• Aldo Clerico, Andrea Ripoli, Martina Zaninotto, Silvia Masotti, Veronica Musetti, Marcello Ciaccio, Rosalia Aloe, Sara Rizzardi, Ruggero Dittadi, Cinzia Carrozza, Tommaso Fasano, Marco Perrone, Antonio de Santis, Concetta Prontera, Daniela Riggio, Cristina Guiotto, Marco Migliardi, Sergio Bernardini, and Mario Plebani.
• Laboratorio Clinico, Fondazione CNR-Regione Toscana, G. Monasterio e Scuola Superiore Sant'Anna, Pisa, Italy. Electronic address: clerico@ftgm.it.
• Clin. Chim. Acta. 2019 Sep 1; 496: 25-34.

BackgroundThe study aim is to compare cTnI values measured with three high-sensitivity (hs) methods in apparently healthy volunteers and patients admitted to emergency department (ED) with acute coronary syndrome enrolled in a large multicentre study.MethodsHeparinized plasma samples were collected from 1511 apparently healthy subjects from 8 Italian clinical institutions (mean age: 51.5 years, SD: 14.1 years, range: 18-65 years, F/M ratio:0.95). All volunteers denied chronic or acute diseases and had normal values of routine laboratory tests. Moreover, 1322 heparinized plasma sample were also collected by 9 Italian clinical institutions from patients admitted to ED with clinical symptoms typical of acute coronary syndrome. The reference study laboratory assayed all plasma samples with three hs-methods: Architect hs-cTnI, Access hs-cTnI and ADVIA Centaur XPT methods. Principal Component Analysis (PCA) was also used to analyze the between-method differences among hs-cTnI assays.ResultsOn average, a between-method difference of 31.2% CV was found among the results of hs-cTnI immunoassays. ADVIA Centaur XPT method measured higher cTnI values than Architect and Access methods. Moreover, 99th percentile URL values depended not only on age and sex of reference population, but also on the statistical approach used for calculation (robust non-parametric vs bootstrap).ConclusionsDue to differences in concentrations and reference values, clinicians should be advised that plasma samples of the same patient should be measured for cTnI assay in the same laboratory. Specific clinical studies are needed to establish the most appropriate statistical approach to calculate the 99th percentile URL values for hs-cTnI methods.Copyright © 2019 Elsevier B.V. All rights reserved.

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