RADIOMETER FLEX ABL90, Reference Manual

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ABL90 FLEX reference manual 7. Performance characteristics
7-19
For adult use: Adult samples within reference range:
The uncertainty in the bilirubin measurement on whole
blood can, in some cases, exceed the level required to
measure normal bilirubin levels for children older than 3
months and adults (bilirubin reference range
4-22 µmol/L).
Adult samples with an increased bilirubin level:
External tests using adult samples were performed on
samples with typically 80 % of the total bilirubin in the
conjugated form. For these highly conjugated samples
the external tests showed a negative bias of 18% on
whole-blood samples.
The patient samples represented typical variations in ctBil, ctHb, sO
2
, pH and MCHC
(Mean Corpuscular Hemoglobin Concentration) values.
Three external tests were carried out at two different sites. Each test had its own ABL90
analyzer – a total of three.
Wet Chemistry analyzer Roche Modular with Roche Calibrator was used as a reference
[Ref. 21]. Each external test site had two Modulars – a total of four. ctBil was measured
in  mol/L.
The field test results are given below:
S
yx
is the spreading around the linear line.
Actual external test from neonatal critical care hospitals using whole blood. Data from
three field tests are merged. Values are in µmol/L.
y = 1.014x - 0.828
R 2 = 0.985
0
50
100
150
200
250
300
350
400
0 100 200 300 400
Modular
AB
L
9
0
Syx=11.6
N=175