System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197

Abstract

Background: Blood glucose (BG) monitoring systems enable diabetes patients to effectively control and adjust their therapy. BG monitoring systems with a Conformité Européenne (CE) label should meet the standard DIN EN ISO 15197:2003: > or =95% of the BG results shall fall within +/-15 mg/dL of the reference method at BG concentrations <75 mg/dL and within +/-20% at BG concentrations > or =75 mg/dL. We intended to verify if BG monitoring systems with a CE label fulfill these minimum accuracy requirements.

Methods: We evaluated 27 BG monitoring systems from 18 manufacturers for system accuracy according to DIN EN ISO 15197:2003. Twenty-four systems were compared with the glucose oxidase reaction (YSI 2300 glucose analyzer [YSI Life Sciences, Yellow Springs, OH]) and three systems with the hexokinase reaction (Hitachi 917 [Roche Diagnostics GmbH, Mannheim, Germany]). Duplicate measurements of 100 blood samples with a defined distribution of BG concentrations from 20 mg/dL to 600 mg/dL from > or =100 subjects were included in the evaluation.

Results: Sixteen of the 27 BG monitoring systems fulfilled the minimum accuracy requirements of the standard, i.e., > or =95% of their results showed the minimum acceptable accuracy. Overall, the mean percentage of results showing the minimum acceptable accuracy was 95.2 +/- 5.2%, ranging from 80.0% to 100.0%.

Conclusions: More than 40% of the evaluated BG monitoring systems did not fulfill the minimum accuracy requirements of DIN EN ISO 15197:2003. As inaccurate BG monitoring systems bear the risk of false treatment decisions by the diabetes patient and subsequent possible severe health injury, manufacturers should regularly and effectively check the quality of BG meters and BG test strips.