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Background: A centrifuge-based device has been introduced to the Samsung Blood Analyzer (SBA). The verifica-tion of this analyzer is essential to meet the ISO15189 standard.
Methods: Analytical performance was evaluated according to the NCCLS EP05-A method. The results of plasma samples were compared between the SBA and a Hitachi 917 analyzer according to the NCCLS EP09-A2-IR meth-od. Percent recovery was determined via analysis of original control serum and spiked serum.
Results: Within-run precision was found to be 0.00 - 6.61% and 0.96 - 5.99% in normal- and abnormal-level as-says, respectively, while between-run precision was 1.31 - 9.09% and 0.89 - 6.92%, respectively. The correlation coefficients (r) were > 0.990. The SBA presented analytical accuracy at 96.64 ± 3.39% to 102.82 ± 2.75% and 98.31 ± 4.04% to 103.61 ± 8.28% recovery, respectively.
Conclusions: The results obtained verify that all of the 13 tests performed using the SBA demonstrates good and reliable precision suitable for use in qualified clinical chemistry laboratory service.
DOI: 10.7754/Clin.Lab.2012.120705
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