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Kerstin Berntorp

Kerstin Berntorp

Adjunct professor

Kerstin Berntorp

Diagnosis of Gestational Diabetes Mellitus with Point-of-Care Methods for Glucose versus Hospital Laboratory Method Using Isotope Dilution Gas Chromatography-Mass Spectrometry as Reference

Author

  • Karl Kristensen
  • Anne Marie Wangel
  • Anastasia Katsarou
  • Nael Shaat
  • David Simmons
  • Helena Fadl
  • Kerstin Berntorp

Summary, in English

Background. In Sweden, both glucose analyzers in accredited laboratories and point-of-care glucose devices are used for gestational diabetes mellitus (GDM) diagnosis. The aim of this study was to compare the diagnostic performance of the HemoCue Glucose 201+ (HC201+) and RT (HC201RT) systems with that of the hospital central laboratory hexokinase method (CL) based on lyophilized citrate tubes, using the isotope dilution gas chromatography-mass spectrometry (ID GC-MS) as reference. Methods. A 75 g oral glucose tolerance test was performed on 135 women screened positive for GDM. Diagnosis was based on the World Health Organization 2013 diagnostic thresholds for fasting (n=135), 1 h (n=52), and 2 h (n=135) glucose measurements. Bland-Altman analysis and surveillance error grids were used to evaluate analytical and clinical accuracy. Results. Significantly more women were diagnosed with GDM by HC201+ (80%) and CL (80%) than with the reference (65%, P<0.001) based on fasting and/or 2 h thresholds, whereas the percentage diagnosed by HC201RT (60%) did not differ significantly from the reference. In Bland-Altman analysis, a positive bias was observed for HC201+ (4.2%) and CL (6.1%) and a negative bias for HC201RT (-1.8%). In the surveillance error grid, 95.9% of the HC201+ values were in the no-risk zone as compared to 98.1% for HC201RT and 97.5% for CL. Conclusions. A substantial positive bias was found for CL measurements resulting in overdiagnosis of GDM. Our findings suggest better performance of HC201RT than HC201+ in GDM diagnosis. The results may have possible implications for GDM diagnosis in Sweden and require further elucidation.

Department/s

  • Obstetrics and Gynaecology (Lund)
  • Diabetes and Celiac Unit
  • EXODIAB: Excellence in Diabetes Research in Sweden
  • Genomics, Diabetes and Endocrinology

Publishing year

2020

Language

English

Publication/Series

Journal of Diabetes Research

Volume

2020

Document type

Journal article

Publisher

Hindawi Limited

Topic

  • Obstetrics, Gynecology and Reproductive Medicine
  • Endocrinology and Diabetes
  • Medical Laboratory and Measurements Technologies

Status

Published

Research group

  • Diabetes and Celiac Unit
  • Genomics, Diabetes and Endocrinology

ISBN/ISSN/Other

  • ISSN: 2314-6745