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Accuracy
1. Bayer Accuracy Evaluation:
To assess the accuracy of the Ascensia™ CONTOUR™ System,
60 fresh fingerstick specimens from people with diabetes
were tested with the Ascensia C
ONTOUR System (12 – 14
readings per fingerstick) and the YSI 2300 STAT Plus Glucose
Analyzer. The glucose concentration of the samples ranged
from 2.5 to 25.2 mmol/L with an average of 8.4 mmol/L. The
range of hematocrits was 32% to 49% with an average of
40%.
High Control Solution
Duplicate Overall Overall
Reagent Assays Mean SD CV
Lot Operator (n = ) (mmol/L) (mmol/L) (%)
22B HCP (n = 1) 35 18.72 0.737 3.9
Lay User (n = 51) 76 18.96 0.829 4.4
22C HCP (n = 4) 39 19.53 0.498 2.6
Lay User (n = 53) 78 19.49 0.619 3.2
23B HCP (n = 5) 74 19.18 0.578 3.0
Lay User (n = 104) 154 18.03 0.524 2.9
Normal Control Solution
Duplicate Overall Overall
Reagent Assays Mean SD CV
Lot Operator (n = ) (mmol/L) (mmol/L) (%)
22B HCP (n = 1) 35 6.64 0.254 3.8
Lay User (n = 51) 76 6.69 0.216 3.2
22C HCP (n = 4) 39 6.77 0.179 2.6
Lay User (n = 53) 78 6.79 0.271 4.0
23B HCP (n = 5) 74 6.71 0.169 2.5
Lay User (n = 104) 154 6.67 0.204 3.1