TITLE:
Verification of Quantitative Analytical Methods for Routine Clinical Biochemistry Analytes on Alinity ci Series and Architect ci 8200 at the Mohammed VI University Hospital of Oujda (Morocco)
AUTHORS:
Oussama Rahhab, Dounia El-Moujtahide, El-Houcine Sebbar, Mohammed Choukri
KEYWORDS:
Analytical Verification, Clinical Biochemistry, ISO 15189, Accreditation
JOURNAL NAME:
Open Access Library Journal,
Vol.12 No.3,
March
25,
2025
ABSTRACT: This study aimed to independently assess the analytical performance of 56 routine clinical biochemistry parameters on the ABBOTT Alinity ci Series and Architect ci 8200 automated systems, ensuring compliance with ISO 15189 standards. The verification followed Scope A criteria from the Medical Biology Method Verification/Validation Guide, focusing on repeatability and reproducibility. The coefficient of variation (CV) was compared to limits established by recognized learned societies such as the French Society of Clinical Biology (SFBC). Three concentration levels (low, medium, high) were analyzed for each parameter to assess precision. The results demonstrated satisfactory repeatability and reproducibility across all tested analytes, confirming the reliability of the automated systems. The obtained CV values were within acceptable limits, validating the precision of the analytical methods. This verification process ensures adherence to regulatory and normative requirements, reinforcing the laboratory’s commitment to quality assurance. By systematically evaluating analytical performance, the study contributes to the optimization of routine biochemical analysis, enhancing result reliability for clinical decision-making. Furthermore, these findings support the Central Laboratory Department’s ongoing efforts to implement robust quality management systems. The laboratory aims to be one of the first public hospital laboratories in the country to achieve ISO 15189 accreditation, demonstrating its dedication to mastering advanced analytical systems and ensuring high standards in patient care.