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14
Klinisk Kjemi i Norden 1, 2002
Description of Biotest
The Biotest Hemoglobin Measuring System (Biotest)
is manufactured by Biotest Medizintechnik GmbH,
Germany and is used for determination of the haemo-
globin concentration in human blood. Biotest consists
of an absorption photometer called Biotest Hemoglobin
Tester and of Biotest Hemoglobin disposable micro-
cuvettes which contain dried reagents. In the cuvettes,
haemoglobin is converted to azide methaemoglobin.
The system measures the endpoint of the reaction
bichromatically.
It is possible to draw the sample, 10 µL blood, directly
into the Biotest cuvette from a capillary puncture. The
cuvette can be read almost immediately in the Biotest
Hemoglobin Tester. The measuring range is 0 – 256 g/L.
Scope of the evaluation
The evaluation comprises the following studies:
- Within-day imprecision
- Between-day imprecision
- Linear agreement of Biotest to a designated compa-
rison method with venous and capillary samples
- Practical viewpoints from the users
The evaluation was carried out both in the Department
of Clinical Chemistry, Malmö University Hospital,
Sweden and in two connected primary care centres.
The comparison method was the haemoglobin method
on the cellcounter Coulter GenS.
Results
The testing with venous samples in the department of
clinical chemistry showed that the within-series impre-
cision for Biotest with venous EDTA samples was good
Prosjektbeskrivelse
Ansvarlig: Sverre Sandberg, fax +47 55 58 67 10, E-post: sverre.sandberg@isf.uib.no
Haemoglobin with Biotest
Summary of an evaluation organised by SKUP
Report SKUP/2001/17
ARNE MÅRTENSSON, SKUP Sverige, (arne.martensson@equalis.se
)
with CV around 0,7 %. The between-day impre-
cision was good. This CV was 1,2 %.
The linear correlation between Biotest and the
comparison method was also good. The values
from Biotest are slightly lower, on average -1,9
% (or -2,6 g/L), than the values from the compa-
rison method. However, this small deviation is
of no clinical importance. Testing in the two
primary care centres showed similar results to
those obtained in the department of clinical
chemistry.
The testing with capillary samples in the primary
care centres showed acceptable within-series
imprecision in both centres. However, the CV-
values varied from 0,9 % in one centre to 3,0 % in
the other. The difference illustrates that impre-
cision can vary depending on the type of lancet
used, sampling technique and the skill of the
sample collector. An important preanalytical
source of error is that the haemoglobin concen-
trations in capillary puncture blood often deviate
from that in the corresponding venous blood. The
linear correlation between Biotest and the compa-
rison method was accordingly less good compared
to venous blood.
All personnel involved in the evaluation summari-
sed their practical points of view about the Biotest
system as being quick and easy to use.
Conclusion
Biotest showed good precision when using venous
samples. The Biotest results had a good linear
correlation with, and showed only small deviations
