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
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 th...
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| Format: | Article |
| Language: | English |
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Wiley
2020-01-01
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| Series: | Journal of Diabetes Research |
| Online Access: | http://dx.doi.org/10.1155/2020/7937403 |
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| author | Karl Kristensen Anne-Marie Wangel Anastasia Katsarou Nael Shaat David Simmons Helena Fadl Kerstin Berntorp |
| author_facet | Karl Kristensen Anne-Marie Wangel Anastasia Katsarou Nael Shaat David Simmons Helena Fadl Kerstin Berntorp |
| author_sort | Karl Kristensen |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-94c5e09650124721bacd17ec8d2e6eab |
| institution | Kabale University |
| issn | 2314-6745 2314-6753 |
| language | English |
| publishDate | 2020-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Diabetes Research |
| spelling | doaj-art-94c5e09650124721bacd17ec8d2e6eab2025-02-03T01:25:17ZengWileyJournal of Diabetes Research2314-67452314-67532020-01-01202010.1155/2020/79374037937403Diagnosis of Gestational Diabetes Mellitus with Point-of-Care Methods for Glucose versus Hospital Laboratory Method Using Isotope Dilution Gas Chromatography-Mass Spectrometry as ReferenceKarl Kristensen0Anne-Marie Wangel1Anastasia Katsarou2Nael Shaat3David Simmons4Helena Fadl5Kerstin Berntorp6Department of Obstetrics and Gynecology, Skåne University Hospital, Malmö, SwedenFaculty of Health and Society, Department of Care Science, Malmö University, Malmö, SwedenDepartment of Endocrinology, Skåne University Hospital, Malmö, SwedenDepartment of Endocrinology, Skåne University Hospital, Malmö, SwedenMacarthur Clinical School, Western Sydney University, Campbelltown, AustraliaDepartment of Obstetrics and Gynecology, Faculty of Medicine and Health, Örebro University, Örebro, SwedenDepartment of Endocrinology, Skåne University Hospital, Malmö, SwedenBackground. 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.http://dx.doi.org/10.1155/2020/7937403 |
| spellingShingle | Karl Kristensen Anne-Marie Wangel Anastasia Katsarou Nael Shaat David Simmons Helena Fadl 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 Journal of Diabetes Research |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | http://dx.doi.org/10.1155/2020/7937403 |
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