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39
| 2 | 2008
Klinisk Biokemi i Norden
dardised and optimal measuring conditions and
between 3 and 5 % when the measurements were
performed by the diabetes patients.
The agreement with a designated comparison met-
hod was good. The quality goal set in ISO 15197 was
achieved under standardised and optimal measuring
conditions. When handled by the diabetes patients,
Ascensia Breeze2 also showed accurate results.
These results were within an “adjusted ISO-goal” (TE
within ±25 %) and also within the quality goal set in
ISO 15197 (Fig. 1).
The three lots of test strips used in this evaluation
all gave glucose results in agreement with the compa-
rison method. No significant difference was pointed
out.
Glucose measurements on Ascensia Breeze2 see-
med to be affected by hematocrit. The range of
hematocrit-values in the samples was 33 – 50 %.
The diabetes patients summarised the Ascensia
Breeze2 device as easy to use. Most of them were
pleased with the device. The diabetes patients that
had used the user guide were satisfied with the
guide.
Results, FreeStyle
Lite
The precision of FreeStyle
Lite
was good. The repeata-
bility CV was between 2 and 3 % under standardised
and optimal measuring conditions and approximately
4 % when the measurements were performed by the
diabetes patients.
The agreement with a designated comparison met-
hod was good. The quality goals set in ISO 15197 was
achieved under standardised and optimal measuring
conditions. When handled by the diabetes patients,
FreeStyle
Lite
also showed accurate results. These
results were within the “adjusted ISO-goal” and also
within the quality goal set in ISO 15197 (Fig. 2).
Two of the three lots of test strips used in this
evaluation gave lower values than the comparison
method. The third lot of test strips gave higher values
than the comparison method. The deviations were
small, but statistically significant.
Glucose measurements on FreeStyle
Lite
did not
seem to be affected by hematocrit. The range of
hematocrit-values in the samples was 31 – 48 %.
The diabetes patients summarised the FreeStyle
Lite
device as easy to use. Most of them were pleased
with the device. Most of the diabetes patients that had
used the user guide were satisfied with the guide.
Conclusion
The precision of Ascensia Breeze2 and FreeStyle
Lite
was good. The accuracy was also good and the results
were within the quality goal set in ISO 15197. Glucose
measurements on Ascensia Breeze2 seemed to be
affected by hematocrit, while the glucose measure-
ments on FreeStyle Lite did not seem to be affected
by hematocrit. The users found the devices easy to
use and were quite satisfied with the devices and the
user guides.
The complete evaluation reports are available at www.
skup.nu
Figure 1. Accuracy. The diabetes patients’ self-measurements
at the final consultation. Three lots of test strips. The x-axis
represents the mean value of the duplicate results on the com-
parison method. The y-axis shows the difference between the
first measurement on Ascensia Breeze2 and the mean value
of the duplicate results on the comparison method, n = 75.
Figure 2. Accuracy. The diabetes patients’ self-measurements
at the final consultation. Three lots of test strips. The x-axis
represents the mean value of the duplicate results on the com-
parison method. The y-axis shows the difference between the
first measurement on FreeStyle Lite and the mean value of the
duplicate results on the comparison method, n = 76.
