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44
| 2 | 2007
Klinisk Biokemi i Norden
EliA
™
on ImmunoCAP
™
250
Automation and quality both in allergy
and autoimmunity testing
State of the arts analytes
EliA
™
CCP and EliA
™
Celikey
Phadia AB
Marknadsbolag Sverige
Box 6460
SE-751 37 Uppsala
Phadia AS
Nydalsveien 33
Postboks 4814, Nydalen
NO-0422 Oslo
Phadia OY
Rajatorpantie 41 C
FIN-01640 Vantaa
www.phadia.com
Phadia Aps
Gydevang 33
DK-3450 Allerød
time met the ISO-requirements. Subsequent SKUP-
evaluations confirmed this. As a consequence, the
results by the diabetics have been discussed towards
a modified goal suggested by NOKLUS, with a total
error of ± 25 %. This modified goal has wide, and
not ideal, limits. The intention was to tighten up the
modified requirements for the diabetics over time,
as the meters would hopefully improve due to tech-
nological development. More recent evaluations
performed by SKUP clearly show that the quality
goals set by ISO 15197 now can be achieved also
by the diabetics. But for the time being, the quality
demands adjusted to the diabetics’ self-measure-
ments, still apply.
The evaluation model
77 diabetics took part in the first evaluation and 81
diabetics participated in the supplementary evalua-
tion. In the first evaluation, 40 of the participants
had two consultations (the “training group”) and
the rest had one consultation (the “mail group”).
The diabetics in the training group were given a
standardised instruction about the Precision-system
before they did a finger prick and performed two
measurements on the meter. The biomedical labo-
ratory scientist also took samples from a finger
capillary of the diabetics and measured twice with
the system. In addition, two samples from a finger
capillary were taken to a designated comparison
method. The diabetics in the mail group received
the Precision-system by mail and no training was
given. Both groups of diabetics carried out a prac-
tice period of approximately three weeks at home,
before they were called for a final consultation. The
blood glucose sampling and measurement procedu-
res at the first consultation were repeated, and in
addition a sample for hematocrit was taken. Three
different lots of test strips were used in the evalua-
tion. All the participants finally answered questi-
onnaires about the user-friendliness of Precision
Xtra Plus/Precision Xceed and the user-manual of
Precision Xceed.
For the supplementary evaluation 48 diabetics
were recruited from the first user-evaluation and 33
diabetics were recruited through Sørlandet Hospital.
The diabetics in the supplementary evaluation had
only one consultation. The measuring procedure was
similar to the procedure in the first user-evaluation.
Results
The results from the first user-evaluation are only
presented in an attachment to the report.
The results from the supplementary user-
evaluation:
– Under standardised and optimal measuring condi-
tions, the repeatability CV of Precision Xtra Plus on
Precision Xceed was approximately 6 %. The impre-
cision was a little higher for glucose concentrations
< 7 mmol/L. When measured by the diabetics, the
precision was acceptable with a CV of approxima-
tely 5 % for glucose concentrations > 7 mmol/L. As
a whole the imprecision was not significantly higher
than 5 %.
– The Precision Xtra Plus showed slightly higher
glucose results than the comparison method. The
positive bias was approximately 4 to 5 % for glucose
values < 10 mmol/L. The bias is statistical signifi-
cant, but the deviation from the comparison method
is hardly of any importance. The negative bias that
was pointed out in the first evaluation was more
than compensated.
– Two of the three lots of test strips showed signifi-
cantly higher values than the comparison method.
The deviation was approximately 4 %.
– The quality goal set in the ISO 15197 was achieved
under standardised and optimal measuring condi-
tions as well as by the diabetics.
– Glucose measurements at Precision Xtra Plus test
strips at Precision Xceed did not seem to be affected
by hematocrit values between 35 and 49 %.
– The diabetics summarised the Precision-device as
easy to use. The diabetics that had used the user
manual were satisfied with the manual.
Conclusion
The imprecision of Precision Xtra Plus test strips
at Precision Xceed under standardised and optimal
measuring conditions and in use by the diabetics
was just above 5 % as a whole. Glucose results at
Precision Xtra Plus were approximately 4 to 5 %
higher than at the comparison method for glucose
values < 10 mmol/L. The quality goal set in the
ISO-guide 15197 was achieved under standardised
and optimal measuring conditions as well as by
the diabetics. The glucose measurements did not
seem to be affected by hematocrit-values between
35 and 49 %. The users found the Precision-device
easy to use.
(Fortsat fra side 42)
