title: Validation of a new generation POCT glucose device with emphasis on aspects important for glycemic control in the hospital care.
abstract: BACKGROUND
  Point-of-care (POC) glucose devices are widely used for insulin-dosage decision-making although such an application is not always permitted. In this study, we have evaluated a new generation of POC glucose device, the HemoCue(®) Glucose 201DMRT (201DMRT), for its suitability for (tight) glycemic control.
  
  
  METHODS
  This study was performed according to the CLSI/STARD criteria. The 201DMRT was compared to the laboratory hexokinase glucose method (Siemens Dimension Vista(®)). The variation among different POC devices and cuvette lot numbers was examined. Additionally, the influence of the partial pressure of oxygen and hematocrit on glucose measurement was investigated.
  
  
  RESULTS
  The 201DMRT showed a good agreement with the laboratory reference method. This was examined using Deming regression analysis, percentage Bland-Altman plot and a modified Clarke-error grid. The total analytical error at the clinically critical glucose concentrations of 5.6, 7.0 and 11.1 mmol/L (101, 126 and 200 mg/dL) was 6.4%, 4.3% and 3.0%, respectively. The total error among the different POC devices and among different cuvette lot numbers was <6.5%. Glucose measurements on the 201DMRT were not affected by changes in partial pressure of oxygen, whereas changes in hematocrit had influence on the results (3.4% for every 0.10 L/L change in hematocrit).
  
  
  CONCLUSIONS
  The 201DMRT device can be used for glycemic control based on analytical results presented. However, the clinical applicability for tight glycemic control must be confirmed in a clinical study.
authors.affiliation: Central Laboratory of the Hospital (Maasstad Lab), Department of Clinical Chemistry, Maasstad Hospital, Rotterdam, The Netherlands. Koss@maasstadziekenhuis.nl
authors.forename: Snježana
authors.initials: S
authors.lastname: Kos
authors.forename: Arie
authors.initials: A
authors.lastname: van Meerkerk
authors.forename: Joke
authors.initials: J
authors.lastname: van der Linden
authors.forename: Theo
authors.initials: T
authors.lastname: Stiphout
authors.forename: Remi
authors.initials: R
authors.lastname: Wulkan
mesh_terms: D001774:Blood Chemical Analysis / Q000295:instrumentation* / Q000592:standards; D001786:Blood Glucose / Q000032:analysis*; D006400:Hematocrit; D006801:Humans; D010100:Oxygen / Q000737:chemistry; D019095:Point-of-Care Systems / Q000592:standards*; D011933:Reagent Kits, Diagnostic; D012016:Reference Values; D012044:Regression Analysis
chemical_list: D001786:Blood Glucose; D011933:Reagent Kits, Diagnostic; D010100:Oxygen