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Novel Hemostatic Immunoassay Detects VTE with Excellent Accuracy, Reliability and Turnaround Time

By LabMedica International staff writers
Posted on 10 May 2022
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Image: Yumizen G DDi 2 was independently validated for rapid quantification of D-dimer (Photo courtesy of Horiba Medical)
Image: Yumizen G DDi 2 was independently validated for rapid quantification of D-dimer (Photo courtesy of Horiba Medical)

D-dimer measurement is one of the most commonly requested tests in the hemostasis laboratory and is frequently used to exclude venous thromboembolism (VTE). While a number of different immunoturbidimetric assays for D-dimer are marketed for routine practice, their reliability and analytical performance can vary. Now, scientists have successfully evaluated the analytical performance of a novel hemostatic immunoassay and demonstrated it to detect VTE with excellent accuracy, reliability and turnaround time.

The independent study compared the performance of Horiba Medical’s (Kyoto, Japan) Yumizen G DDi 2 assay, designed for its Yumizen G hemostasis analyzer range, versus other available immunoturbidimetric D-dimer assays. 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 (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, the safety of the Yumizen G DDi 2 assay was strengthened further.

HORIBA’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’s reagent kit delivers D-dimer results consistency and analytical performance reliability as demonstrated by the recent evaluation study.

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