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Axis-Shield Afinion糖化血红蛋白测量设备的准确性和精密度分析。

Analysis of the accuracy and precision of the Axis-Shield Afinion hemoglobin A1c measurement device.

作者信息

Little Randie R

机构信息

Department of Pathology & Anatomical Sciences, Columbia, Missouri 65212, USA.

出版信息

J Diabetes Sci Technol. 2012 Mar 1;6(2):387-8. doi: 10.1177/193229681200600225.

Abstract

Point-of-care (POC) hemoglobin A1c measurement is now used by many physicians to make more timely decisions on therapy changes. A few studies have highlighted the drawbacks of some POC methods, e.g., poor precision and lot-to-lot variability. Evaluating performance in the clinical setting is difficult because there is minimal proficiency testing data on POC methods. In this issue of Journal of Diabetes Science and Technology, Wood and colleagues describe their experience with the Afinion method in a pediatric clinic network, comparing these results to another POC method as well as to a laboratory high-performance liquid chromatography method. Although they conclude that the Afinion exhibits adequate performance, they do not evaluate lot-to-lot variability. As with laboratory methods, potential assay interferences must also be considered.

摘要

即时检测(POC)糖化血红蛋白测量现已被许多医生用于更及时地做出治疗调整决策。一些研究强调了某些POC方法的缺点,例如精密度差和批次间差异。在临床环境中评估性能很困难,因为关于POC方法的能力验证数据很少。在本期《糖尿病科学与技术杂志》中,伍德及其同事描述了他们在儿科诊所网络中使用阿菲尼翁方法的经验,将这些结果与另一种POC方法以及实验室高效液相色谱法进行了比较。尽管他们得出结论认为阿菲尼翁表现出足够的性能,但他们没有评估批次间差异。与实验室方法一样,还必须考虑潜在的分析干扰。

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本文引用的文献

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Point-of-care assays for hemoglobin A(1c): is performance adequate?血红蛋白A(1c)的即时检验:性能是否足够?
Clin Chem. 2011 Sep;57(9):1333-4. doi: 10.1373/clinchem.2011.165019. Epub 2011 Jun 28.

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