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. 2015 Mar;9(2):262-7.
doi: 10.1177/1932296814565790. Epub 2014 Dec 30.

Evaluation of hematocrit interference with MyStar extra and seven competitive devices

Filiz Demircik  1 , Sanja Ramljak  2 , Iris Hermanns  3 , Anke Pfützner  2 , Andreas Pfützner  4
Affiliations

Evaluation of hematocrit interference with MyStar extra and seven competitive devices

Filiz Demircik et al. J Diabetes Sci Technol. 2015 Mar.

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.

Keywords: accuracy; blood glucose meter; dynamic electrochemistry; hematocrit interference.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: AP received research grants, travel support, and consultancy fees from Sanofi.

Figures

Figure 1.
Figure 1.
Results of the hematocrit interference test protocol with MyStar Extra.
Figure 2.
Figure 2.
Results of the hematocrit interference test protocol with Contour XT, Contour Link, FreeStyle Freedom Lite, and MyLife Pura.
Figure 3.
Figure 3.
Results of the hematocrit interference test protocol with Accu-Chek Aviva Nano, Accu-Chek Performa, and OneTouch Verio Pro.
Figure 4.
Figure 4.
Hematocrit interference factor of all tested devices for benchmark comparison of hematocrit interference.
See this image and copyright information in PMC

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