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Objective: To evaluate the analytical performance and clinical accuracy of the FreeStyle ® Lite Blood
BibTeX
@MISC{System_objective:to,
author = {Glucose Monitoring System},
title = {Objective: To evaluate the analytical performance and clinical accuracy of the FreeStyle ® Lite Blood},
year = {}
}
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Abstract
Method: Clinical accuracy for fingertip capillary blood testing was assessed at three diabetes clinics with three lots of FreeStyle Lite test strips. At the same clinics, lay user performance and alternative site testing (on forearm, upper arm, palm thenar, palm hypothenar, back of the hand, calf and thigh) were also evaluated. FreeStyle Lite system results in these studies were compared to the plasma equivalent glucose values of the fingertip blood samples measured by the YSI Glucose An-alyzer. Subjects participating in the user performance study rated the ease of use of the FreeStyle Lite system. Laboratory studies were performed at Abbott Diabetes Care to validate analytical performance of the FreeStyle Lite system under various testing conditions. Results: In fingertip testing, accuracy of the FreeStyle Lite system was demonstrated by com-paring results from 142 patients with the YSI plasma equivalent glucose values (r = 0.99, mean absolute bias = 4.7 %). We found 99.3 % of the individual FreeStyle Lite system results within the ISO accuracy limits. ISO 15197 specifies that 95 % of the individual meter results shall fall within ± 15 mg/dL ( ± 0.83 mmol/L) of the reference measurement procedure at glucose concentrations < 75 mg/dL (< 4.2 mmol/L) and within ± 20 % at glucose concentrations ≥ 75 mg/dL ( ≥ 4.2 mmol/L). Using more stringent criteria than ISO 15197, we found that 98.6%, 92.3 % and 69.7 % of the individual
Keyphrases
clinical accuracy analytical performance freestyle lite system mg dl freestyle lite blood glucose concentration user performance study alternative site ysi plasma equivalent glucose value freestyle lite system result plasma equivalent glucose value freestyle lite test strip reference measurement procedure absolute bias com-paring result diabetes clinic palm hypothenar abbott diabetes care user performance laboratory study palm thenar fingertip testing ysi glucose an-alyzer individual meter result individual freestyle lite system result upper arm stringent criterion iso accuracy limit fingertip blood sample fingertip capillary blood testing
