A comparative evaluation of the analytical performances of Capillarys 2 Flex Piercing, Tosoh HLC-723 G8, Premier Hb9210, and Roche Cobas c501 Tina-quant Gen 2 analyzers for HbA1c determination

作者：Xiaobin Wu, Yan Chao, Zemin Wan, Yunxiu Wang, Yan Ma, Peifeng Ke, Xinzhong Wu, Jianhua Xu, Junhua Zhuang, Xianzhang Huang · 发表于：Biochemia Medica · 年份：2016 · DOI：10.11613/bm.2016.039 · 被引用次数：27 · 研究领域：Clinical Laboratory Practices and Quality Control、Nitric Oxide and Endothelin Effects、Electrochemical sensors and biosensors

Introduction: Haemoglobin A 1c (HbA 1c ) is widely used in the management of diabetes.Therefore, the reliability and comparability among different analytical methods for its detection have become very important. Materials and methods:A comparative evaluation of the analytical performances (precision, linearity, accuracy, method comparison, and interferences including bilirubin, triglyceride, cholesterol, labile HbA 1c (LA 1c ), vitamin C, aspirin, fetal haemoglobin (HbF), and haemoglobin E (Hb E)) were performed on Capillarys 2 Flex Piercing (Capillarys 2FP) (Sebia, France), Tosoh HLC-723 G8 (Tosoh G8) (Tosoh, Japan), Premier Hb9210 (Trinity Biotech, Ireland) and Roche Cobas c501 (Roche c501) (Roche Diagnostics, Germany).Results: A good precision was shown at both low and high HbA 1c levels on all four systems, with all individual CVs below 2% (IFCC units) or 1.5% (NGSP units).Linearity analysis for each analyzer had achieved a good correlation coefficient (R 2 > 0.99) over the entire range tested.The analytical bias of the four systems against the IFCC targets was less than ± 6% (NGSP units), indicating a good accuracy.Method comparison showed a great correlation and agreement between methods.Very high levels of triglycerides and cholesterol (≥ 15.28 and ≥ 8.72 mmol/L, respectively) led to falsely low HbA 1c concentrations on Roche c501.Elevated HbF induced false HbA 1c detection on Capillarys 2FP (> 10%), Tosoh G8 (> 30%), Premier Hb9210 (> 15%), and Roche c501 (> 5%).On To...