Accuracy - Bayer HealthCare Ascensia Contour Blood Glucose Monitoring System User Manual

Normal Control Solution
Reagent
Lot
22B HCP
Lay User
22C HCP
Lay User
23B HCP
Lay User
High Control Solution
Reagent
Lot
22B HCP
Lay User
22C HCP
Lay User
23B HCP
Lay User

Accuracy

1. Bayer Accuracy Evaluation:
To assess the accuracy of the Ascensia™ C
60 fresh fingerstick specimens from people with diabetes
were tested with the Ascensia C
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%.
24
Operator
(n = 1)
(n = 51)
(n = 4)
(n = 53)
(n = 5)
(n = 104)
Operator
(n = 1)
(n = 51)
(n = 4)
(n = 53)
(n = 5)
(n = 104)
Duplicate
Assays Mean
(n = ) (mmol/L)
35 6.64
76 6.69
39 6.77
78 6.79
74 6.71
154 6.67
Duplicate
Assays Mean
(n = ) (mmol/L)
35 18.72
76 18.96
39 19.53
78 19.49
74 19.18
154 18.03
System (12 – 14
ONTOUR
Overall
SD
(mmol/L)
0.254
0.216
0.179
0.271
0.169
0.204
Overall
SD
(mmol/L)
0.737
0.829
0.498
0.619
0.578
0.524
™ System,
ONTOUR
Overall
CV
(%)
3.8
3.2
2.6
4.0
2.5
3.1
Overall
CV
(%)
3.9
4.4
2.6
3.2
3.0
2.9