Klinisk Biokemi i Norden Nr 2, vol. 28, 2016 - page 14

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Klinisk Biokemi i Norden · 2 2016
Analytical methods
The tubes were Venosafe® Plastic Tubes also used in
daily routine: Serum Gel - VF-052SAS (various lot
no.) The samples were centrifuged for app. 10 min.
at 1300 – 2000 x G according to tube manufacturer’s
instruction.
Inclusion criteria were samples from men. The
components analysed were: Prostate Specific Antigen
and C – Peptide, analysed on Wallac AutoDELFIA
using a commercial kit from PerkinElmer. Parathy-
roid hormone was analysed on Immulite 2000 using
a commercial kit from Siemens and Calcium ion (pH
7, 4) was analysed on ABL 800 from Radiometer.
The components were analyzed at the Dept.
of Clinical Chemistry and Clinical Pharmacology,
Odense University Hospital.
The “0-sample” was centrifuged, and separated at
the doctor’s office within 45 – 60 min and sent to the
laboratory within 4 hours and analyzed immediately
upon arrival. The sample was considered as the best
estimate of a “true” comparison value. The other
samples were kept in thermostated boxes at 21° C and
transported with the established transport system (by
courier in thermostated vehicles at 21° C) from the
GP’s office to the laboratory.
Part 2
Subjects
The adult patients that were undergoing routine
venous puncture at their GP’s were asked to parti-
cipate. Extra 4 tubes were drawn and submitted to
different pre-analytical conditions. All tubes were
drawn between 8 a.m. and app. 11:45 a.m. The sam-
ple handling and the pre-analytical conditions were
carried out by the GP’s staff, nurses, secretaries, or
laboratory technologists. 4 different GPs participated.
Transport
The tubes drawn were transported by the established
transport system.
Tube no 1 was transported by the first courier.
Tube no 2 was transported by the second courier
and tube no 3 was transported the next day with the
first courier. All tubes were analysed at arrival to the
laboratory. The tubes were stored and transported
at 21 ± 1° C.
Analytical methods
The tubes were the normally used Venosafe FC
mixture (3 ml) for P – Glucose and BD Vacutainer
NaCitrate (4.5 ml) for Protime/INR.
Glucose in plasma was analysed with commer-
cial Hexokinase/G6PDH Kit on Abbott Architect.
Protime/INR in plasma was analysed with Owren
method (modified), commercial SPA+ reagent with
STA-R, Stago.
The tube which was transported to the laboratory
with the first courier and analysed within 5 hours
from blood sampling is used as “0 – sample”
Part 3
Subjects
Adult patients (app. 30) that were undergoing routine
venous puncture at their GP were asked to participate.
Extra 2 tubes were drawn and submitted to different
pre-analytical conditions. All 3 tubes were drawn
between 8 a.m. and app. 12 a.m. The sample handling
and the pre-analytical were carried out by the GP’s
staff, nurses, secretaries or laboratory technologists.
3 different GPs participated.
Transport
The tubes drawn were sent by the established trans-
port system.
Tube no 1 was transported by the first courier.
Tube no 2 was transported by the second courier and
tube no. 3 was transported the next day with the first
courier. All tubes were analysed upon arrival at the
laboratory. The tubes were stored and transported
at 21 ± 1° C.
Analytical methods
The tubes were the normally used BD Vacutainer K2
EDTA (4, 0 ml).
The included hematology parameters were anal-
ysed on Sysmex XN 9000
The tube which was transported to the laboratory
with the first courier and analysed within 5 hours
from blood sampling is used as “0 – sample”
Analytical quality goals
Limits for acceptable deviation from the “0 – sample”
result were predefined by the authors of this paper
(table 2, 3 and 4). CLIA rules (as cited in Tietz) (2)
and the relevance of the components for the GP’s
was taken into consideration (3). Because the ana-
lytical coefficient of variation (CV) % for the single
component in the laboratory influences both the “0
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