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42
| 3 | 2006
Klinisk Biokemi i Norden
43
| 3 | 2006
Klinisk Biokemi i Norden
Your choice for Troponin testing is about to get easier.
Bayer HealthCare, Diagnostics Division has launched a new
Troponin assay (Tnl-Ultra™) as part of its extensive cardiovascular test
menu that also includes CK-MB, Myoglobin, Homocysteine and BNP.
You asked that we keep pace with changes in medical practice, and we are
set to deliver. TnI-Ultra™, the first fully automated assay meeting the ESC/ACC -
recommendation of ≤ 10% imprecision at 99th percentile of a healthy population.
Differential diagnosis, dynamic productivity.
For more information on Tnl-Ultra™
contact your local Bayer HealthCare representative or log onto www.labnews.com.
Bayer Tnl-Ultra™
BEYOND
Belief
Denmark
Bayer HealthCare
Diagnostics Division
Telephone: +45 4523 5000
Sweden
Bayer HealthCare
Diagnostics Division
Telephone: +46 3183 9800
Norway
Bayer HealthCare
Diagnostics Division
Telephone: +47 2411 1800
Finland
Bayer HealthCare
Diagnostics Division
Telephone: +358 9 887 887
Your choice for Troponin testing is about to get easier.
Bayer HealthCare, Diagnostics Division has launched a new
Troponin ssay (Tnl-Ultra™) as part f its extensive cardiovascular test
menu that also includes CK-MB, Myoglobin, Homocysteine nd BNP.
You asked that we keep pace with changes in medical practice, and we are
set to d liver. TnI-Ultra™, th first fully automated assay meeting the ESC/ACC -
r commendatio of ≤ 10% imprecision t 99th percentile of a healt y population.
Differential diagnosis, dynamic productivity.
For more information on Tnl-Ultra™
contact your local Bayer HealthCare representative or log onto www.labnews.com.
Bayer Tnl-Ultra™
BEYOND
Belief
Denmark
Bayer HealthCare
Diagnostics Division
Telephone: +45 4523 5000
Sweden
Bayer HealthCare
Diagnostics Division
Telephone: +46 3183 9800
Norway
Bayer HealthCare
Diagnostics Division
Telephone: +47 2411 1800
Finland
Bayer HealthCare
Diagnostics Division
Telephone: +358 9 887 887
achieved under standardised and optimal measuring
conditions, and at the final consultation even the
quality goals set by ADA are achieved. When hand-
led by the diabetics, Accu-Chek Compact Plus also
shows accurate results. All these results are within
the “adjusted ISO-goal” (± 25 %) and the results also
fulfil the quality goals set in ISO 15197 (Fig. 1).
One of the three lots of test strips that were used
showed significantly lower values than the compa-
rison method. In spite of this deviation, the results
attain the quality goal.
Glucose measurements at Accu-Chek Compact
Plus seem to be affected by the hematocrit values of
the samples in higher degree than described in the
package insert. Glucose values are over-estimated
when the hematocrit is below 35 %. With hema-
tocrit values over approximately 45 % the glucose
values are under-estimated.
The diabetics summarise the Accu-Chek Compact
Plus device as easy to use. Most of them were
pleased with the device. The diabetics that had used
the user manual were satisfied with the manual.
Results, Accu-Chek Aviva
Accu-Chek Aviva shows acceptable precision. The
CV is < 5 % under standardised and optimal mea-
suring conditions and approximately 5 % when the
measurements are performed by diabetics.
The agreement with a designated comparison
method is good. Quality goals set in ISO 15197
are achieved under standardised and optimal mea-
suring conditions. When handled by the diabetics,
Accu-Chek Aviva also shows accurate results. These
results are within the “adjusted ISO-goal” and also
within the quality goals set in ISO 15197 (Fig. 2).
Two of the three lots of test strips that were used
showed significantly higher values then the compa-
rison method. In spite of this deviation, the results
attain the quality goal.
Glucose measurements with Accu-Chek Aviva do
not seem to be affected by hematocrit values bet-
ween 28 – 49 %. Hematocrit outside this range has
not been tested.
The diabetics summarise the Accu-Chek Aviva
device as easy to use. Most of them were pleased
with the device. The diabetics that had used the user
manual were satisfied with the manual.
Results, Accu-Chek Sensor
Accu-Chek Sensor shows acceptable precision. The
CV is approximately 3 % under standardised and
optimal measuring conditions and between 2 and
6 % when the measurements are performed by
diabetics.
Accu-Chek Sensor gives glucose values from 0,1
– 0,3 mmol/L higher than the comparison method.
This bias has no importance.
The agreement with a designated comparison
method is good. Quality goals set in ISO 15197 are
achieved under standardised and optimal measuring
conditions. When handled by the diabetics, Accu-
Chek Sensor also shows accurate results. These
results are within the “adjusted ISO-goal” and also
within the quality goals set in ISO 15197 (Fig. 3).
Two of the three lots of test strips that were used
showed significantly higher values than the compa-
rison method. The bias is small, and the results still
attain the quality goals.
Glucose measurements at Accu-Chek Sensor do
not seem to be affected by hematocrit values bet-
ween 35 – 50 %. Hematocrit outside this range has
not been tested.
The diabetics summarise the Accu-Chek Sensor
device as easy to use. Most of them were pleased
with the device. The diabetics that had used the user
manual were satisfied with the manual.
Conclusion
Glucose measurements with Accu-Chek Compact
Plus, Accu-Chek Aviva and Accu-Chek Sensor have
acceptable precision. The accuracy is good. The
results are within the quality goals set in ISO 15197.
Glucose results at Accu-Chek Compact Plus seem to
be affected by hematocrit in a higher degree than
described in the package insert, while the glucose
results at Accu-Chek Aviva and Accu-Chek Sensor
do not seem to be affected by the hematocrit. The
users find the devices easy to use and are quite
satisfied with the devices and the user manuals.
The complete evaluation reports are available at
www.skup.nu
(Fortsat fra side 41)
