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Cardiac Troponin Assay Classification by Both Clinical and Analytical Performance Characteristics: A Study on Outcome Prediction
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Biochemial structure and function.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
2013 (English)In: Clinical Chemistry, ISSN 0009-9147, E-ISSN 1530-8561, Vol. 59, no 6, 976-981 p.Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Cardiac troponin assays have been classified according to whether they measure the 99th percentile concentration of a healthy reference population with imprecision (expressed as CV) of <= 10%, between 10% and 20%, or >20%. Assays in these categories have been deemed "guideline acceptable," "clinically usable," or not acceptable," respectively. We compared four widely used "clinically usable" cardiac troponin I (cTnI) assays with an assay designated "not acceptable" for accuracy in predicting the clinical outcome of death. METHODS: Blood was collected from 259 men and 249 women, mean (SD) age 68.8 (17.8) and 70.2 (17.8) years, respectively, admitted to the emergency department for suspected myocardial infarction. We measured cTnI by the Access, Architect, i-Stat, Stratus CS, and VIDAS assays. Deaths in this population were recorded over a 31-month period. RESULTS: We found VIDAS cTnI assay measurement CVs of 10% and 20% at concentrations of 0.04 and 0.02 mu g/L, respectively. Comparing at the 10% CV cutoff concentration, VIDAS cTnI was less sensitive than the Access and Architect assays (P < 0.001) but more sensitive than i-Stat (P < 0.001) and Stratus CS (P < 0.001) in identifying patients with poor outcomes. At the 20% CV cutoff, the VIDAS assay was equivalent to the other assays in identifying patients with poor outcomes. CONCLUSIONS: For outcome prediction, the VIDAS cTnI assay was clinically equivalent or superior to other cTnI assays judged to be acceptable from a pure analytical standpoint. Thus, comparison of cardiac troponin assays should consider not only ana-lytical performance, but also clinical performance characteristics.

Place, publisher, year, edition, pages
2013. Vol. 59, no 6, 976-981 p.
National Category
Medical and Health Sciences
URN: urn:nbn:se:uu:diva-205380DOI: 10.1373/clinchem.2012.194928ISI: 000321548500017OAI: oai:DiVA.org:uu-205380DiVA: diva2:644455
Available from: 2013-08-30 Created: 2013-08-16 Last updated: 2013-08-30Bibliographically approved

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Venge, PerLindahl, Bertil
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Biochemial structure and functionUCR-Uppsala Clinical Research Center
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