Performance of the Advia Centaur second-generation troponin assay TnI-Ultra compared with the first-generation cTnI assay

Ann Clin Biochem 2008;45:316-317
doi:10.1258/acb.2007.007209
© 2008 Association for Clinical Biochemistry

 

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Daan van de Kerkhof,
Berry Peters and
Volkher Scharnhorst


Clinical Laboratory, Catharina Hospital, PO Box 1350, 5602 ZA, Eindhoven, The Netherlands


Corresponding author: Dr D van de Kerkhof. Email: Daan.vd.kerkhof{at}cze.nl


Background: A cardiac troponin concentration above the 99th percentile limit of a reference population is a sensitive marker of myocardial necrosis. Current guidelines require troponin assays to have a total imprecision of 10% at the 99th percentile limit. Inthis study, the Advia Centaur second-generation TnI-Ultra assaywas validated and compared with its predecessor the cardiactroponin I (cTnI) assay, with a focus on the current guidelinesfor diagnosis of acute myocardial damage.

Methods: An imprecision profile of the TnI-Ultra assay was evaluatedby analysing different pools over 20 days. The imprecision ofthe cTnI assay was used as comparison. The reference range wasestablished based on TnI-Ultra analysis in 221 individuals.

Results: The cTnI concentration that could be determined with a totalimprecision of 10% was 0.05 µg/L for the TnI-Ultra assayand 0.3 µg/L for the cTnI assay. The 99th percentile limitin the distribution of a reference population was 0.06 µg/Las determined with the TnI-Ultra assay.

Conclusions: The TnI-Ultra assay provides significantly improved sensitivity when compared with the cTnI assay and a total imprecision of 10% is obtained at the 99th percentile limit of value distributionof a reference population. Using the TnI-Ultra assay, slightlyincreased cTnI concentration can be detected reliably followingthe current guidelines.

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