title: Performance of strip-based glucose meters and cassette-based blood gas analyzer for monitoring glucose levels in a surgical intensive care setting.
abstract: BACKGROUND
  We verified the analytical performance of strip-based handheld glucose meters (GM) for prescription use, in a comparative split-sample protocol using blood gas samples from a surgical intensive care unit (ICU).
  
  
  METHODS
  Freestyle Precision Pro (Abbott), StatStrip Connectivity Meter (Nova), ACCU-CHEK Inform II (Roche) were evaluated for recovery/linearity, imprecision/repeatability. The GMs and the ABL90 (Radiometer) blood gas analyzer (BGA) were tested for relative accuracy vs. the comparator hexokinase glucose-6-phosphate-dehydrogenase (HK/G6PDH) assay on a Cobas c702 analyzer (Roche).
  
  
  RESULTS
  Recovery of spiked glucose was linear up to 19.3 mmol/L (347 mg/dL) with a slope of 0.91-0.94 for all GMs. Repeatability estimated by pooling duplicate measurements on samples below (n=9), in (n=51) or above (n=80) the 4.2-5.9 mM (74-106 mg/dL) range were for Freestyle Precision Pro: 4.2%, 4.0%, 3.6%; StatStrip Connectivity Meter: 4.0%, 4.3%, 4.5%; and ACCU-CHEK Inform II: 1.4%, 2.5%, 3.5%. GMs were in agreement with the comparator method. The BGA outperformed the GMs, with a MARD of 3.9% compared to 6.5%, 5.8% and 4.4% for the FreeStyle, StatStrip and ACCU-CHEK, respectively. Zero % of the BGA results deviated more than the FDA 10% criterion as compared to 9.4%, 3.7% and 2.2% for the FreeStyle, StatStrip and ACCU-CHEK, respectively. For all GMs, icodextrin did not interfere. Variation in the putative influence factors hematocrit and O2 tension could not explain observed differences with the comparator method.
  
  
  CONCLUSIONS
  GMs quantified blood glucose in whole blood at about the 10% total error criterion, proposed by the FDA for prescription use.
authors.forename: Helena
authors.initials: H
authors.lastname: Claerhout
authors.forename: Martine
authors.initials: M
authors.lastname: De Prins
authors.forename: Dieter
authors.initials: D
authors.lastname: Mesotten
authors.forename: Greet
authors.initials: G
authors.lastname: Van den Berghe
authors.forename: Chantal
authors.initials: C
authors.lastname: Mathieu
authors.forename: Johan
authors.initials: J
authors.lastname: Van Eldere
authors.forename: Florent
authors.initials: F
authors.lastname: Vanstapel
mesh_terms: D001784:Blood Gas Analysis / Q000295:instrumentation / Q000379:methods*; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation / Q000379:methods*; D003422:Critical Care; D006801:Humans; D012680:Sensitivity and Specificity
chemical_list: D001786:Blood Glucose