Lab Med Online.  2022 Oct;12(4):278-284. 10.47429/lmo.2022.12.4.278.

Performance Evaluation of Urine Dipstick Analyzer CYBOW R-600S

• Kim WJ
• Choi H
• Yu S
• Park MS
• Lee J
• Lee SM

• KMID: 2538615
• DOI: http://doi.org/10.47429/lmo.2022.12.4.278

Abstract

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.

Keyword

Urinalysis; Autoanalyzer; Albumin-creatinine ratio; Albumin-to-protein ratio

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