Verification of the analytical performance of the urinary creatinine assay on Abbott Architect ci8200
1 Faculty of Medicine and Pharmacy of Oujda, Mohammed First University, Morocco.
2 Central Laboratory, Mohammed VI University Hospital of Oujda, Morocco.
Research Article
Open Access Research Journal of Biology and Pharmacy, 2021, 13(01), 001-005.
Article DOI: 10.53022/oarjbp.2025.13.1.0042
Publication history:
Received on 13 November 2024; revised on 01 January 2025; accepted on 04 January 2025
Abstract:
The urinary creatinine assay is a pivotal diagnostic tool for assessing kidney function, hydration status, and muscle metabolism. This study evaluated the analytical performance of the urinary creatinine assay method using an Abbott kit on the Architect ci8200® automated system in the biochemistry laboratory of CHU Mohammed VI, Oujda. Method verification was conducted in two phases: intermediate fidelity testing using internal quality controls and repeatability testing on patient urine samples across low and high creatinine concentration levels.
The results demonstrated excellent analytical performance, with coefficients of variation (CV) for intermediate fidelity (CV1 = 1,95% and CV2 = 1.46%) and repeatability (CV1 = 0.78% and CV2 = 0.87%) well within the limits established by the French Society of Clinical Biology (SFBC). Levey-Jennings charts illustrated consistent and robust performance.
This method also underwent a comparative analysis using the Bland-Altman diagram, which confirmed its accuracy and precision relative to established standards. These findings underscore the reliability of the urinary creatinine assay method, ensuring high-quality diagnostic outcomes.
Keywords:
Creatinine urinary; Reproductibility; Repeatability; Quality
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