MVelizarova Evaluation of automated hematology analyzer DYMIND DH76 compared to SYSMEX XN 1000 system

Analytical performance evaluation of DYMIND DH76

  • Milena Velizarova Medical University Sofia, Dpt of Clinical Laboratory
  • Teodora Yacheva Clinical Laboratory & Clinical Pharmacology, UMBAL Alexandrovska, Sofia, Bulgaria
  • Mariana Genova Medical University Sofia, Dpt of Clinical Laboratory
  • Dobrin Svinarov Medical University Sofia, Dpt of Clinical Laboratory
DOI: https://doi.org/10.5937/jomb0-28836
Keywords: hematology analyzer DYMIND DH76, performance evaluation

Abstract


Background: DYMIND DH76 (DYMIND BIOTECH, China) is a new automated hematology system designed to provide CBC count, including 5-part WBC differential count, and its analytical performance should be assessed before adoption for clinical use.

Methods: The analyzer was evaluated according to the International council for standardization in hematology guideline. The purposes of this study were to assess its analytical performance in comparison to SYSMEX XN 1000 hematology analyzer currently used in our laboratory, as well as a comparison between automated and manual WBC differential.

Results: Within-run precision in all concentration ranges was very good with coefficients of variation (CVs) between 0.02% and 2.5% except for platelets over 500×109/L (CV 9.5%). Within-batch imprecision showed CVs lower the declared deviation ranges. Accuracy (defined as trueness) was excellent for all CBC and white cell differential parameters, compared with the state of the art%. Linearity was confirmed with excellent regression coefficients (0.999-1.000), even in the lowest values, and carryover was ≤ 1%. Comparison between DYMIND DH76 and SYSMEX XN 1000 also was very good with correlation coefficients (R2) for WBC (1.000), RBC (0.999), hemoglobin (0.999) and PLT over 50x109/L (0.994) and R2 was lower but still acceptable (0.910) for PLT<50x109/L. R2 for neutrophils, lymphocytes, eosinophils, basophils and monocytes were 0.974, 0.982, 0.957, 0.625 and 0.836, respectively, in the comparison between manual and DYMIND DH76 automated differential WBC counts. Conclusion: With excellent analytical performance and acceptable comparative analysis, DYMIND DH76 hematology analyzer covered the predefined international standards and requirements, and is fully appropriate for clinical application.

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Published
2021/02/18
Issue
Vol. 40 No. 4 (2021): Journal of Medical Biochemistry
Section
Original paper

Copyright (c) 2021 Milena Velizarova, Teodora Yacheva, Mariana Genova, Dobrin Svinarov

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