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.
Bundesärztekammer. Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen. Dt Ärzteblatt 2008;105:341–55.
Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;1:307–10.
Passing H, Bablok W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry, Part I. J Clin Chem Clin Biochem 1983;21:709–20.
Pfutzner A, Schipper C, Ramljak S, Flacke F, Sieber J, Forst T, et al. Determination of hematocrit interference in blood samples derived from patients with different blood glucose concentrations. J Diabetes Sci Technol 2013;7:170–8.
Ramljak S, Musholt PB, Schipper C, Flacke F, Sieber J, Borchert M, et al. The Precision study: examining the inter- and intra-assay variability of replicate measurements of BGStar, iBGStar and 12 other blood glucose monitors. Expert Opin Med Diagn 2013;7:511–6.
Twomey PJ. Plasma glucose measurement with the Yellow Springs Glucose 2300 STAT and the Olympus AU640. J Clin Pathol 2004;57:752–4.
Genter PM, Ipp E. Accuracy of plasma glucose measurements in the hypoglycemic range. Diabetes Care 1994;17:595–8.
Stork AD, Kemperman H, Erkelens DW, Veneman TF. Comparison of the accuracy of the HemoCue glucose analyzer with the Yellow Springs Instrument glucose oxidase analyzer, particularly in hypoglycemia. Eur J Endocrinol 2005;153:275–81.
Nowotny B, Nowotny PJ, Strassburger K, Roden M. Precision and accuracy of blood glucose measurements using three different instruments. Diabet Med 2012;29:260–5.
Robinson CS, Sharp P. Tighter accuracy standards within point-of-care blood glucose monitoring: how six commonly used systems compare. J Diabetes Sci Technol 2012;6:547–54.
Dungan K, Chapman J, Braithwaite SS, Buse J. Glucose measurement: confounding issues in setting targets for inpatient management. Diabetes Care 2007;30:403–9.
Heinemann L. Quality of glucose measurement with blood glucose meters at the point-of-care: relevance of interfering factors. Diabetes Technol Ther 2010;12:847–57.
Nerhus K, Rustad P, Sandberg S. Effect of ambient temperature on analytical performance of self-monitoring blood glucose systems. Diabetes Technol Ther 2011;13:883–92.
Oberg D, Ostenson CG. Performance of glucose dehydrogenase- and glucose oxidase-based blood glucose meters at high altitude and low temperature. Diabetes Care 2005;28:1261.
Pecchio O, Maule S, Migliardi M, Trento M, Veglio M. Effects of exposure at an altitude of 3,000 m on performance of glucose meters. Diabetes Care 2000;23:129–31.
Fink KS, Christensen DB, Ellsworth A. Effect of high altitude on blood glucose meter performance. Diabetes Technol Ther 2002;4:627–35.
Warner JV, Wu JY, Buckingham N, McLeod DS, Mottram B, Carter AC. Can one point-of-care glucose meter be used for all pediatric and adult hospital patients? Evaluation of three meters, including recently modified test strips. Diabetes Technol Ther 2011;13:55–62.
Lyon ME, Baskin LB, Braakman S, Presti S, Dubois J, Shirey T. Interference studies with two hospital-grade and two home-grade glucose meters. Diabetes Technol Ther 2009;11:641–7.
Critchell CD, Savarese V, Callahan A, Aboud C, Jabbour S, Marik P. Accuracy of bedside capillary blood glucose measurements in critically ill patients. Intensive Care Med 2007;33:2079–84.
Louie RF, Tang Z, Sutton DV, Lee JH, Kost GJ. Point-of-care glucose testing: effects of critical care variables, influence of reference instruments, and a modular glucose meter design. Arch Pathol Lab Med 2000;124:257–66.
Atkin SH, Dasmahapatra A, Jaker MA, Chorost MI, Reddy S. Fingerstick glucose determination in shock. Ann Intern Med 1991;114:1020–4.
Tanvetyanon T, Walkenstein MD, Marra A. Inaccurate glucose determination by fingerstick in a patient with peripheral arterial disease. Ann Intern Med 2002;137:W1.
Sacks DB, Arnold M, Bakris GL, Bruns DE, Horvath AR, Kirkman MS, et al. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem 2011;57:e1–47.
Kerner W, Brückel J. Definition, klassifikation und diagnostik des diabetes mellitus. Diabetol Stoffwechs 2012;7:S84–7.
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:
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