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Licensed Unlicensed Requires Authentication Published by De Gruyter March 28, 2014

System accuracy evaluation of systems for point-of-care testing of blood glucose: a comparison of a patient-use system with six professional-use systems

Guido Freckmann, Christina Schmid, Stefan Pleus, Annette Baumstark, Manuela Link, Erhard Stolberg, Cornelia Haug and Jochen Sieber

Abstract

Background: Point-of-care testing (POCT) of blood glucose (BG) is performed by medical personnel in clinical settings as well as by patients themselves for self-monitoring of blood glucose (SMBG) at home. We investigated if a system mainly intended for SMBG by people with diabetes, but also suitable for BG measurements by medical personnel, can achieve measurement accuracy on capillary blood samples comparable with professional-use POCT systems.

Methods: System accuracy was evaluated under standardised conditions, following the ISO standard 15197:2003. For each system (one SMBG system with three test strip lots and six professional-use systems), measurement results from capillary blood samples of 100 subjects were compared with a standardised laboratory glucose oxidase method (YSI 2300 glucose analyser).

Results: The seven evaluated systems showed 99.5% or 100% of the measurement results within the required system accuracy limits of ISO 15197:2003 (±0.83 mmol/L at BG concentrations <4.2 mmol/L and ±20% at BG concentrations ≥4.2 mmol/L). Applying the more stringent requirements of the revision ISO 15197:2013, the systems showed between 99% and 100% of the measurement results within the accuracy limits (±0.83 mmol/L at BG concentrations <5.55 mmol/L and ±15% at BG concentrations ≥5.55 mmol/L) and between 82% and 98% when even more restrictive limits were applied (±0.56 mmol/L and ±10%, respectively).

Conclusions: Data from this study, which focused on system accuracy, suggest that SMBG systems can achieve system accuracy that is comparable with professional-use systems when measurements are performed on capillary blood samples by trained personnel in a standardised and controlled setting.


Corresponding author: Stefan Pleus, Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Helmholtzstrasse 20, 89081 Ulm, Germany, Phone: +49 731/509900, E-mail:

Conflict of interest statement

Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article. Research funding played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

Research funding: This study was funded by a grant from Sanofi-Aventis Groupe, Antony, France.

Employment or leadership: GF is general manager of the IDT (Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany), which carries out studies evaluating BG meters and medical devices for diabetes therapy on behalf of various companies. CS, SP, AB, ML, ES, CH are employees of the IDT. JS is employee of Sanofi-Aventis Deutschland GmbH, Germany.

Honorarium: GF/IDT received speakers’ honoraria or consulting fees from Abbott, Bayer, Berlin-Chemie, Becton-Dickinson, Dexcom, Menarini Diagnostics, Roche Diagnostics, Sanofi, and Ypsomed. This study was funded by a grant from Sanofi-Aventis Groupe, Antony, France.

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Received: 2013-11-12
Accepted: 2014-3-5
Published Online: 2014-3-28
Published in Print: 2014-7-1

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