Evaluation of a point-of-care glucose meter 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.


CONCLUSIONS
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.
Department of Clinical Pathology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada M4N 3M5. pc.chan@sunnybrook.ca
Pak Cheung R
PC
Chan
Mary
M
Rozmanc
Isolde
I
Seiden-Long
Jason
J
Kwan
D001786:Blood Glucose / Q000032:analysis*; D006268:Health Facilities; D006801:Humans; D019095:Point-of-Care Systems; D011934:Reagent Strips; D015203:Reproducibility of Results
D001786:Blood Glucose; D011934:Reagent Strips