7. Performance characteristics ABL90 FLEX reference manual
7-6
Test conditions
Test conditions to determine bias
Prim.ref
, bias
Sec.ref
, repeatability, reproducibility and total
variation for pH,
pCO
2
, pO
2
, cCa
2+
, cCl
–
, cK
+
, cNa
+
, cGlu, cLac, ctHb, sO
2
, FO
2
Hb,
FCOHb, FMetHb, FHHb, ctBil and FHbF were as follows:
Item Description
Reference analyzers Five ABL735 analyzers with AutoCheck module were
used as a reference. The capillary mode was used
for
pCO
2
and pO
2
, and the syringe mode for all the
other parameters.
Primary/secondary
reference methods
As specified for each parameter earlier in this
chapter.
Analyzers and test
modes
8-10 ABL90 FLEX analyzers were tested in syringe
and capillary mode.
Blood samples Heparinized blood samples from healthy, voluntary
donors.
The blood is prepared to obtain different
concentration levels of each measured parameter.
Blood measurements Measurements on every parameter are performed
on all analyzers, with 5 measurements on every
sample of each run, repeated for 3 days.
The measurements were performed by different
operators.
Solution pack All calibration solutions and gases used for the tests
are traceable to Primary Reference Standards.
Traceability certificates for the ABL90 FLEX
calibration solutions and gases are found at the end
of chapter 9:
Solutions.
Experimental
conditions
Ambient temperature: 22-25 °C
Relative humidity: 30-50 %.
Barometric pressure: 730 - 780 mmHg
NOTICES: The solutions used in the performance tests are those
recommended by Radiometer. Performances using other
solutions cannot be guaranteed.
The performance tests are performed under conditions where
the analyzers are not influenced by electromagnetic fields.
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