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Validation of five point-of-care glucometers

Self-monitoring of blood glucose is a convenient way in the management of patients with type 2 diabetes mellitus (T2DM). Although numerous glucometers are available in the market, only rare can achieve requested performance characteristics given by International Federation in Clinical Chemistry and Laboratory Medicine (IFCC) and, especially, American Diabetes Association (ADA). ADA sets analytical error at <5% while IFCC allowable error is <20%. The aim of the study was to investigate analytical performance characteristics of five glucometers versus reference laboratory method. Glucometers of five different manufacturers [Conture (Bayer Vital GmbH, Leverkusen, Germany), Xceed (Abbott Diabetes Care Inc., Almeda, CA, USA), AccuCheck Active (Roche Diagnostics, Mannheim, Germany), Bionime GM550 (Bionime GmbH, Switzerland) and X- meter (Glucocard, Arkray Factory Inc, Shiga, Japan)] were validated. Laboratory glucose was measured with the IFCC reference method with the hexokinase on AU 2700 (Beckman Coulter, Brea, CA, USA). Venous blood was drawn from 30 T2DM patients and healthy volunteers in sodium fluoride/potassium oxalate vacutainers (Greiner Bio-One, Kramsmünster, Austria). Immediately after venous blood sampling, capillary blood glucose was determined on all glucometers for each patient. All glucometers have shown satisfactory imprecision (Conture 5% ; AccuCheck 4.2% ; Xceed 5.1% ; X-meter 5.2%, Bionime 3.3%). Relative mean biases between glucometer and reference method were: Conture (4.02%), Bionime GM550 (14.31%), AccuCheck Active (3.16%), Xceed (6.08%), X-meter (12.46%). Passing-Bablok regression analysis have shown systematic shift for AccuCheck Active (y=-0, 2906 [-0.6162 – (-0.1500)]+1, 0156 (1, 0000 - 1, 0541))x and proportional difference for Bionime GM550 (y=0, 06113 (-0, 3079 - 0, 5261) + 0, 8473 (0.7826 – 0.8947))x. Error grid analysis showed 100 % results in A zone for all glucometers except Bionime with only 4 % results in A zone. Results of the study showed that glucometers Conture and Xceed satisfy analytical performance according to IFCC recommendations while only Conture fulfil ADA criteria.

point of care testing; glucometers

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