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

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 (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.

Clinical utility of point of care glucose in the assessment of gestational diabetes: Prospective cohort study.

“…In total 230 pregnant women were included. The age and gestation were 34 (30-37) years and 28 (20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35) weeks respectively. Our hospital serves a large ethnically diverse catchment area.…”

Comparison of Venous and Capillary Sampling in Oral Glucose Testing for the Diagnosis of Gestational Diabetes Mellitus: A Diagnostic Accuracy Cross-Sectional Study Using Accu-Chek Inform II

“…They recommend the use of laboratory analysis when strict adherence to preanalytical sample handling can be applied; otherwise, POCT may be used for the diagnosis of GDM [25]. A recent Swedish study supported continuous use of POCT with the Hemocue device in GDM diagnostics [26]. Another recent study suggested that POCT using Accu-Chek can be used to obtain fasting values and to reduce overall waiting times for patients [27].…”

Peculiarities of Glucose Molecules Destruction under Irradiation at the M-30 Microtron (12.5 MeV): Mass Spectrometric Studies

“…However, such data for monosaccharide molecules, before and after the action of ionizing radiation, are practically absent. One should be emphasized that mass spectrometry methods are widely used in clinical medicine [25][26][27]. Special attention is paid to determining glucose concentration using isotope dilution mass spectrometry [28].…”