title: Evaluation of the Glucometer Elite XL device for screening for neonatal hypoglycaemia.
abstract: To prevent persistent neurodevelopment and physical growth deficits 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 difference 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 differences between measurement pairs of both assays versus the haematocrit were negligible. With a cut-off for hypoglycaemia at 2.6 mmol/l glucose in haemolysed blood, the sensitivity of the POCT device was 0.63 and specificity was 0.98. Raising the cut-off of the Glucometer Elite XL to 3.2 mmol/l, the sensitivity and specificity incremented to 1.0 and 0.89, respectively.
  
  
  CONCLUSIONS
  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-off for hypoglycaemia recognition to a safe threshold of 3.2 mmol/l. However, hypoglycaemia has to be confirmed by a valid glucose measurement in the clinical laboratory.
authors.affiliation: Department of Neonatology and Paediatric Intensive Care, University Children's Hospital, Soldmannstrasse 15, 17489 Greifswald, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Michel
authors.forename: Helmut
authors.initials: H
authors.lastname: Küster
authors.forename: Alexander
authors.initials: A
authors.lastname: Krebs
authors.forename: Ingrid
authors.initials: I
authors.lastname: Kadow
authors.forename: Wilfried
authors.initials: W
authors.lastname: Paul
authors.forename: Matthias
authors.initials: M
authors.lastname: Nauck
authors.forename: Christoph
authors.initials: C
authors.lastname: Fusch
mesh_terms: D001774:Blood Chemical Analysis / Q000295:instrumentation; D001786:Blood Glucose / Q000032:analysis*; D004864:Equipment and Supplies / Q000592:standards; D006400:Hematocrit; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000175:diagnosis*; D007231:Infant, Newborn; D015997:Neonatal Screening / Q000295:instrumentation*; D019095:Point-of-Care Systems; D012044:Regression Analysis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D001786:Blood Glucose