Horiba Micros ES 60 Blood Cell Analyzer in Blood Donor Eligibility: A Validation Study

Area of Science:

• Hematology
• Transfusion Medicine
• Clinical Diagnostics

Background:

• Blood donation eligibility requires specific hemoglobin and platelet count thresholds.
• Accurate, precise, and user-friendly screening methods are crucial for pre-donation testing.
• Current screening methods necessitate performance evaluation for new devices.

Purpose of the Study:

• To evaluate the performance, precision, and repeatability of the Horiba Micros ES 60 hematology analyzer.
• To compare the Horiba Micros ES 60 against the Beckman Coulter DXH 800 for pre-donation screening applications.

Main Methods:

• Multi-site comparative study involving 11 Horiba devices across 6 transfusion service locations.
• Performance assessed using coefficient of variation (CV) for precision, ρ-Pearson’s correlation for concordance, and F-tests for accuracy.
• Intra-assay agreement and repeatability evaluated using CV and Kruskal−Wallis tests.

Main Results:

• Horiba Micros ES 60 demonstrated acceptable precision and strong correlation (ρ-Pearson's coefficients) with the comparator.
• Bland−Altman analysis indicated most differences fell within acceptable agreement limits.
• CV values were below reference thresholds for all tested parameters; non-significant statistical differences were found, except for platelet count.

Conclusions:

• The Horiba Micros ES 60 is deemed adequate for routine pre-donation screening.
• The device exhibits high accuracy and precision, supporting its reliability in clinical settings.
• Intra-assay agreement further validates the diagnostic accuracy of the Horiba Micros ES 60.