1. Assessing the Analytical Performance of Systems for Self-Monitoring of Blood Glucose: Concepts of Performance Evaluation and Definition of Metrological Key Terms
- Author
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Michael Erbach, Lutz Heinemann, Bernd Kulzer, Rolf Hinzmann, Volker Lodwig, Guido Freckmann, and Oliver Schnell
- Subjects
Blood Glucose ,Traceability ,business.industry ,Blood Glucose Self-Monitoring ,Endocrinology, Diabetes and Metabolism ,Biomedical Engineering ,Reproducibility of Results ,Bioengineering ,Review Article ,Reference Standards ,Terminology ,Metrology ,Risk analysis (engineering) ,Diabetes management ,Terminology as Topic ,Calibration ,Diabetes Mellitus ,Internal Medicine ,Self-monitoring ,Humans ,Medicine ,business ,Reliability (statistics) - 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.
- Published
- 2013