Aldo Clerico1, Andrea Ripoli2, Martina Zaninotto3, Silvia Masotti2, Veronica Musetti2, Marcello Ciaccio4, Rosalia Aloe5, Sara Rizzardi6, Ruggero Dittadi7, Cinzia Carrozza8, Tommaso Fasano9, Marco Perrone10, Antonio de Santis11, Concetta Prontera2, Daniela Riggio12, Cristina Guiotto13, Marco Migliardi13, Sergio Bernardini10, Mario Plebani3. 1. Laboratorio Clinico, Fondazione CNR-Regione Toscana, G. Monasterio e Scuola Superiore Sant'Anna, Pisa, Italy. Electronic address: clerico@ftgm.it. 2. Laboratorio Clinico, Fondazione CNR-Regione Toscana, G. Monasterio e Scuola Superiore Sant'Anna, Pisa, Italy. 3. Department of Laboratory Medicine, University-Hospital, Padova, Italy. 4. Department of Laboratory Medicine, University-Hospital, Palermo, Italy. 5. S. S. Dipartimentale Biochimica ad Elevata Automazione, Dipartimento Diagnostico Azienda Ospedaliero-Universitaria di Parma, Parma, Italy. 6. Azienda Socio-Sanitaria Territoriale di Cremona, UO Laboratorio analisi chimico cliniche e microbiologiche, Cremona, Italy. 7. Ospedale dell'Angelo ULSS 3 Serenissima, Mestre, Italy. 8. UOC Chimica, Biochimica e Biologia Molecolare Clinica, Fondazione Policlinico Universitario "A. Gemelli", IRCCS, and Università Cattolica del Sacro Cuore, Roma, Italy. 9. Laboratorio Analisi Chimico-Cliniche ed Endocrinologia (LACCE), Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Italy. 10. Università degli Studi Di Roma Tor Vergata, Dipartimento di Medicina, Roma, Italy. 11. Laboratorio di Analisi Cliniche e Microbiologiche P.O. San Paolo - ASL Bari, Bari, Italy. 12. Centro Cardiologico Monzino IRCCS, Milan, Italy. 13. S.C. Laboratorio Analisi, A.O. Ordine Mauriziano di Torino, Torino, Italy.
Abstract
BACKGROUND: The 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. METHODS: Heparinized 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. RESULTS: On 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). CONCLUSIONS: Due 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.
BACKGROUND: The 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. METHODS: Heparinized 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. RESULTS: On 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). CONCLUSIONS: Due 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.
Authors: Marco Alfonso Perrone; Alberto Aimo; Sergio Bernardini; Aldo Clerico Journal: Int J Environ Res Public Health Date: 2022-04-24 Impact factor: 4.614
Authors: Wouter C Meijers; Antoni Bayes-Genis; Alexandre Mebazaa; Johann Bauersachs; John G F Cleland; Andrew J S Coats; James L Januzzi; Alan S Maisel; Kenneth McDonald; Thomas Mueller; A Mark Richards; Petar Seferovic; Christian Mueller; Rudolf A de Boer Journal: Eur J Heart Fail Date: 2021-10-10 Impact factor: 17.349