;6(1):e12660.
doi: 10.1002/rth2.12660. eCollection 2022 Jan.

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

Laurie Talon  1 , Virginie Fourneyron  1 , Alexandre Trapani  1 , Bruno Pereira  2 , Thomas Sinegre  1 , Aurélien Lebreton  1   3
Affiliations

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

Laurie Talon et al. Res Pract Thromb Haemost. .

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.

Keywords: bilirubin; hemolysis; hemostasis; immunoturbidimetry; thrombosis; venous thromboembolism.

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Figures

FIGURE 1
FIGURE 1
Estimation of the LoQ at 10% CV; the figure shows the nonlinear relationship calculated between the error of measurement (CV%, y axis) and the D‐dimer concentration (ng/mL FEU, x axis). CV, coefficient of variation; LoQ, smallest value with an acceptable level of confidence and known uncertainty
FIGURE 2
FIGURE 2
Linearity of the Yumizen G DDi 2 assay on the Yumizen G800 analyzer
FIGURE 3
FIGURE 3
Bias (%) in D‐dimer measurement in function of hemoglobin (A), bilirubin (B) and lipid (C) levels. Dotted lines represent the limit of acceptable bias. Each color corresponds to a plasma sample, and the different points correspond to the different concentrations of hemoglobin, bilirubin, and intralipid spiked in the samples. The D‐dimer concentrations of the different samples are indicated on the right side. FEU, fibrinogen‐equivalent units
FIGURE 4
FIGURE 4
Effect of HAMAs (A) and RF (B) at different plasma D‐dimer concentrations. HAMAs, heterophilic human antimouse antibodies; ns, not significant; RF, rheumatoid factor
FIGURE 5
FIGURE 5
Bland‐Altman plots of all the D‐dimer values obtained with the Yumizen G DDi 2 assay/Yumizen G800 analyzer and: (A) Vidas D‐dimer Exclusion II/Vidas, (C) STA Liatest Ddi plus/STA‐R Max, (E) Innovance D‐dimer/CS 2100i, (G) HemosIL D‐dimer/ACL TOP 700. The x axis represents the mean of the measurements, and the y axis represents the difference between the measurements obtained with the two systems. Continuous and dotted lines represent the bias and the lower and upper limits of agreement with the 95% confidence intervals, respectively. Passing‐Bablok regression analysis are shown as B, D, F, H, respectively
FIGURE 6
FIGURE 6
Bland‐Altman plots of the D‐dimer values <1000 ng/mL FEU obtained with the Yumizen G DDi 2 assay/Yumizen G800 analyzer and (A) Vidas D‐dimer Exclusion II/Vidas, (C) STA Liatest DDi plus/STA‐R Max, (E) Innovance D‐dimer /CS 2100i, (G) HemosIL D‐dimer/ACL TOP 700. Values >1000 ng/mL FEU were excluded from the Bland‐Altman plots to improve data visualization. The x axis represents the mean of the measurements, and the y axis represents the difference between the measurements obtained with the two systems. Continuous and dotted lines represent the bias and the lower and upper limits of agreement with the 95% confidence intervals, respectively. Passing‐Bablok regression analysis are shown as B, D, F, H, respectively
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