The determination of the 99th centile level for troponin assays in an Australian reference population

Ann Clin Biochem 2008;45:275-288
doi:10.1258/acb.2007.007185
© 2008 Association for Clinical Biochemistry

 

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Original Articles


Jillian R Tate1,
Wendy Ferguson1,
Renze Bais2,
Karam Kostner3,
Thomas Marwick3 and
Andrew Carter1


1 Chemical Pathology Department, Pathology Queensland, Royal Brisbane and Women’s Hospital, Herston QLD 4029, Australia;
2 Clinical Biochemistry, PaLMS, Royal North Shore Hospital, Sydney NSW 2065, Australia;
3 Department of Medicine, University of Queensland, Princess Alexandra Hospital, Brisbane QLD 4102, Australia


Corresponding author: Ms Jillian Tate. Email: jill_tate{at}health.qld.gov.au


Background: Current guidelines for the diagnosis and risk assessment ofpatients presenting with myocardial infarction recommend a singledecision cut-off point for cardiac troponin (cTn) based on the99th centile of a reference population. The 99th centile levelfor eight troponin assays was determined in an apparently cardio-healthyAustralian reference population.

Methods: Nine laboratories measured troponin in serum and plasma collectedfrom 111 reference individuals. An imprecision profile was determinedusing up to 10 serum samples analysed on 10 separate days. Methodcomparison using 100 routinely tested plasma samples was performedto estimate method concordance.

Results: Generally 99th centile values determined in this study werelower than, or the same as manufacturers’ levels, except forcTnI by Architect (0.020 vs. 0.012 µg/L), and imprecisionat the 99th centile was 20% coefficient of variation (CV) orhigher. Troponin concentrations at 10% CV were greater thanthose quoted in the manufacturer’s package insert except byAxSYM, 0.06 vs. 0.16 µg/L cTnI, and by E-170, 0.02 vs.0.03 µg/L cTnT. In the method comparison 74, 70, 65, 75,58, 66, 58 and 77 samples measured by Access, Architect, AxSYM,Centaur, Dimension RxL, E-170, i-STAT and Vitros ECi assays,respectively, had troponin concentrations above the study 99thcentile.

Conclusions: Depending on the selected reference population for troponin,there is likely to be variability in the 99th centile as shownin this study. Some differences in sample concordance at the99th centile cut-off were observed between cTn methods and mayresult in different clinical classification.

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