Aldo Clerico1, Silvia Masotti2, Veronica Musetti2, Andrea Ripoli2, Rosalia Aloe3, Martina Di Pietro3, Sara Rizzardi4, Ruggero Dittadi5, Cinzia Carrozza6, Lucia Belloni7, Marco Perrone8, Tommaso Fasano7, Simone Canovi7, Antonio de Santis9, 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. Laboratorio Analisi Chimico Cliniche e Microbiologiche - ASST di Cremona, 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 and Laboratorio Analisi Chimico-Cliniche ed Endocrinologia, Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Italy. 8. Dipartimento di Medicina Sperimentale, Università di Roma Tor Vergata, Roma, Italy. 9. 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: According to quality specifications required by international guidelines, the evaluation of the 99th URL value is a very difficult task that is usually beyond the capacity of a single laboratory. The aims of this article are to report and discuss the results of a multicenter study concerning the evaluation of the 99th percentile URL and reference change (RCV) of the ADVIA Centaur High-Sensitivity Troponin I (TNIH), recently distributed to the Italian clinical laboratories. MATERIALS AND METHODS: The reference population evaluated with ADVIA XPT method for the calculation of cTnI reference distribution parameters consisted of 1325 healthy adults subjects (age range from 18 to 86 years), including 653 women (mean age 50.7 years, SD 14.5 years) and 672 men (mean age 50.9 years, SD 13.8 years), well matched for both age (P = .8112) and sex (F/M = 0.97). RESULTS: cTnI distribution values of reference population was highly skewed, while log-transformed cTnI values roughly approximated a log-normal distribution. Men have higher cTnI values than women throughout all the adult lifespan. Moreover, the subjects with age ≤ 55 years had significantly lower cTnI values than those with age > 55 years (p < .0001). Of note, 62% of women and 77% of men had equal or higher than cTnI values than the LoD value of the method (i.e., 2.2 ng/L). CONCLUSIONS: The results of the present study demonstrate that the ADVIA Centaur High-Sensitivity Troponin I using the XPT automated platform fits both the criteria and quality specifications required by the most recent international guidelines for high-sensitivity methods for cTnI assay.
BACKGROUND: According to quality specifications required by international guidelines, the evaluation of the 99th URL value is a very difficult task that is usually beyond the capacity of a single laboratory. The aims of this article are to report and discuss the results of a multicenter study concerning the evaluation of the 99th percentile URL and reference change (RCV) of the ADVIA Centaur High-Sensitivity Troponin I (TNIH), recently distributed to the Italian clinical laboratories. MATERIALS AND METHODS: The reference population evaluated with ADVIA XPT method for the calculation of cTnI reference distribution parameters consisted of 1325 healthy adults subjects (age range from 18 to 86 years), including 653 women (mean age 50.7 years, SD 14.5 years) and 672 men (mean age 50.9 years, SD 13.8 years), well matched for both age (P = .8112) and sex (F/M = 0.97). RESULTS:cTnI distribution values of reference population was highly skewed, while log-transformed cTnI values roughly approximated a log-normal distribution. Men have higher cTnI values than women throughout all the adult lifespan. Moreover, the subjects with age ≤ 55 years had significantly lower cTnI values than those with age > 55 years (p < .0001). Of note, 62% of women and 77% of men had equal or higher than cTnI values than the LoD value of the method (i.e., 2.2 ng/L). CONCLUSIONS: The results of the present study demonstrate that the ADVIA Centaur High-Sensitivity Troponin I using the XPT automated platform fits both the criteria and quality specifications required by the most recent international guidelines for high-sensitivity methods for cTnI assay.