Comparison of point-of-care-testing glucose meters with standard laboratory measurement of the 50g-glucose-challenge test (GCT) during pregnancy
Standard
Comparison of point-of-care-testing glucose meters with standard laboratory measurement of the 50g-glucose-challenge test (GCT) during pregnancy. / Buhling, Kai J; Henrich, Wolfgang; Kjos, Siri L; Siebert, Gerda; Starr, Elizabeth; Dreweck, Christine; Stein, Ursula; Dudenhausen, Joachim W.
in: CLIN BIOCHEM, Jahrgang 36, Nr. 5, 01.07.2003, S. 333-7.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Comparison of point-of-care-testing glucose meters with standard laboratory measurement of the 50g-glucose-challenge test (GCT) during pregnancy
AU - Buhling, Kai J
AU - Henrich, Wolfgang
AU - Kjos, Siri L
AU - Siebert, Gerda
AU - Starr, Elizabeth
AU - Dreweck, Christine
AU - Stein, Ursula
AU - Dudenhausen, Joachim W
PY - 2003/7/1
Y1 - 2003/7/1
N2 - OBJECTIVES: Although glucose meters are well-established instruments for self-monitoring blood glucose levels, diagnostic and screening procedures should be performed using standard laboratory methods. In addition to standard laboratory methods, HemoCue is authorized for screening and diagnostic purposes in Germany. The rapid development of other glucose meters makes it necessary to re-evaluate this recommendation. Our objective was to test the usefulness of glucose meters in screening pregnant patients for gestational diabetes.METHODS: The 50-g glucose challenge test was administered to one hundred and ninety-three pregnant patients whose blood glucose levels were then simultaneously measured with five portable meters and the HemoCue. The results were compared to our standard method (Hexokinase). A cut-off of 7.8 mmol/L was used and sensitivity, specificity, accuracy, the Youden index, and the Kappa index were calculated. The tests were performed by well-trained personnel (C.D. and U.S.).RESULTS: 1212 measurements were performed on 193 patients. All glucose meters showed a very good correlation (r > 0.90). None of the measurements showed an extreme deviation necessitating the error grid analysis. The GlucoTouch (5.93% +/- 7.4) and the HemoCue (-9.04% +/- 5.9) showed a mean deviation greater than 5%. None of the meters had a mean deviation greater than 10%. The accuracy fluctuated between 0.85 and 0.94. The Kappa index was between 66 to 85. In our clinical trial, the Accu-Chek, Glucotouch, OneTouch, and Precision demonstrated greater accuracy and a higher Kappa index than the HemoCue.CONCLUSIONS: Our data showed good concordance in statistical and clinical parameters for most of the six glucose meters. The HemoCue, recommended as a standard method in several countries, did not show better concordance than most of the tested glucose meters. When used by well-trained personnel, the accuracy of the Accu-Chek, Glucotouch, One-Touch, and Precision was acceptable for use in gestational diabetes screening.
AB - OBJECTIVES: Although glucose meters are well-established instruments for self-monitoring blood glucose levels, diagnostic and screening procedures should be performed using standard laboratory methods. In addition to standard laboratory methods, HemoCue is authorized for screening and diagnostic purposes in Germany. The rapid development of other glucose meters makes it necessary to re-evaluate this recommendation. Our objective was to test the usefulness of glucose meters in screening pregnant patients for gestational diabetes.METHODS: The 50-g glucose challenge test was administered to one hundred and ninety-three pregnant patients whose blood glucose levels were then simultaneously measured with five portable meters and the HemoCue. The results were compared to our standard method (Hexokinase). A cut-off of 7.8 mmol/L was used and sensitivity, specificity, accuracy, the Youden index, and the Kappa index were calculated. The tests were performed by well-trained personnel (C.D. and U.S.).RESULTS: 1212 measurements were performed on 193 patients. All glucose meters showed a very good correlation (r > 0.90). None of the measurements showed an extreme deviation necessitating the error grid analysis. The GlucoTouch (5.93% +/- 7.4) and the HemoCue (-9.04% +/- 5.9) showed a mean deviation greater than 5%. None of the meters had a mean deviation greater than 10%. The accuracy fluctuated between 0.85 and 0.94. The Kappa index was between 66 to 85. In our clinical trial, the Accu-Chek, Glucotouch, OneTouch, and Precision demonstrated greater accuracy and a higher Kappa index than the HemoCue.CONCLUSIONS: Our data showed good concordance in statistical and clinical parameters for most of the six glucose meters. The HemoCue, recommended as a standard method in several countries, did not show better concordance than most of the tested glucose meters. When used by well-trained personnel, the accuracy of the Accu-Chek, Glucotouch, One-Touch, and Precision was acceptable for use in gestational diabetes screening.
KW - Adult
KW - Blood Glucose
KW - Blood Glucose Self-Monitoring
KW - Female
KW - Glucose Tolerance Test
KW - Hexokinase
KW - Humans
KW - Point-of-Care Systems
KW - Pregnancy
M3 - SCORING: Journal article
C2 - 12849863
VL - 36
SP - 333
EP - 337
JO - CLIN BIOCHEM
JF - CLIN BIOCHEM
SN - 0009-9120
IS - 5
ER -