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

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

Research output: Contribution to journalArticlepeer-review

8 Citations (Scopus)

Abstract

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 (), 1 h (), and 2 h () 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%, ) 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.
Original languageEnglish
Article number7937403
Number of pages10
JournalJournal of Diabetes Research
Volume2020
DOIs
Publication statusPublished - 2020

Open Access - Access Right Statement

© 2020 Karl Kristensen et al. This is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Keywords

  • diabetes in pregnancy
  • gas chromatography
  • mass spectrometry
  • point-of-care testing

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this