1. Evaluation of 99th percentile and reference change values of the hs-cTnI method using ADVIA Centaur XPT platform: A multicenter study.
- Author
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Clerico, Aldo, Masotti, Silvia, Musetti, Veronica, Ripoli, Andrea, Aloe, Rosalia, Di Pietro, Martina, Rizzardi, Sara, Dittadi, Ruggero, Carrozza, Cinzia, Belloni, Lucia, Perrone, Marco, Fasano, Tommaso, Canovi, Simone, de Santis, Antonio, Prontera, Concetta, Guiotto, Cristina, Cosseddu, Domenico, Migliardi, Marco, and Bernardini, Sergio
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REFERENCE values , *PATHOLOGICAL laboratories , *TROPONIN I , *LOGNORMAL distribution , *PERCENTILES - Abstract
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. 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). 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). 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. • The 99th URL value is a very difficult task that is usually beyond the capacity of a single laboratory. • The Italian Societies SIBioC and ELAS have recently promoted a multicenter study to accurately evaluate analytical performances and reference values of the most popular cTnI methods commercially available in Italy. • cTnI reference distribution parameters were evaluated in a large population including healthy adults subjects, well matched for age and sex-ratio. • The ADVIA XPT method fits both the criteria and quality specifications required by the most recent international guidelines for high-sensitivity methods for cTnI assay. [ABSTRACT FROM AUTHOR]
- Published
- 2019
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