Aldo Clerico1, Andrea Ripoli2, Silvia Masotti2, Veronica Musetti2, Rosalia Aloe3, Mariella Dipalo3, Sara Rizzardi4, Ruggero Dittadi5, Cinzia Carrozza6, Simona Storti2, Lucia Belloni7, Marco Perrone8, Tommaso Fasano7, Simone Canovi7, Mario Correale9, Concetta Prontera2, Cristina Guiotto10, Domenico Cosseddu10, Marco Migliardi10, Sergio Bernardini8. 1. Laboratorio Clinico, Fondazione CNR-Regione Toscana, G. Monasterio e Scuola Superiore Sant'Anna, Pisa, Italy. Electronic address: clerico@ifc.cnr.it. 2. Laboratorio Clinico, Fondazione CNR-Regione Toscana, G. Monasterio e Scuola Superiore Sant'Anna, Pisa, Italy. 3. S. S. Dipartimentale Biochimica ad Elevata Automazione, Dipartimento Diagnostico Azienda Ospedaliero-Universitaria di Parma, Parma, Italy. 4. Azienda Socio-Sanitaria Territoriale di Cremona, UO Laboratorio analisi chimico cliniche e microbiologiche, Cremona, Italy. 5. UOC Medicina di Laboratorio, Ospedale dell'Angelo ULSS 3 Serenissima, Mestre, Italy. 6. UOC Chimica, Biochimica e Biologia Molecolare Clinica, Fondazione Policlinico Universitario "A. Gemelli", IRCCS, and Università Cattolica del Sacro Cuore, Roma, Italy. 7. Laboratorio di Autoimmunità, Allergologia e Biotecnologie Innovative, Azienda Unità Sanitaria Locale, IRCCS and Laboratorio Analisi Chimico-Cliniche ed Endocrinologia-ASMN, Azienda Ospedaliera di Reggio Emilia, Italy. 8. Laboratorio Analisi Cliniche, Azienda Ospedaliera Universitaria Tor Vergata, Roma, Italy. 9. Unità di Patologia Clinica, IRCCS De Bellis, Castellana Grotte, e Laboratorio di Analisi Cliniche e Microbiologiche P.O. San Paolo - ASL Bari, Bari, Italy. 10. S.C. Laboratorio Analisi, A.O. Ordine Mauriziano di Torino, Torino, Italy.
Abstract
BACKGROUND: The Italian Society of Clinical Biochemistry (SIBioC) and the Italian Section of the European Ligand Assay Society (ELAS) have recently promoted a multicenter study (Italian hs-cTnI Study) with the aim to accurately evaluate analytical performances and reference values of the most popular cTnI methods commercially available in Italy. The aim of this article is to report the results of the Italian hs-cTnI Study concerning the evaluation of the 99th percentile URL and reference change (RCV) values around the 99th URL of the Access cTnI method. MATERIALS AND METHODS: Heparinized plasma samples were collected from 1306 healthy adult volunteers by 8 Italian clinical centers. Every center collected from 50 to 150 plasma samples from healthy adult subjects. All volunteers denied the presence of chronic or acute diseases and had normal values of routine laboratory tests (including creatinine, electrolytes, glucose and blood counts). An older cohort of 457 adult subjects (mean age 63.0 years; SD 8.1 years, minimum 47 years, maximum 86 years) underwent also ECG and cardiac imaging analysis in order to exclude the presence of asymptomatic cardiac disease. RESULTS AND CONCLUSIONS: The results of the present study confirm that the Access hsTnI method using the DxI platform satisfies the two criteria required by international guidelines for high-sensitivity methods for cTn assay. Furthermore, the results of this study confirm that the calculation of the 99th percentile URL values are greatly affected not only by age and sex of the reference population, but also by the statistical approach used for calculation of cTnI distribution parameters.
BACKGROUND: The Italian Society of Clinical Biochemistry (SIBioC) and the Italian Section of the European Ligand Assay Society (ELAS) have recently promoted a multicenter study (Italian hs-cTnI Study) with the aim to accurately evaluate analytical performances and reference values of the most popular cTnI methods commercially available in Italy. The aim of this article is to report the results of the Italian hs-cTnI Study concerning the evaluation of the 99th percentile URL and reference change (RCV) values around the 99th URL of the Access cTnI method. MATERIALS AND METHODS: Heparinized plasma samples were collected from 1306 healthy adult volunteers by 8 Italian clinical centers. Every center collected from 50 to 150 plasma samples from healthy adult subjects. All volunteers denied the presence of chronic or acute diseases and had normal values of routine laboratory tests (including creatinine, electrolytes, glucose and blood counts). An older cohort of 457 adult subjects (mean age 63.0 years; SD 8.1 years, minimum 47 years, maximum 86 years) underwent also ECG and cardiac imaging analysis in order to exclude the presence of asymptomatic cardiac disease. RESULTS AND CONCLUSIONS: The results of the present study confirm that the Access hsTnI method using the DxI platform satisfies the two criteria required by international guidelines for high-sensitivity methods for cTn assay. Furthermore, the results of this study confirm that the calculation of the 99th percentile URL values are greatly affected not only by age and sex of the reference population, but also by the statistical approach used for calculation of cTnI distribution parameters.