Evaluation of a point-of-care glucose meter for general use in complex tertiary care facilities

Objective: To evaluate the performance of the StatStrip (TM) glucose meter from Nova Biomedical for use in complex tertiary care facilities. Methods: Performance evaluation was conducted in 6 clinical locations involving nurse end-users. Imprecision (CV)<5% was considered acceptable. Ten substances were examined for potential analytical interferences at two levels and 3 glucose concentrations. Inaccuracy was determined by 386 paired glucose differences between glucose meter and laboratory reference analyses. Acceptability was based on CSLI/ISO15197 criteria. Potential clinical impact was classified under a 5-level severity scheme. Results: Imprecision varied from CV 2.4 to 4.9%. Significant interference was observed only for free hemoglobin at 10 g/L. 97% of paired glucose meter-laboratory differences met CSLI/ISO15197 criteria. All discrepant results had low severity scores. Conclusion: The StatStripT (TM) glucose meter demonstrated acceptable imprecision and inaccuracy, and was relatively free from common interferences. It should be a good candidate for general use in complex tertiary care facilities. (C) 2009 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.