Verification and comparison of Sysmex KX-21N, Cell-Dyn 1800 and Horiba ABX Micros ES 60 automated hematology analyzers at Tikur Anbessa Specialized Hospital Addis Ababa, Ethiopia
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Date
2017-06
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Addis Ababa University
Abstract
Background: Laboratory testing plays a crucial role in the detection, diagnosis and treatment of
disease in patients. Analytical evaluation of a new analyzer or method should be done in order to
confirm the declared specifications before its introduction into the routine use. Agreement of all
automated hematology analyzers must be carried out in all laboratories. But, the practice of using
automated analyzers interchangeably without evaluation is common in our country including
Tikur Anbessa specialized hospital (TASH).
Objective: To verify performance and compare agreement of Cell-Dyn 1800, Sysmex KX-21N
and Horiba ABX micros ES 60 hematology analyzers found in TASH.
Methods: A cross sectional study was conducted to verify performance and assess agreement
between Cell-Dyn 1800, Sysmex KX-21N and Horiba ABX micros ES
60
hematology analyzers
at Tikur Anbessa specialized hospital, Addis Ababa, Ethiopia. The study period was from
February to May 2017. According to the CLSI guideline a total of 267 samples were analyzed in
duplicates on the three analyzers to verify and compare them. Data cleaning and analysis were
performed by Microsoft excel 2007 and SPSS version 20.
Result: We found that minimal carryover (< 0.5%) and excellent linearity for white blood cell,
hemoglobin, red blood cell and platelet (r > 0.999). Precision was good for all major CBC
parameters with % CV< 2.0. Agreement between most of the parameters of the analyzers lies in
the limits of agreement for more than 95% of cases according to the Bland-Altman plot analysis.
Pearson correlation and linear regression graph showed that the three analyzers were well
correlated (r > 0.900) for major CBC parameters. The correlation of WBC differential-
neutrophil and lymphocyte were excellent (r > 0.920). Poor correlation was observed in mixed
cells (r=0.005) especially in the high levels between Horiba and Sysmex. There was also
moderate correlation in mean platelet volume (MPV) between analyzers of Horiba and Sysmex
(r= 0.593 and r=0.572) at normal and high levels respectively.
Conclusion: The overall performance of the three analyzers is excellent. They agree well with
each other and can be used interchangeably with care in mixed cells and MPV.
Key words: Method comparison, performance evaluation, verification of hematology analyzers
Sysmex KX-21, Horiba ABX micros ES 60, Cell-Dyn 1800, hematology
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Keywords
Method comparison, Performance evaluatio, Verification of hematology analyzers Sysmex KX-21