首页> 外文OA文献 >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
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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

机译:毛细管2挠性穿孔,Tosoh HLC-723 G8,Premier Hb9210和Roche Cobas c501 Tina-quant Gen 2分析仪用于HbA1c测定的分析性能的比较评估

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摘要

Introduction: Haemoglobin A1c (HbA1c) 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 HbA1c (LA1c), 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 HbA1c 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 (R2 > 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 HbA1c concentrations on Roche c501. Elevated HbF induced false HbA1c detection on Capillarys 2FP (> 10%), Tosoh G8 (> 30%), Premier Hb9210 (> 15%), and Roche c501 (> 5%). On Tosoh G8, HbE induced an extra peak on chromatogram, and significantly lower results were reported. Conclusions: The four HbA1c methods commonly used with commercial analyzers showed a good reliability and comparability, although some interference may falsely alter the result.
机译:简介:血红蛋白A1c(HbA1c)被广泛用于糖尿病的治疗。因此,检测不同分析方法之间的可靠性和可比性变得非常重要。材料和方法:对分析性能(精度,线性,准确性,方法比较和干扰物,包括胆红素,甘油三酸酯,胆固醇,不稳定的HbA1c(LA1c),维生素C,阿司匹林,胎儿血红蛋白(HbF)和血红蛋白E)的比较评估(Hb E))在Capillarys 2 Flex Piercing(Capillarys 2FP)(法国塞尔维亚),Tosoh HLC-723 G8(Tosoh G8)(日本Tosoh),Premier Hb9210(Trinity Biotech,Ireland)和Roche Cobas c501(结果:在所有四个系统的低和高HbA1c水平下均显示出良好的精密度,所有单个CV均低于2%(IFCC单位)或1.5%(NGSP单位)。每个分析仪的线性分析在整个测试范围内均获得了良好的相关系数(R2> 0.99)。四个系统对IFCC目标的分析偏差小于±6%(NGSP单位),表明精度很高。方法比较显示方法之间的高度相关性和一致性。甘油三酸酯和胆固醇含量很高(分别约为15.28和8.72 mmol / L)导致Roche c501上的HbA1c浓度虚假降低。升高的HbF导致对毛细管2FP(> 10%),Tosoh G8(> 30%),Premier Hb9210(> 15%)和Roche c501(> 5%)的假HbA1c检测。在Tosoh G8上,HbE在色谱图上诱导了一个额外的峰,据报道结果明显偏低。结论:商用分析仪常用的四种HbA1c方法显示出良好的可靠性和可比性,尽管有些干扰可能会错误地改变结果。

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