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Review
. 2013 Nov 1;7(6):1585-94.
doi: 10.1177/193229681300700619.

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

Oliver Schnell  1 , Rolf Hinzmann, Bernd Kulzer, Guido Freckmann, Michael Erbach, Volker Lodwig, Lutz Heinemann
Affiliations
Review

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

Oliver Schnell et al. J Diabetes Sci Technol. .

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.

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Figures

Figure 1.
Figure 1.
Precision, trueness, and accuracy of measurement.
Figure 2.
Figure 2.
Example of a traceability chain (here depicted for Roche BG systems). IFCC, International Federation of Clinical Chemistry and Laboratory Medicine.
Figure 3.
Figure 3.
The Clarke error grid.
Figure 4.
Figure 4.
The Parkes error grid.
Figure 5.
Figure 5.
Accepted BG results according to (A) ISO 15197:2003 and (B) ISO 15197:2013. Requirements of the revised ISO 15197 provided, more results fall outside the accepted range.
See this image and copyright information in PMC

References

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Publication types

MeSH terms