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35
| 2 | 2005
Klinisk Biokemi i Norden
a high anticoagulation effect. Both capillary and
venous blood samples can be measured, but with
two different kinds of cuvettes.
Results.
The analytical quality and the user friendli-
ness are regarded equally important.
The results with Hemochron using venous samples
and capillary samples under optimal conditions in a
hospital laboratory and in two general practices are
seen in the table. Total Error are visualised for the
Hemochron method and a hospital method in figure
1 and 2 respectively.
User friendliness
evaluated with venous samples:
The ratings of the ‘Information in Manual’, ‘Time
factors’ and ‘Operation’ were all ‘satisfactory’ both
in the hospital laboratory and in the primary care
while ‘Quality control’ was not ‘satisfactory’. The
results of the ‘low therapeutic value, INR 1,6’ con-
trol had a CV of 11.8 %. This means, that it cannot
be recommend as a tool for control or troubleshoot-
ing. The ‘high therapeutic value, INR 4,6’ control
had a CV of 6.0 %, which is also too high.
Conclusion
Hemochron does not fulfil the
quality goals set up by SKUP (or the Danish
‘Laboratorieudvalget’¹) for analytical imprecision
(CV
within
) and total error in this evaluation, neither
with venous nor with capillary samples. The within-
series imprecision was > 5 % for both venous and
capillary samples. The Total Error was < 20 % for
only 84 % of the results with venous samples. The
user friendliness of ‘Manual’, ‘Time factors’ and
‘Operation’ for venous samples were regarded as
satisfactory, while ‘Quality control’ was not.
The complete Hemochron evaluation report inclu-
sive comments from the manufacturer ITC is avail-
able at www.SKUP.nu or www.SKUP.dk
References
1 Laboratorieudvalget under ”Faglig Udvalg
vedr. Almen Praksis”. Kvalitetskrav og kva-
litetsvurderingssystem for hyppigt udførte
klinisk biokemiske og klinisk mikrobiologiske
analyser i almen praksis. November 2003.
Figure 2. Total Error. Routine method
in the hospital laboratory
This figure can be explained as fig-
ure 1, but this is the results of the
samples with the hospital laboratory
method. The hospital laboratory fulfils
the goals.
(Fortsat fra side 29)
Igelkott. Foto: Henrik Alfthan.
