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Disregarded Measurement Uncertainty Contributions and Their Magnitude in Measuring Plasma Glucose

Astrid Petersmann1,2, Rainer Macdonald3, Matthias Nauck1,4

  • 1Institute of Clinical Chemistry and Laboratory Medicine, University Medicine Greifswald, Greifswald, Germany.

Journal of Diabetes Science and Technology
|November 21, 2020
PubMed
Abstract

Insights

Measurement uncertainty (MU) affects diabetes mellitus (DM) diagnosis. This study presents a practical method to estimate MU for plasma glucose, finding target value uncertainty in quality control materials is a significant factor.

Area of Science:

  • Clinical Chemistry
  • Metrology
  • Laboratory Medicine

Background:

  • All measurements, including plasma glucose, have measurement uncertainty (MU).
  • MU impacts diabetes mellitus (DM) diagnosis and monitoring.
  • Medical labs often neglect MU of internal quality control (IQC) target values.

Purpose of the Study:

  • To present a practical method for estimating MU in routine IQC.
  • To demonstrate the feasibility of this MU estimation approach.
  • To highlight the impact of IQC target value MU on glucose measurements.

Main Methods:

  • Empirical estimation of MU using routine IQC data.
  • Analysis of one year of glucose IQC data (hexokinase method).
  • Inclusion of bias, CV, and IQC target value MU in combined MU.

Main Results:

  • Combined relative extended MU was ~9% (low glucose) and ~8% (high glucose).
  • MU estimation was based on one year of IQC data from three devices.
  • MU of commercial IQC target values was larger than other MU components.

Conclusions:

  • The presented MU estimation method is reliable due to extensive IQC data.
  • MU of commercial IQC target values is a critical, often overlooked, factor.
  • Future efforts should focus on reducing IQC target value MU for accurate glucose measurement in DM management.
Keywords:
analytical measurementsbiasimprecisionmetrological controlsquality controluncertainty of measurement

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