Bayer HealthCare Ascensia DEX2 User Manual page 45

Technical information
2. Precision:
Precision Results for Whole Blood Specimens:
Heparin anticoagulated glycolyzed whole blood pools were
supplemented with glucose to obtain five glucose levels.
Multiple replicates of the whole blood were tested on one
day by multiple operators using multiple Ascensia D
meters and one lot of test strips. The plasma glucose levels
of the blood specimens were also tested using the YSI 2300
Stat Plus Glucose Analyzer, a glucose oxidase method. The
accuracy of the YSI was verified using control sera assayed
using a modification of the CDC hexokinase reference proce-
dure [HEW publication no.(CDC)77-8330].
YSI
Mean
Plasma
No. of
Glucose
Tests
(mg/dL)
25
78
56
78
115
80
216
79
429
80
Precision Results for Controls:
The Ascensia A
multiple days by one operator using one meter and one lot
of test strips. The following precision results were obtained:
No. of
Control
Runs
Low 20
Normal 20
20
High
Ascensia D
Bias
Mean
(mg/dL) (mg/dL)
- 4.1
21
54 - 1.8
116 0.9
- 0.2
216
430 1.4
Control solutions were tested on
UTODISC
Ascensia D
No. of Mean
Tests (mg/dL)
60 69
60 127
60 372
2 Results
EX
S D
Bias
(%) (mg/dL)
2.9
-16.3
-3.3 3.6
0.7 4.1
7.2
-0.1
0.3 11.5
2 Results
EX
Within-run
S D C V
(mg/dL) (%) (mg/dL)
2.7 3.9
4.7 3.7
5.7 1.5
38
2
EX
C V
(%)
13.8
6.7
3.6
3.3
2.7
Total
S D C V
(%)
3.5 5.1
5.7 4.5
7.1 1.9