User guide

24
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 45 to
454 mg/dL with an average of 150 mg/dL. 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 = ) (mg/dL) (mg/dL) (%)
22B HCP (n = 1) 35 337.2 13.28 3.9
Lay User (n = 51) 76 341.5 14.94 4.4
22C HCP (n = 4) 39 351.9 8.98 2.6
Lay User (n = 53) 78 351.2 11.16 3.2
23B HCP (n = 5) 74 345.6 10.41 3.0
Lay User (n = 104) 154 324.8 9.44 2.8
Normal Control Solution
Duplicate Overall Overall
Reagent Assays Mean SD CV
Lot Operator (n = ) (mg/dL) (mg/dL) (%)
22B HCP (n = 1) 35 119.6 4.58 3.8
Lay User (n = 51) 76 120.6 3.90 3.2
22C HCP (n = 4) 39 122.0 3.23 2.6
Lay User (n = 53) 78 122.3 4.88 4.0
23B HCP (n = 5) 74 120.9 3.04 2.5
Lay User (n = 104) 154 120.1 3.67 3.1