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HORIBA Medical Announces Independent Study Validates the Yumizen G DDi 2 Assay for Rapid D-dimer Quantification

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HORIBA Medical announces that its novel hemostatic 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]. They demonstrated it to detect venous thromboembolism (VTE) with excellent accuracy, reliability and turnaround time on HORIBA Medical’s Yumizen G800 fully automated hemostasis analyzer.

D-dimer measurement is one of the most commonly requested tests in the hemostasis laboratory and is frequently used to exclude VTE. While a number of different immunoturbidimetric 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 hemostasis analyzer range, versus other available immunoturbidimetric D-dimer assays. The evaluation results are now published in Research and Practice in Thrombosis and Haemostasis [1] and will also be presented at the forthcoming ISTH Congress 2022.

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 hemolysis, 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 hemolysis was found for hemoglobin 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 hemostasis 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 immunoturbidimetric channels of these Yumizen G hemostasis instruments, HORIBA Medical’s reagent kit delivers D-dimer results consistency and analytical performance reliability as demonstrated by the recent evaluation study [1].

The lead author of the study, Dr. Laurie Talon, will also present these data at the ISTH 2022 Congress, London, July 9-13. The link below provides more details:

https://horiba.link/ISTH2022_sympo_pdf

For further information on HORIBA Medical’s comprehensive range of hemostasis reagents and systems, please visit:

https://www.horiba.com/int/medical/products/hemostasis/

References

  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. https://doi.org/10.1002/rth2.12660
  2. Guo, Q., et al. (2018). Rheumatoid arthritis: pathological mechanisms and modern pharmacologic therapies. Bone research, 6,15. https://doi.org/10.1038/s41413-018-0016-9

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