title: Fundamental Importance of Reference Glucose Analyzer Accuracy for Evaluating the Performance of Blood Glucose Monitoring Systems (BGMSs).
abstract: As blood glucose monitoring system (BGMS) accuracy is based on comparison of BGMS and laboratory reference glucose analyzer results, reference instrument accuracy is important to discriminate small differences between BGMS and reference glucose analyzer results. Here, we demonstrate the important role of reference glucose analyzer accuracy in BGMS accuracy evaluations.
  
  
  
  Two clinical studies assessed the performance of a new BGMS, using different reference instrument procedures. BGMS and YSI analyzer results were compared for fingertip blood that was obtained by untrained subjects' self-testing and study staff testing, respectively. YSI analyzer accuracy was monitored using traceable serum controls.
  
  
  
  In study 1 (N = 136), 94.1% of BGMS results were within International Organization for Standardization (ISO) 15197:2013 accuracy criteria; YSI analyzer serum control results showed a negative bias (-0.64% to -2.48%) at the first site and a positive bias (3.36% to 6.91%) at the other site. In study 2 (N = 329), 97.8% of BGMS results were within accuracy criteria; serum controls showed minimal bias (<0.92%) at both sites.
  
  
  
  These findings suggest that the ability to demonstrate that a BGMS meets accuracy guidelines is influenced by reference instrument accuracy.
authors.affiliation: AMCR Institute Inc, Escondido, CA, USA tbailey@amcrinstitute.com.
authors.forename: Timothy S
authors.initials: TS
authors.lastname: Bailey
authors.affiliation: Rainier Clinical Research Center, Renton, WA, USA.
authors.forename: Leslie J
authors.initials: LJ
authors.lastname: Klaff
authors.affiliation: Ascensia Diabetes Care, Parsippany, NJ, USA.
authors.forename: Jane F
authors.initials: JF
authors.lastname: Wallace
authors.affiliation: Ascensia Diabetes Care, Parsippany, NJ, USA.
authors.forename: Carmine
authors.initials: C
authors.lastname: Greene
authors.affiliation: Ascensia Diabetes Care, Parsippany, NJ, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Pardo
authors.affiliation: Ascensia Diabetes Care, Parsippany, NJ, USA.
authors.forename: Bern
authors.initials: B
authors.lastname: Harrison
authors.affiliation: Ascensia Diabetes Care, Parsippany, NJ, USA.
authors.forename: David A
authors.initials: DA
authors.lastname: Simmons
mesh_terms: D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation / Q000592:standards*; D003920:Diabetes Mellitus / Q000097:blood*; D006801:Humans; D012016:Reference Values
chemical_list: D001786:Blood Glucose
keywords: ISO 15197:2013; YSI; accuracy; blood glucose monitoring system; reference glucose analyzer; reference instrument