Accessible Requires Authentication Published by De Gruyter March 20, 2019

Evaluation of reference change values for a hs-cTnI immunoassay using both plasma samples of healthy subjects and patients and quality control samples

Veronica Musetti, Silvia Masotti, Concetta Prontera, Rudina Ndreu, Giancarlo Zucchelli, Claudio Passino, Michele Emdin and Aldo Clerico

Corresponding author: Prof. Aldo Clerico, MD, Laboratory of Cardiovascular Endocrinology and Cell Biology, Department of Laboratory Medicine, Fondazione CNR Toscana G. Monasterio, Scuola Superiore Sant’Anna, Via Trieste 41, 56126 Pisa, Italy; and Fondazione CNR Regione Toscana G. Monasterio, Scuola Superiore Sant’Anna, Pisa, Italy

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

References

1. Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, et al. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J 2016;37:267–315. Search in Google Scholar

2. Caselli C, Cangemi G, Masotti S, Ragusa R, Gennai I, Del Ry S, et al. Plasma cardiac troponin I concentrations in healthy neonates, children and adolescents measured with a highly sensitive immunoassay method: Highly sensitive troponin I in pediatric age. Clin Chim Acta 2016;458:68–71. Search in Google Scholar

3. Masotti S, Prontera C, Musetti V, Storti S, Ndreu R, Zucchelli GC, et al. Evaluation of analytical performance of a new high-sensitivity immunoassay for cardiac troponin I. Clin Chem Lab Med 2018;56:492–501. Search in Google Scholar

4. Musetti V, Masotti S, Prontera C, Storti S, Passino C, Zucchelli GC, et al. Evaluation of the analytical performance of a new ADVIA immunoassay using the Centaur XPT platform system for the measurement of cardiac troponin I. Clin Chem Lab Med 2018;56:e229–31. Search in Google Scholar

5. Fraser CG. Reference change values. Clin Chem Lab Med 2011;50:807–12. Search in Google Scholar

6. van der Linden N, Hilderink JM, Cornelis T, Kimenai DM, Klinkenberg LJ, van Doorn WP, et al. Twenty-four-hour biological variation profiles of cardiac troponin I in individuals with or without chronic kidney disease. Clin Chem 2017;63:1655–6. Search in Google Scholar

7. Clerico A, Ripoli A, Masotti S, Prontera C, Storti S, Fortunato A, et al. Pilot study on harmonization of cardiac troponin I immunoassays using patients and quality control plasma samples. On behalf of the Italian Section of the European Ligand Assay Society (ELAS) and of the Study Group on Cardiovascular Biomarkers of the Società Italiana di Biochimica Clinica (SIBioC). Clin Chim Acta 2016;456:42–8. Search in Google Scholar

8. Sigurdardottir FD, Lynbakken MN, Holmen OL, Dalen H, Hyeem K, Røsjø H, et al. Relative prognostic value of cardiac troponin I and C-reactive protein in the general population (from the North-Trøndelag Health [HUNT] Study. Am J Cardiol 2018;121:949–55. Search in Google Scholar

9. Giannoni A, Giovannini S, Clerico A. Measurement of circulating concentrations of cardiac troponin I and T in healthy subjects: a tool for monitoring myocardial tissue renewal? Clin Chem Lab Med 2009;47:1167–77. Search in Google Scholar

10. Marjot J, Kaier TE, Martin ED, Reji SS, Copeland O, Iqbal M, et al. Quantifying the release of biomarkers of myocardial necrosis from cardiac myocytes and intact myocardium. Clin Chem 2017;63:990–6. Search in Google Scholar

11. Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, et al. Fourth Universal Definition of Myocardial Infarction. J Am Coll Cardiol 2018;72:2231–64. Search in Google Scholar

Received: 2019-01-10
Accepted: 2019-02-15
Published Online: 2019-03-20
Published in Print: 2019-09-25

©2019 Walter de Gruyter GmbH, Berlin/Boston