5. Performance characteristics ABL800 FLEX Reference Manual
Performance test results - bilirubin
Explanation
As the optical system is unchanged in the ABL800 FLEX analyzers compared to
the ABL700 Series, the specifications for bilirubin have not been re-established.
Field test results
The ABL735/30 performance specifications for bilirubin were made as a field test
the purpose of which was to optimize bilirubin algorithm for neonatal blood
samples.
For neonatal use: The bilirubin method has been evaluated on whole blood
and plasma. The allowed analytical error is ± 10 % to
satisfy average clinical requirements for bilirubin
measurement [1,2,3,4,5]. This requirement is fulfilled for
plasma. For whole blood the analytical error is slightly
higher. The clinicians and clinical chemists have evaluated
bilirubin measurement on whole blood, the conclusion
being that the ABL735/30 has satisfactory performance
and can substitute other bilirubin measuring methods.
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).
In these cases it is recommended to measure bilirubin on
plasma or serum.
Adult samples with an increased bilirubin level:
Adult field tests were typically performed on samples with
80 % of the total bilirubin in the conjugated form. For these
highly conjugated samples the field tests showed a negative
bias of 7 % on both plasma and whole blood samples.
The patient samples represented typical variations in ctBil, ctHb, sO
2
, pH and
MCHC values.
A Hitachi calibrated with NIST SRM 916a standards was used as a reference. ctBil
was measured in µmol/L. Each field test place had its own ABL735.
Continued on next page
5-40
To Next Page
Loading...
Need help?
General
