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评估血糖自我监测系统的分析性能:性能评估概念及计量关键术语的定义

Assessing the analytical performance of systems for self-monitoring of blood glucose: concepts of performance evaluation and definition of metrological key terms.

作者信息

Schnell Oliver, Hinzmann Rolf, Kulzer Bernd, Freckmann Guido, Erbach Michael, Lodwig Volker, Heinemann Lutz

机构信息

Forschergruppe Diabetes e.V., Helmholtz Center Munich, Ingolstaedter Landstrasse 1, 85764 Munich-Neuherberg, Germany.

出版信息

J Diabetes Sci Technol. 2013 Nov 1;7(6):1585-94. doi: 10.1177/193229681300700619.

Abstract

Reliability of blood glucose (BG) measurements is a prerequisite for successful diabetes management. Publications on the evaluation of self-monitored glucose values, however, are frequently characterized by a confusion in terminology. We provide an inventory of key terms such as accuracy, trueness, precision, traceability, calibration, and matrix effect to avoid future misunderstanding. Definitions are taken from the metrological literature and international norms and explained in a language intended for nonspecialists in metrology. The terms are presented in light of the need to apply generally accepted definitions. In addition, a description of requirements and components for a sound evaluation of BG measurement systems is presented. These factors will also enable improvement in future comparisons of study results.

摘要

血糖(BG)测量的可靠性是成功管理糖尿病的前提条件。然而,关于自我监测血糖值评估的出版物常常存在术语混淆的问题。我们提供了一份关键术语清单,如准确性、真实性、精密度、可追溯性、校准和基质效应,以避免未来出现误解。定义取自计量学文献和国际规范,并用适合计量学非专业人士的语言进行解释。这些术语是根据应用普遍接受定义的需要而呈现的。此外,还介绍了对BG测量系统进行合理评估的要求和组成部分。这些因素也将有助于改进未来研究结果的比较。

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