Article ID Journal Published Year Pages File Type
1971017 Clinical Biochemistry 2009 9 Pages PDF
Abstract

ObjectiveTo evaluate the performance of the StatStrip™ glucose meter from Nova Biomedical for use in complex tertiary care facilities.MethodsPerformance 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.ResultsImprecision 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.ConclusionThe StatStrip™ 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.

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