Beurer GL44 lean
35
10 C
OMPARISON
OF
MEASURED
VALUES
WITH
LABORATORY
VALUES
Precision
Three lots of the GL44 lean blood glucose test strips have been tested to assess the precision of the
GL44 lean blood glucose monitoring system. This includes a repeat assessment using venous blood
and a laboratory precision assessment using the control material. The blood glucose content of the
venous blood samples ranges from 42.7 to 418.0
mg/dL (2.4 to 23.2
mmol/L) and control material
from three concentrations is used.
Results of the repeat precision measurements
Sample Venous blood
Grand mean value Pooled standard
deviation
Pooled coe
ffi
-
cient of variation
(%)
mg/dL
mmol/L mg/dL
mmol/L mg/dL
mmol/L
1
42.7
2.4
36.0
2.0
2.0
0.1
5.6
2
62.0
3.4
59.2
3.3
3.5
0.2
5.9
3
120.5
6.7
127.1
7.1
4.1
0.2
3.2
4
201.0
11.2
213.8
11.9
6.7
0.4
3.1
5
316.5
17.6
329.9
18.3
10.1
0.6
3.1
6
418.0
23.2
433.5
24.1
14.5
0.8
3.3
Results of the intermediate precision measurement
Sample Control material
Grand mean value Pooled standard
deviation
Pooled coe
ffi
cient
of variation (%)
mg/dL
mmol/L mg/dL
mmol/L mg/dL
mmol/L
1
70.0
3.9
71.3
4.0
1.0
0.1
1.4
2
135.6
7.5
136.3
7.6
1.4
0.1
1.1
3
351.5
19.5
350.8
19.5
2.8
0.2
0.8
System accuracy
The GL44 lean blood glucose monitor in comparison to the YSI.
Three lots of GL44 lean blood glucose test strips have been tested to assess the system accuracy
of the GL44 lean blood glucose monitoring system and to compare it with the reference method, in
which capillary whole blood concentrations of 36.0
mg/dL (2.0
mmol/L) to 442.5
mg/dL (24.6
mmol/L)
have been used.
