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Klinisk Biokemi i Norden · 2 2018
Summary of an evaluation
organised by SKUP
Grete Monsen and Marianne Risa, on behalf of SKUP
Accu-Chek Guide
for measurement of glucose
Background
Accu-Chek Guide is an in vitro device for quantita-
tive measurement of glucose (Figure 1). The product
is designed for monitoring and intended for both
people with diabetes and health care professionals.
The sample material is whole blood, preferably capil-
lary blood. The system is produced by Roche Diabetes
Care GmbH and was launched into the Scandinavian
market in October 2016. The SKUP evaluation was
carried out in October 2016 at the request of Roche
Diabetes Care Norge AS.
The aim of the evaluation
The aim of the evaluation was to assess the analy-
tical quality and user-friendliness of Accu-Chek
Guide, both when used under optimal conditions by
experienced laboratory personnel and under real-life
conditions by intended users (people with diabetes).
Materials and methods
A total of 90 people with diabetes participated in the
evaluation. All participants received the device and
instructions by mail and no training was given. They
used the device for approximately two weeks at home,
before attending an evaluation meeting with SKUP.
Fresh capillary whole blood samples from each par-
ticipant were analysed on Accu-Chek Guide under
optimal conditions as well as by the participants.
Three lots of test strips were used. Capillary samples
from the same individuals were analysed on a com-
parison method (a glucose hexokinase method for
measurement of glucose in plasma, implemented on
Roche Cobas 6000). The analytical results were asses-
sed according to pre-set quality goals. The quality
goal for imprecision was a repeatability (CV) ≤5,0
%. The quality goal for accuracy was set according
to the International Organization for Standardiza-
tion (ISO) ISO 15197:2013, which states that at least
95 % of the individual glucose results shall be within
<±0,83 mmol/L of the average measured values of the
reference measurement procedure at glucose concen-
tration <5,55 mmol/L or <±15 % at glucose concentra-
tion ≥5,55 mmol/L. The user-friendliness was asses-
sed using a questionnaire with three given ratings;
satisfactory, intermediate and unsatisfactory, and
with the quality goal of a total rating of “satisfactory”.
Results
The CV achieved under optimal conditions was bet-
ween 1,5 and 2,6 %, depending on the concentration
level. The intended users achieved a CV between 1,8
and 3,9 %. There was a bias of (–0,1) — (–0,8) mmol/L
between Accu-Chek Guide and the comparison met-
hod, also depending on the concentration level. Both
when used under optimal conditions by experienced
laboratory personnel, and when handled by the
intended users, all results were within the allowable
deviation limits for accuracy (Figure 2 and 3). Glucose
measurements on Accu-Chek Guide were not affected
by haematocrit in this evaluation (haematocrit range
in the samples was 31—50 %). The fraction of tests
wasted caused by technical errors was 0,8 %. The
user-friendliness was rated as satisfactory.
Figure 1.
The Accu-Chek Guide system
