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HORIBA Medical’s D-dimer immunoassay displays excellent analytical performance in independent evaluation study

HORIBA Medical says that its novel haemostatic immunoassay, Yumizen G DDi 2, has been independently validated for the rapid quantification of D-dimer. Scientists from the Hematology Department, University Hospital of Clermont-Ferrand, have successfully evaluated its analytical performance [1]. Using HORIBA Medical’s Yumizen G800 fully automated haemostasis analyzer, they detected venous thromboembolism (VTE) with excellent accuracy, reliability and turnaround time.

D-dimer measurement is one of the most commonly requested tests in the haemostasis laboratory and is frequently used to exclude VTE. While a number of different immuno-turbidimetric assays for D-dimer are marketed for routine practice, their reliability and analytical performance can vary. The independent study compared the performance of HORIBA Medical’s Yumizen G DDi 2 assay, designed for its Yumizen G haemostasis analyzer range, versus other available immunoturbidimetric D-dimer assays. The evaluation results are published in Research and Practice in Thrombosis and Haemostasis [1].

The study analyzed the precision of Yumizen G DDi 2 by running repeat assays with a standardized control sample and found its coefficient of variation to fall within an ideal range for diagnostic purposes. The lower and upper detection limits of the Yumizen G DDi 2 assay were comparable to other D-dimer immunoassays tested, and notably it excelled in assay linearity, which was found to be maintained for a broad range of concentrations. The calculated linear range (up to 32700ng/mL FEU) extended significantly further than that specified by HORIBA Medical (up to 20000ng/mL FEU). This makes the Yumizen G DDi 2 assay ideal for the direct measurement of most clinical samples without need for manual dilution steps, therefore decreasing sample turnaround time.

D-dimer immunoassays can often be marred by interference from haemolysis, icterus and lipemia, or heterophilic antibodies such as HAMAs and RF, and the study evaluated the Yumizen G DDi 2 assay for each. No significant impact of haemolysis was found for haemoglobin concentrations up to 10g/L, which was greater than other D-dimer assays. In addition, no interference of HAMAs (up to 500ng/mL) and RF (up to 935UI/mL) was detected. Since RF levels rarely exceed 1000UI/mL in clinical practice [2], the safety of the Yumizen G DDi 2 assay was strengthened further.

HORIBA Medical’s Yumizen G DDi reagent kit is available for its comprehensive range of Yumizen G haemostasis instruments which covers the needs of any laboratory. The dedicated coagulation portfolio includes the fully automatic Yumizen G800, Yumizen G1500 and Yumizen G1550, as well as semi-automatic Yumizen G200 and Yumizen G400 analyzers. Using antibody-coated latex particles and measured via the immuno-turbidi-metric channels of these Yumizen G haemostasis instruments, HORIBA Medical’s reagent kit delivers D-dimer results consistency and analytical performance reliability as demonstrated by the recent evaluation study.

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1. Talon, L., et al. (2022). Analytical performance of a new immunoturbidimetric D-dimer assay and comparison with available assays. Research and Practice in Thrombosis and Haemostasis, 6(1), e12660.
2. Guo, Q., et al. (2018). Rheumatoid arthritis: pathological mechanisms and modern pharmacologic therapies. Bone research, 6,15.