End-user verification of the Maccura F810 hematology analyzer: A comparison with Mindray BC-6200

INTRODUCTION: Analytical performance verification is essential before implementing hematology analyzers in routine clin-ical practice. This study aimed to evaluate the performance characteristics of the Maccura F810 hematology analyzer.
METHODS: This study was conducted at the Medical Biochemistry Laboratory of Çanakkale Onsekiz Mart University Hospital between January and April 2023. Analytical performance was verified by evaluating precision (within-run and between-batch), carry-over, and linearity in accordance with the Clinical and Laboratory Standards Institute and the International Council for Standardization in Hematology guidelines. Additionally, 356 K2-EDTA samples from patients were used for comparative analysis with the Mindray BC-6200, including Passing-Bablok regression, Bland-Altman anal-ysis, and bias estimation at medical decision points. We compared the results with the manufacturer's claimed per-formance specifications and further evaluated them using state-of-the-art (SOTA) and minimum biological variation (MBV) performance criteria.
RESULTS: All precision results met the manufacturer's performance specifications, whereas only monocyte, eosinophil, and basophil counts exceeded the SOTA precision limits at certain concentration levels. Carry-over was negligible for white blood cell count, red blood cell count, hemoglobin, and platelet count. Linearity was confirmed across the con-centration ranges specified by the manufacturer. Bland-Altman analysis showed agreement with the manufacturer's specifications and SOTA criteria for all parameters, while all parameters except monocyte count also fulfilled the MBV criteria. Predicted bias at predefined medical decision points was within the MBV and SOTA limits for all evaluated pa-rameters, except for platelet count at 50 ×10⁹/L, where the predicted bias was 8.00% (95% CI, 3.21%-12.89%), exceeding both the MBV (7.5%) and SOTA (6.4%) limits.
DISCUSSION AND CONCLUSION: Overall, the Maccura F810 demonstrated satisfactory analytical performance and is suitable for routine clinical laboratory use, despite higher CVs observed for a limited number of parameters and a predicted PLT bias at 50 ×10⁹/L that exceeded both acceptance criteria.

Keywords: Complete blood count, hematology, instrumental analysis, method verification, performance evaluation