Abbreviations
The investigated combinations of pre-analytical circumstances
are designated A1 to A7 and B1 to B6 for Centre A and
Centre B, respectively. Explanation of these codes is given
in Tables 1 and 2.
Analytical methods
The GPs in Centre A used VenoSafe Lithium Heparin gel
tubes (Lot 0510051) from Terumo Medical Incorporation,
Leuven, Belgium. In Centre B, Lithium Heparin tubes with gel
from Becton Dickinson, BD Diagnostics, Plymouth, England
were used.
All involved participants centrifuged the samples for
7–10 min at 1300–2000=g according to tube manufacturer’s
instructions.
The investigated components are listed in Table 3. The
inclusion criterion was that all components could be analysed
in a single tube. Thus, components such as glucose,
demanding a special blood sampling tube were not
considered.
Plasma concentrations of all investigated components
were analysed in both centres on Modular P from Roche
Diagnostics, with commercial kits from Roche Diagnostics
GmbH, Mannheim, Germany.
A ‘‘0-sample’’ was the blood sample taken, centrifuged
and separated at the doctor’s office within 45–60 min and
considered as the best estimate of a ‘‘true’’ comparison value.
Thereafter, the plasma is considered stable during the
designed protocol period (5–7). The ‘‘0-samples’’ were handled
by laboratory (temperature regulatedsthermostated)
boxes, able to keep a temperature of 21"18C, and were purchased
from ViboCold, Viborg, Denmark.
Analytical quality goals
Limits for acceptable deviation from the 0-sample results
were pre-defined by the authors of this paper (Table 3). CLIA
rules was cited in Tietz (8)x and the relevance of the components
for the GPs were taken into consideration.
Because the analytical coefficient of variation (CV)% for the
single component in the laboratories influences both the
comparison sample ‘‘0’’ and the transported samples, and
because the biological and sampling variations are eliminated
as samples are taken in the same puncture, the total
acceptable difference was defined as follows:
SD 2sSD 2 Total acceptable deviation Acceptable pre-analytical deviation
2 q2=SDanalytical .
The quality demand was that at least 95% of the measurements
had to be within 2 SDTotal deviation from the 0-sample.
Outliers The 0-sample results were checked by Burnett’s
model (9) and no outliers were found. Outliers for the single
test sample were not excluded and the sample was not reanalysed.
Statistics
The number of results exceeding quality limits for the single
transport form was tested for significance against transport
Abbreviations
The investigated combinations of pre-analytical circumstances
are designated A1 to A7 and B1 to B6 for Centre A and
Centre B, respectively. Explanation of these codes is given
in Tables 1 and 2.
Analytical methods
The GPs in Centre A used VenoSafe Lithium Heparin gel
tubes (Lot 0510051) from Terumo Medical Incorporation,
Leuven, Belgium. In Centre B, Lithium Heparin tubes with gel
from Becton Dickinson, BD Diagnostics, Plymouth, England
were used.
All involved participants centrifuged the samples for
7–10 min at 1300–2000=g according to tube manufacturer’s
instructions.
The investigated components are listed in Table 3. The
inclusion criterion was that all components could be analysed
in a single tube. Thus, components such as glucose,
demanding a special blood sampling tube were not
considered.
Plasma concentrations of all investigated components
were analysed in both centres on Modular P from Roche
Diagnostics, with commercial kits from Roche Diagnostics
GmbH, Mannheim, Germany.
A ‘‘0-sample’’ was the blood sample taken, centrifuged
and separated at the doctor’s office within 45–60 min and
considered as the best estimate of a ‘‘true’’ comparison value.
Thereafter, the plasma is considered stable during the
designed protocol period (5–7). The ‘‘0-samples’’ were handled
by laboratory (temperature regulatedsthermostated)
boxes, able to keep a temperature of 21"18C, and were purchased
from ViboCold, Viborg, Denmark.
Analytical quality goals
Limits for acceptable deviation from the 0-sample results
were pre-defined by the authors of this paper (Table 3). CLIA
rules was cited in Tietz (8)x and the relevance of the components
for the GPs were taken into consideration.
Because the analytical coefficient of variation (CV)% for the
single component in the laboratories influences both the
comparison sample ‘‘0’’ and the transported samples, and
because the biological and sampling variations are eliminated
as samples are taken in the same puncture, the total
acceptable difference was defined as follows:
SD 2sSD 2 Total acceptable deviation Acceptable pre-analytical deviation
2 q2=SDanalytical .
The quality demand was that at least 95% of the measurements
had to be within 2 SDTotal deviation from the 0-sample.
Outliers The 0-sample results were checked by Burnett’s
model (9) and no outliers were found. Outliers for the single
test sample were not excluded and the sample was not reanalysed.
Statistics
The number of results exceeding quality limits for the single
transport form was tested for significance against transport
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