Klinisk Biokemi i Norden · 2 2018
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Conclusion
The quality goals set for Accu-Chek Guide were fulfil-
led for both repeatability and accuracy under optimal
conditions by experienced laboratory personnel as
well as under real-life conditions by intended users
Figure 2.
Accuracy of glucose results on Accu-Chek Guide under optimal conditions. The x-axis represents the mean glucose
result of the comparison method. The y-axis represents the glucose deviation in mmol/L of the first measurement on Accu-
Chek Guide from the mean result of the corresponding sample of the comparison method. The different lots of test strips are
illustrated as lot A (●), lot B (♦) and lot C (x). Stippled lines represent the quality goal limits set in ISO 15197:2013 (within
±0,83 mmol/L of the results
of the comparison method
for glucose concentrations
<5,55 mmol/L and within
±15 % for glucose concen-
trations ≥5,55 mmol/L).
Number of results (n) = 89
Figure 3.
Accuracy of glucose results on Accu-Chek Guide achieved by the intended users (three lots of test strips). The
x-axis represents the mean glucose result of the comparison method. The y-axis represents the glucose deviation in mmol/L
of the first measurement on Accu-Chek Guide from the mean result of the corresponding sample of the comparison method.
Stippled lines represent the quality goal limits set in ISO 15197:2013 (within ±0,83 mmol/L of the results of the comparison
method for glucose con-
centrations <5,55 mmol/L
and within ±15 % for glu-
cose concentrations ≥5,55
mmol/L). Number of results
(n) = 88. Statistical outliers
from the calculations of
repeatability are illustrated
with a circle around the
symbol.
-6
-4
-2
0
2
4
6
0
5
10
15
20
25
Deviation, Accu-Chek Guide, mmol/L
Glucose, the comparison method, mmol/L
Meter A/lot a
Meter B/lot b
Meter C/lot c
+15 %
-15 %
Deviation for:
-6
-4
-2
0
2
4
6
0
5
10
15
20
25
Deviation, Accu-Chek Guide, mmol/L
Glucose, the comparison method, mmol/L
Meter A/lot a
Meter B/lot b
Meter C/lot c
+15 %
-15 %
Deviation for:
-6
-4
-2
0
2
4
6
0
5
10
15
20
25
Deviation Accu-Chek Guide, mmol/L
Glucose, the comparison method, mmol/L
+15 %
-15 %
(people with diabetes). The quality goal for user-
friendliness was also fulfilled.
The complete evaluation report is available at
www.
skup.org
. Roche Diabetes Care Norge AS accepted the
report without further comments.
