Annals of Clinical Biochemistry > Volume 45, Number 3 > Pp. 316-317

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

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. In this study, the Advia Centaur second-generation TnI-Ultra assay was validated and compared with its predecessor the cardiac troponin I (cTnI) assay, with a focus on the current guidelines for diagnosis of acute myocardial damage.

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

Results: The cTnI concentration that could be determined with a total imprecision of 10% was 0.05 µg/L for the TnI-Ultra assay and 0.3 µg/L for the cTnI assay. The 99th percentile limit in the distribution of a reference population was 0.06 µg/L as 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 distribution of a reference population. Using the TnI-Ultra assay, slightly increased cTnI concentration can be detected reliably following the current guidelines.

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