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Background: HbA1c is a biomarker for the diagnosis of type 2 diabetes (T2D) and prediabetes, in addition to its role in monitoring glycemic control. These indications require mastery of analytical performance. This study evaluated the analytical performance of the ADAMS A1C HA-8180V analyzer used in the biochemistry laboratory of Mohammed V Military Hospital in Rabat (Morocco).
Methods: This is a retrospective study conducted between April 2023 and April 2024. The results of daily internal quality control (IQC) and monthly external quality assessment (EQA) were used to calculate imprecision and accuracy. Three analytical-mathematical models based on the total acceptable error (TAE) were used: biological variation (BV), Sigma metrics (SM), and Model for Quality Targets (MQT) recommended by the IFCC (International Federation of Clinical Chemistry and Laboratory Medicine).
Results: The mean CVs of the IQC were 0.82% and 0.92% for levels 1 and 2, respectively, significantly lower than the 3.4% CV recommended by the state of the art. The mean relative bias of the EQA was 1.47%. According to the BV model, the "desirable" performance level predominated. According to the SM model, the majority of results exceeded 5 sigma. Applying the MQT model, all results exceeded the 2 sigma recommended by the IFCC.
Conclusions: The HbA1c results reported by the laboratory met the IFCC criteria for routine laboratories provid-ing T2D diagnosis and monitoring of diabetic patients.
DOI: 10.7754/Clin.Lab.2025.250318
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