OBJECTIVE: To evaluate the performance of the StatStrip 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 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.
OBJECTIVE: To evaluate the performance of the StatStrip 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 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.
Authors: Kara A Lindquist; Kelsey Chow; Amy West; Laura Pyle; T Scott Isbell; Melanie Cree-Green; Kristen J Nadeau Journal: Diabetes Technol Ther Date: 2014-01-28 Impact factor: 6.118