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KMID : 1100820220120040278
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Laboratory Medicine Online
2022 Volume.12 No. 4 p.278 ~ p.284
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Performance Evaluation of Urine Dipstick Analyzer CYBOW R-600S
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Kim Won-Joo
Choi Hyun-Ji
Yu Shin-Ae
Park Min-Soon
Lee Ji-Young
Lee Sun-Min
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Abstract
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Background: We evaluated the performance of the currently marketed semi-automated urine analyzer CYBOW R-600S.
Methods: Precision was measured using two commercially available quality-control materials. A total of 300 urine samples were used to compare the results of CYBOW R-600S (DFI Co., Korea), UC-3500 (Sysmex, Japan), and AU5800 (Beckman Coulter, USA). uACR and uPCR were also calculated to evaluate the analytical performance of the CYBOW R-600S.
Results: The grade agreement rates of the 12 parameters for within-run and between-day precision were above 97.5%, except for high-level creatinine, for which it was 94.4% between days. Compared to the results of UC-3500 and AU5800, the agreement within the ±1 grade difference rate was 100% for all parameters, except for SG (99.7%), pH (99.3%), protein (96.7%), leukocyte esterase (99.3%), and albumin (99.7%). The concordance rates of uACR and uPCR between the CYBOW R-600S and the reference analyzers were 95.0% and 96.3%, respectively. The corresponding kappa coefficients were 0.914 (95% CI, 0.872?0.956) and 0.819 (95% CI, 0.724?0.915), respectively. The sensitivity, positive predictive value (PPV), and negative predictive value (NPV) of uACR converted from the quantitative value were higher than those of uPCR.
Conclusions: CYBOW R-600S showed good precision and concordance rate performance within ±1 grade difference when compared with UC-3500 and AU5800. Therefore, we conclude that CYBOW R-600S is suitable for clinical applications.
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KEYWORD
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Urinalysis, Autoanalyzer, Albumin-creatinine ratio, Albumin-to-protein ratio
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