title: Prospective evaluation of three point of care devices for glycemia measurement in a neonatal intensive care unit.
abstract: Hypoglycemia, if recurrent, may have severe consequences on cognitive and psychomotor development of neonates. Therefore, screening for hypoglycemia is a daily routine in every facility taking care of newborn infants. Point-of-care-testing (POCT) devices are interesting for neonatal use, as their handling is easy, measurements can be performed at bedside, demanded blood volume is small and results are readily available. However, such whole blood measurements are challenged by a wide variation of hematocrit in neonates and a spectrum of normal glucose concentration at the lower end of the test range. We conducted a prospective trial to check precision and accuracy of the best suitable POCT device for neonatal use from three leading companies in Europe. Of the three devices tested (Precision Xceed, Abbott; Elite XL, Bayer; Aviva Nano, Roche), Aviva Nano exhibited the best precision. None completely fulfilled the ISO-accuracy-criteria 15197: 2003 or 2011. Aviva Nano fulfilled these criteria in 92% of cases while the others were <87%. Precision Xceed reached the 95% limit of the 2003 ISO-criteria for values ≤4.2 mmol/L, but not for the higher range (71%). Although validated for adults, new POCT devices need to be specifically evaluated on newborn infants before adopting their routine use in neonatology.
authors.affiliation: Clinic of Neonatology, Department of Pediatrics, Centre Hospitalier Universitaire Vaudois (CHUV), University of Lausanne, CH-1011 Lausanne, Switzerland.
authors.forename: Corinne Stadelmann
authors.initials: CS
authors.lastname: Diaw
authors.forename: Nicolas
authors.initials: N
authors.lastname: Piol
authors.forename: Jocelyne
authors.initials: J
authors.lastname: Urfer
authors.forename: Dominique
authors.initials: D
authors.lastname: Werner
authors.forename: Matthias
authors.initials: M
authors.lastname: Roth-Kleiner
mesh_terms: D000367:Age Factors; D001786:Blood Glucose / Q000032:analysis*; D002648:Child; D006400:Hematocrit / Q000706:statistics & numerical data; D006801:Humans; D007003:Hypoglycemia / Q000097:blood* / Q000175:diagnosis; D007223:Infant; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal; D019095:Point-of-Care Systems / Q000592:standards*; D011446:Prospective Studies; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D001786:Blood Glucose
keywords: Blood glucose meter; Glycemia; Neonatal hypoglycemia; POCT; Point of care