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Eur J Pediatr (2005) 164: 660664 DOI 10.1007/s00431-005-1733-9
ORIGINAL PAPER
Andreas Michel Helmut Kuster Alexander Krebs Ingrid Kadow Wilfried Paul Matthias Nauck Christoph Fusch
Evaluation of the Glucometer Elite XL device for screening for neonatal hypoglycaemia
Received: 1 March 2005 / Revised: 31 May 2005 / Accepted: 1 June 2005 / Published online: 22 July 2005 Springer-Verlag 2005
Abstract To prevent persistent neurodevelopment and physical growth decits in neonatal care, it is mandatory to determine blood glucose levels as quickly and precisely as possible, preferably using micro-methods. However, most commercially available instruments have not been validated and approved for this purpose. The aim of this study was to validate the Glucometer Elite XL, a newly developed device for point-of-care testing (POCT). In samples from 869 newborn infants, glucose levels were simultaneously measured by the Glucometer Elite XL in whole blood and by an accepted clinical laboratory method in haemolysed blood using the ECA 2000 device. An acceptable method agreement was found between the POCT and the ECA 2000 method (mean dierence 0.013 mmol/l, SD 0.69). As determined by regression analysis (Passing-Bablok), the slope was 1.086 with a y-intercept of 0.4 mmol/l ( r =0.959, P <0.05). The dierences between measurement pairs of both assays versus the haematocrit were negligible. With a cut-o for hypoglycaemia at 2.6 mmol/l glucose in haemolysed blood, the sensitivity of the POCT device was 0.63 and specicity was 0.98. Raising the cut-o of the Glucometer Elite XL to 3.2 mmol/l, the sensitivity and specicity incremented to 1.0 and 0.89, respectively. Conclusion: The Glucometer Elite XL instrument can be recommended for point-of-care blood glucose measurement in newborn infants if its character as a screening method is taken into account. To compensate deviating results, we advise to shift its cut-o for hypoglycaemia recognition to a safe threshold of 3.2 mmol/l. However,
hypoglycaemia has to be conrmed by a valid glucose measurement in the clinical laboratory.
Keywords Blood glucose Haematocrit Hypoglycaemia Intensive care Neonatal Point-of-care systems
Abbreviations CV: coefcient of variation POCT: point-of-care testing ROC: receiver operating characteristics
Introduction Since glucose is the main source of energy for the brain metabolism in neonates, it is important to maintain adequate blood glucose levels, especially in preterm infants. In general, newborns are capable of metabolising ketone...