title: Blood glucose meters employing dynamic electrochemistry are stable against hematocrit interference in a laboratory setting.
abstract: BACKGROUND
  Hematocrit (HCT) is known to be a confounding factor that interferes with many blood glucose (BG) measurement technologies, resulting in wrong readings. Dynamic electrochemistry has been identified as one possible way to correct for these potential deviations. The purpose of this laboratory investigation was to assess the HCT stability of four BG meters known to employ dynamic electrochemistry (BGStar and iBGStar, Sanofi; Wavesense Jazz, AgaMatrix; Wellion Linus, MedTrust) in comparison with three other devices (GlucoDock, Medisana; OneTouch Verio Pro, LifeScan; FreeStyle Freedom InsuLinx, Abbott-Medisense).
  
  
  METHODS
  Venous heparinized blood was immediately aliquoted after draw and manipulated to contain three different BG concentrations (60-90, 130-160, and 280-320 mg/dl) and five different HCT levels (25%, 35%, 45%, 55%, and 60%). After careful oxygenation to normal blood oxygen pressure, each of the resulting 15 different samples was measured six times with three devices and three strip lots of each meter. The YSI Stat 2300 served as laboratory reference method. Stability to HCT influence was assumed when less than 10% difference occurred between the highest and lowest mean glucose deviations in relation to HCT concentrations [hematocrit interference factor (HIF)].
  
  
  RESULTS
  Five of the investigated self-test meters showed a stable performance with the different HCT levels tested in this investigation: BGStar (HIF 4.6%), iBGStar (6.6%), Wavesense Jazz (4.1%), Wellion Linus (8.5%), and OneTouch Verio Pro (6.2%). The two other meters were influenced by HCT (FreeStyle InsuLinx 17.8%; GlucoDock 46.5%).
  
  
  CONCLUSIONS
  In this study, meters employing dynamic electrochemistry, as used in the BGStar and iBGStar devices, were shown to correct for potential HCT influence on the meter results. Dynamic electrochemistry appears to be an effective way to handle this interfering condition.
authors.affiliation: IKFE Services-Institute for Clinical Research and Development, D-55116 Mainz, Germany. andreasp@ikfe.de.
authors.forename: Andreas
authors.initials: A
authors.lastname: Pfützner
authors.forename: Petra B
authors.initials: PB
authors.lastname: Musholt
authors.forename: Christina
authors.initials: C
authors.lastname: Schipper
authors.forename: Filiz
authors.initials: F
authors.lastname: Demircik
authors.forename: Carina
authors.initials: C
authors.lastname: Hengesbach
authors.forename: Frank
authors.initials: F
authors.lastname: Flacke
authors.forename: Jochen
authors.initials: J
authors.lastname: Sieber
authors.forename: Thomas
authors.initials: T
authors.lastname: Forst
mesh_terms: D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000379:methods; D003920:Diabetes Mellitus / Q000097:blood; D055664:Electrochemical Techniques / Q000295:instrumentation* / Q000379:methods; D006400:Hematocrit / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D007753:Laboratories; D015203:Reproducibility of Results
chemical_list: D001786:Blood Glucose