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40
| 3 | 2006
Klinisk Biokemi i Norden
41
| 3 | 2006
Klinisk Biokemi i Norden
Figure 2. Accuracy. The diabetics’
self-measurements at the final
consultation. Three lots of test
strips.
The x-axis represents the mean
value of the duplicate results at
the comparison method. The y-
axis shows the difference between
the first measurement at Accu-
Chek Aviva and the mean value
of the duplicate results at the
comparison method, n = 77. The
outlier with the negative bias is
probably due to problems with
the comparison method.
Figure 1. Accuracy. The diabetics’
self-measurements at the final
consultation. Two lots of test
strips.
The x-axis represents the mean
value of the duplicate results at
the comparison method. The y-
axis shows the difference between
the first measurement at Compact
Plus and the mean value of the
duplicate results at the compari-
son method. n = 75.
Figure 3. Accuracy. The diabetics’
self-measurements at the final
consultation. Three lots of test
strips.
The x-axis represents the mean
value of the duplicate results at
the comparison method. The y-
axis shows the difference between
the first measurement at Accu-
Chek Sensor and the mean value
of the duplicate results at the
comparison method, n = 77.
Background
In order to give reimbursement for glucose test
strips in Norway, The National Social Insurance
Office (Rikstrygdeverket) instructs the companies
to carry out an evaluation that includes a user-
evaluation among diabetics. The results of the
evaluation must fulfil the quality goals set in ISO
15197. Accu-Chek Compact Plus, Accu-Chek Aviva
and Accu-Chek Sensor are meters designed for
glucose self-measurements by diabetics. The meters
are produced and supplied by Roche Diagnostics.
Accu-Chek Compact Plus was launched onto the
Norwegian market in May 2005, Accu-Chek Aviva
in July 2005 and Accu-Chek Sensor in 1998. The
evaluations of Compact Plus and Aviva were done
under the direction of SKUP during the spring of
2005, and the evaluation of Sensor during the
autumn of 2005.
The aim of the evaluations
The aim of the evaluations is to
- reflect the analytical quality under standardised
and optimal conditions, performed by biomedical
laboratory scientists
- reflect the analytical quality achieved by the
users (approximately 240 diabetics participated
in the three evaluations)
- compare the analytical quality among diabetics
with and without training
- compare the analytical quality among diabetics
before and after three weeks of practise
- check the variation between three lots of test
strips
- examine if hematocrit interferes with the measu-
rements
Accu-Chek Compact Plus Glucose
Accu-Chek Aviva Glucose
Accu-Chek Sensor Glucose
Av Grete Monsen, SKUP (grete.monsen@noklus.no)
Summary of three evaluations organised by SKUP
Report SKUP/2005/43, SKUP/2005/44 and SKUP/2006/48
- evaluate the user-friendliness of the device
- evaluate the user-manual
Materials and methods
Approximately 80 diabetics took part in each
evaluation. One group of participants had two
consultations (the “training group”) and the other
group had one consultation (the “mail group”).
At the first consultation the diabetics in the “trai-
ning group” were given a standardised instruction
about the device before they did a finger prick and
performed two measurements with the meter. The
biomedical laboratory scientist also took capillary
samples of the diabetics and measured twice at
the device. In addition, two capillary samples were
taken to a designated comparison method. The
“mail group” received the device by mail and no
training was given. Both groups of diabetics car-
ried out a practice period of three weeks at home,
before they were called for a second consultation.
The same blood glucose sampling and measurement
procedures were repeated, and in addition a sample
for hematocrit was taken. Three different lots of
test strips were used in the evaluation. All the par-
ticipants finally answered questionnaires about the
user-friendliness and the user-manual.
Results, Accu-Chek Compact Plus
Accu-Chek Compact Plus shows acceptable preci-
sion. The CV is approximately 3 % under standardi-
sed and optimal measuring conditions and between
3 and 6 % when the measurements are performed
by diabetics.
The agreement with a designated comparison
method is good. Quality goals set in ISO 15197 are
(Fortsætter side 42)
