RADIOMETER ABL800 FLEX, Reference Manual

Page: 112 / 206

5. Performance characteristics ABL800 FLEX Reference Manual
Performance test results - oximetry
Explanation The optical system is unchanged in the ABL800 FLEX analyzers compared to the
ABL700 Series. Test of
c tHb on the ABL800 FLEX analyzers has been conducted
(results given on pages 5-29 to 5-30). As the other oximetry parameters ( s O
2
,
F O
2
Hb, F COHb, F MetHb, F HHb, F HbF) are derived from c tHb, these parameters
have not been re-tested; the information and results below are from the ABL700
Series.
Primary
reference
method The reference method established for the oximetry parameters uses modified
ABL520 analyzers as the reference instruments. The ABL520 analyzers have been
validated and their performance specifications determined according to primary
reference methods.
The modified ABL520 analyzers are used in accordance with IFCC’s
recommendations for traceability of reference methods.
The reference methods used for the oximetry parameters on the ABL520 analyzers
are those presented below.
Parameter Primary reference method
s O
2
Tonometry: whole blood is tonometered with a gas
mixture containing 94.4 % O
2
and 5.6 % CO
2
.
F HHb The standard is blood ( c tHb = 13 - 15 g/dL) treated
with dithionite.
F COHb Gas chromatography. The standards are carbon
monoxide mixtures with atmospheric air, whose
purity is validated in accordance with NIST SRM
1678 (50 ppm CO in N
2
).
F MetHb
Spectrometry, modified Evelyn-Malloy method
[
7
]
.
F HbF
Alkali denaturation method
[
8
]
. Corresponds to
NCCLS guideline
[
9
]
.
Test conditions
for oximetry
parameters
Test Description
Reference To verify that the correction constants have been
accurately determined, 10 analyzers with all
parameters available are tested in C195 mode against
the reference methods.
Each parameter is tested on 3-6 levels over at least 3
days, with 5 repetitions each day.
(5 new analyzers with all parameters available were
tested against the reference methods for
F HbF).
Bias for each parameter in the C195 measuring mode
against the reference method is determined.
Continued on next page
5-30