Verification of the analytical performance of the serum glucose assay on the Abbott Alinity c® analyzer

Background: Accurate determination of serum glucose is essential for the diagnosis and monitoring of diabetes mellitus. In accordance with ISO 15189 requirements, clinical laboratories must verify the analytical performance of measurement procedures prior to routine use.
Objective: To verify the repeatability and reproducibility of the serum glucose assay performed on the Abbott Alinity c® analyzer using an enzymatic hexokinase method.
Methods: A precision verification study was conducted over a 30-day period in the biochemistry laboratory of the Military Hospital of Marrakech. Three levels of commercial quality control materials (low, medium, and high) were analyzed. Repeatability was evaluated by 30 consecutive measurements for each level on the same day, while reproducibility was assessed by daily measurements over 30 days. Mean values, standard deviation (SD), and coefficient of variation (CV) were calculated and compared with recommended acceptance criteria [3–5].
Results: Repeatability CVs were 0.50%, 0.34%, and 0.40% for low, medium, and high control levels, respectively. Reproducibility CVs ranged from 0.96% to 1.27%. All CVs were below the recommended limits.
Conclusion: The serum glucose assay on the Abbott Alinity c® analyzer demonstrates excellent analytical precision and is suitable for routine clinical use.