Technical information, Precision, Glucometer e – Bayer Esprit User Manual
Page 24: System, Patient use clinical study results
CHAPTER
Technical Information
15
39
Glucometer E
SPRIT
Results
Within-run
Total
Mean
S D
C V
S D
C V
Control
mg/dL (mmol/L)
mg/dL (mmol/L)
(%)
mg/dL (mmol/L)
(%)
Low
69
(3.83)
2.7 (0.15)
3.9
3.5 (0.19)
5.1
Normal
127
(7.05)
4.7 (0.26)
3.7
5.7 (0.32)
4.5
High
372 (20.64)
5.7 (0.32)
1.5
7.1 (0.34)
1.9
YSI
Glucometer E
SPRIT
Results
Mean Whole
Blood Glucose
No. of
Mean
S D
C V
mg/dL (mmol/L)
Tests
mg/dL (mmol/L)
Bias
mg/dL (mmol/L) (%)
21
(1.17)
78
19
(1.05)
–2 mg/dL or
2.6 (0.14)
13.8
–0.11 mmol/L
49
(2.72)
78
48
(2.66)
– 1.8%
3.2 (0.18)
6.7
102
(5.66)
80
103
(5.72)
–
0.9%
3.7 (0.21)
3.6
192 (10.65)
79
192 (10.65)
–
0.0%
6.4 (0.36)
3.3
376 (20.87)
80
382 (21.20)
–
1.6%
10.2 (0.57)
2.7
566 (31.41)
80
593 (32.91)
–
4.8%
16.2 (0.90)
2.7
2. Precision:
Precision Results for Whole Blood Specimens: EDTA
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
Glucometer E
SPRIT
meters and one lot of sensors. The whole blood
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 procedure (HEW publication no. [CDC] 77-8330).
Precision Results for Controls: The Glucometer E
SPRIT
Control solu-
tions were tested in triplicate twice per day for ten days by one opera-
tor using one meter and one lot of sensors. The following precision
results were obtained:
Glucometer E
SPRIT
System
(Whole Blood Referenced)
38
CHAPTER
15
Technical Information
Figure 1
Glucometer E
SPRIT
System Results
Obtained By 61
Lay Diabetics.
Figure 2
Glucometer E
SPRIT
System Results
Obtained By 6
Healthcare
Professionals.
Patient Use Clinical Study Results