Fagnani Lorenza, De Angelis Simonetta, Bellio Pierangelo, Frascaria Patrizia, Tennina Rita, Alloggia Giovanni, Gentile Francesco, Piccirilli Alessandra, Perilli Mariagrazia, Celenza Giuseppe
Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, 67100 L'Aquila, Italy.
Clinical Laboratory, Regional Hospital "San Salvatore", 67100 L'Aquila, Italy.
Diagnostics (Basel). 2025 Apr 10;15(8):969. doi: 10.3390/diagnostics15080969.
: The determination of glycated haemoglobin (HbA1c) is a cornerstone of the diagnosis and management of diabetes mellitus, serving as a reliable biomarker for assessing long-term glycaemic control. While high-performance liquid chromatography (HPLC) is regarded as the gold standard for HbA1c measurement, its widespread adoption is limited by high costs, operational complexity, and resource requirements. Alternative methodologies, including immunoturbidimetric assays, have garnered interest as practical solutions. This study evaluates the analytical performance of an immunoturbidimetric method for HbA1c determination and its comparability with a validated HPLC method. : The evaluation process was conducted in accordance with the Clinical and Laboratory Standards Institute (CLSI) guidelines. The results from 178 human sample leftovers, covering the medical decision range, were compared with those obtained using the HPLC-based Menarini ADAMS A1c HA-8180T system. The analytical performance regarding repeatability and within-laboratory imprecision was also assessed. The probability risk of misinterpreting the analytical results was also calculated. : The Passing-Bablok regression indicated a strong correlation between the two methods, with a slope of 1.00 (95% CI: 1.00 to 1.04). The Bland-Altman analysis confirmed minimal systematic differences, showing a mean bias of -0.07% for NGSP and -0.74 mmol/mol for IFCC, both falling within the predefined total allowable error (ATE) limits. Imprecision studies demonstrated excellent repeatability and intermediate precision, with coefficients of variation () ranging from 0.68% to 2.4% across all levels. The risk assessment of diagnostic misinterpretation indicated minimal deviation from an ideal analytical system, in which the measurement uncertainty was regarded as zero. : The findings establish the immunoturbidimetric method as a reliable and cost-effective alternative to HPLC for routine HbA1c determination. Its strong analytical performance, combined with operational efficiency, makes it a valuable tool for laboratories, particularly in resource-limited settings, enhancing access to high-quality diabetes monitoring.
糖化血红蛋白（HbA1c）的测定是糖尿病诊断和管理的基石，是评估长期血糖控制的可靠生物标志物。虽然高效液相色谱法（HPLC）被视为HbA1c测量的金标准，但其广泛应用受到高成本、操作复杂性和资源需求的限制。包括免疫比浊法在内的替代方法作为实用解决方案受到了关注。本研究评估了一种免疫比浊法测定HbA1c的分析性能及其与经过验证的HPLC方法的可比性。
评估过程按照临床和实验室标准协会（CLSI）指南进行。将178份涵盖医学决策范围的人体样本剩余物的结果与使用基于HPLC的美纳里尼ADAMS A1c HA - 8180T系统获得的结果进行比较。还评估了重复性和实验室内不精密度方面的分析性能。还计算了错误解读分析结果的概率风险。
Passing - Bablok回归表明两种方法之间存在强相关性，斜率为1.00（95%置信区间：1.00至1.04）。Bland - Altman分析证实系统差异极小，NGSP的平均偏差为 - 0.07%，IFCC的平均偏差为 - 0.74 mmol/mol，均在预定义的总允许误差（ATE）范围内。不精密度研究表明重复性和中间精密度极佳，所有水平的变异系数（CV）范围为0.68%至2.4%。诊断错误解读的风险评估表明与理想分析系统的偏差极小，在理想分析系统中测量不确定度被视为零。
研究结果表明，免疫比浊法是常规HbA1c测定中一种可靠且经济高效的替代HPLC的方法。其强大的分析性能与操作效率相结合，使其成为实验室，特别是资源有限环境中的宝贵工具，可增强高质量糖尿病监测的可及性。
