title: Evaluation of hematocrit interference with MyStar extra and seven competitive devices.
abstract: In previous studies, meters employing dynamic electrochemistry (DE), have been shown to correct for hematocrit (HCT) interference. This laboratory investigation assessed the HCT stability of MyStar Extra (Sanofi) in comparison to 7 competitive devices (Accu-Chek Aviva Nano & Accu-Chek Performa, Roche Diagnostics; Contour XT and Contour Link, Bayer; FreeStyle Freedom Lite, Abbott; MyLife Pura, Ypsomed; OneTouch Verio Pro, LifeScan). Venous heparinized blood was freshly drawn, immediately aliquoted, and manipulated to contain 3 different blood glucose concentrations (50-80 mg/dL, 150-180 mg/dL, and 350-400 mg/dL) and 5 different HCT levels (20-25%, 30-35%, 40-45%, 50-55%, and 60-65%). After careful oxygenation to normal blood oxygen pressure, each of the 15 different samples was measured 8 times with 2 devices and 2 strip lots of each meter (32 measurements/meter/sample). YSI Stat 2300 served as laboratory reference method. Next to determination of the mean absolute relative deviation (MARD), stability to HCT influence was assumed, when less than 10% difference occurred between the highest and lowest mean glucose deviations in relation to HCT over all tested glucose ranges (HIF: hematocrit interference factor). Four of the devices showed stable performance: Contour XT (MARD: 1.3%/HIF: 6.1%), MyStar Extra (4.7%/7.1%), OneTouch Verio Pro (4.5%/7.3%), and Contour Link (6.3%/9.3%). The 4 other meters were influenced by HCT (Accu-Chek Performa: 4.7%/20.9%, Accu-Chek Aviva Nano: 4.5%/22.4%, FreeStyle Freedom Lite: 4.8%/24.5%; MyLife Pura: 6.4%/28.7%). In this study, all meters showed a good accuracy, but only 50% of them, including MyStar Extra, were shown to reliably correct for potential hematocrit influence on the meter results.
authors.affiliation: Pfützner Science & Health Institute, Mainz, Germany Sciema-Science & Marketing UG, Mainz, Germany.
authors.forename: Filiz
authors.initials: F
authors.lastname: Demircik
authors.affiliation: Sciema-Science & Marketing UG, Mainz, Germany.
authors.forename: Sanja
authors.initials: S
authors.lastname: Ramljak
authors.affiliation: University Hospital, Center of Thrombosis and Hemostasis, Mainz, Germany.
authors.forename: Iris
authors.initials: I
authors.lastname: Hermanns
authors.affiliation: Sciema-Science & Marketing UG, Mainz, Germany.
authors.forename: Anke
authors.initials: A
authors.lastname: Pfützner
authors.affiliation: Pfützner Science & Health Institute, Mainz, Germany Sciema-Science & Marketing UG, Mainz, Germany andreas.pfuetzner@pfuetzner-mainz.com.
authors.forename: Andreas
authors.initials: A
authors.lastname: Pfützner
mesh_terms: D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D004563:Electrochemistry / Q000295:instrumentation*; D006400:Hematocrit; D006801:Humans
chemical_list: D001786:Blood Glucose
keywords: accuracy; blood glucose meter; dynamic electrochemistry; hematocrit interference