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Disregarded Measurement Uncertainty Contributions and Their Magnitude in Measuring Plasma Glucose.

Authors
  • Petersmann, Astrid1, 2
  • Macdonald, Rainer3
  • Nauck, Matthias1, 4
  • 1 Institute of Clinical Chemistry and Laboratory Medicine, University Medicine Greifswald, Greifswald, Germany. , (Germany)
  • 2 Institute of Clinical Chemistry and Laboratory Medicine, University Oldenburg, Oldenburg, Germany. , (Germany)
  • 3 Physikalisch-Technische Bundesanstalt (PTB), Berlin, Germany. , (Germany)
  • 4 German Center for Cardiovascular Research (DZHK), partner site Greifswald, Germany. , (Germany)
Type
Published Article
Journal
Journal of Diabetes Science and Technology
Publisher
SAGE Publications
Publication Date
Jan 01, 2022
Volume
16
Issue
1
Pages
161–167
Identifiers
DOI: 10.1177/1932296820966353
PMID: 33218279
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Each measurement is subject to measurement uncertainty (MU). Consequently, each measurement of plasma glucose concentration used for diagnosis and monitoring of diabetes mellitus (DM) is affected. Although concepts and methods of MU are well established in many fields of science and technology, they are presently only incompletely implemented by medical laboratories, neglecting MU of target values of internal quality control (IQC) materials. An empirical and practical approach for the estimation of MU based on the analysis of routine IQC using control samples with assigned target values is presented. Its feasibility is demonstrated exemplarily by analyzing IQC data from one year obtained for glucose employing the hexokinase method with IQC of two different concentrations. Combined relative extended (k = 2) MU comprising bias, coefficient of variation (CV), and MU of the target values assigned to control materials were about 9% with a lower (~ 56 mg/dL; ~3.1 mmol/L) and 8% with a higher (~ 346 mg/dL; ~19.2 mmol/L) concentration sample, analyzing IQC of one year from three different devices. Estimation of MU in this study is quite reliable due to the large number of IQC data from one year. The MU of the target values of the commercial control material in this study was considerably larger than other MU contributions, ie, standard deviation and bias. In the future, the contribution of MU of commercial IQC should be addressed more carefully and technologies to measure glucose should be geared toward smaller MU possible, as needed, especially for glucose concentration measurements in diagnosis and management of DM.

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