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 = 135), 1 h (n = 135), 1 h (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.
Highlights
The oral glucose tolerance test (OGTT) is the gold standard for diagnosis of gestational diabetes mellitus (GDM)
In Malmö, screening for GDM with a 75 g OGTT is offered to all women in the twenty-eighth week of gestation at their local antenatal clinic, and in gestational week 12 if they have a history of GDM or macrosomia in previous pregnancies, a first-degree relative with diabetes, or body mass index ðBMIÞ ≥ 35 kg/m2
During the recruitment period to the CDC4G study, women who screened positive for GDM at their local antenatal clinic in the catchment area of Malmö were referred to the specialist antenatal clinic at the hospital for a diagnostic OGTT
Summary
The oral glucose tolerance test (OGTT) is the gold standard for diagnosis of gestational diabetes mellitus (GDM). In 2015, the Swedish National Board of Health and Welfare (SNBHW) reviewed the evidence of the current Swedish and the World Health Organization (WHO) diagnostic criteria for GDM and recommended a shift to the lower WHO diagnostic thresholds [1] These are based on the thresholds from the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study that identified pregnancies in which the risks of various adverse outcomes were increased, with an adjusted odds ratio of 1.75 compared to mean glucose concentrations [2, 3]. Thresholds have been based on either venous or capillary blood sampling, and for glucose analysis, either hospital laboratory methods or point-of-care (POC) glucose instruments have been used. The results may have possible implications for GDM diagnosis in Sweden and require further elucidation
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