Evaluation of 99th percentile and reference change values of the hs-cTnI method using ADVIA Centaur XPT platform

A multicenter study

Aldo Clerico, Silvia Masotti, Veronica Musetti, Andrea Ripoli, Rosalia Aloe, Martina Di Pietro, Sara Rizzardi, Ruggero Dittadi, Cinzia Carrozza, Lucia Belloni, Marco Perrone, Tommaso Fasano, Simone Canovi, Antonio de Santis, Concetta Prontera, Cristina Guiotto, Domenico Cosseddu, Marco Migliardi, Sergio Bernardini

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)161-166
Number of pages6
JournalClinica Chimica Acta
Volume495
DOIs
Publication statusPublished - Aug 1 2019
Externally publishedYes

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Troponin I
Multicenter Studies
Websites
Reference Values
Clinical laboratories
Specifications
Normal distribution
Assays
Guidelines
Normal Distribution
Population
Healthy Volunteers

Keywords

  • Acute coronary syndrome
  • Cardiac troponins
  • Cardiovascular risk
  • High-sensitivity method
  • Myocardial injury
  • Reference changes values
  • Reference population

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Biochemistry, medical

Cite this

Evaluation of 99th percentile and reference change values of the hs-cTnI method using ADVIA Centaur XPT platform : A multicenter study. / 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; Bernardini, Sergio.

In: Clinica Chimica Acta, Vol. 495, 01.08.2019, p. 161-166.

Research output: Contribution to journalArticle

Clerico, A, Masotti, S, Musetti, V, Ripoli, A, Aloe, R, Di Pietro, M, Rizzardi, S, Dittadi, R, Carrozza, C, Belloni, L, Perrone, M, Fasano, T, Canovi, S, de Santis, A, Prontera, C, Guiotto, C, Cosseddu, D, Migliardi, M & Bernardini, S 2019, 'Evaluation of 99th percentile and reference change values of the hs-cTnI method using ADVIA Centaur XPT platform: A multicenter study', Clinica Chimica Acta, vol. 495, pp. 161-166. https://doi.org/10.1016/j.cca.2019.04.056
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 ; Bernardini, Sergio. / Evaluation of 99th percentile and reference change values of the hs-cTnI method using ADVIA Centaur XPT platform : A multicenter study. In: Clinica Chimica Acta. 2019 ; Vol. 495. pp. 161-166.
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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.",
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T2 - A multicenter study

AU - Clerico, Aldo

AU - Masotti, Silvia

AU - Musetti, Veronica

AU - Ripoli, Andrea

AU - Aloe, Rosalia

AU - Di Pietro, Martina

AU - Rizzardi, Sara

AU - Dittadi, Ruggero

AU - Carrozza, Cinzia

AU - Belloni, Lucia

AU - Perrone, Marco

AU - Fasano, Tommaso

AU - Canovi, Simone

AU - de Santis, Antonio

AU - Prontera, Concetta

AU - Guiotto, Cristina

AU - Cosseddu, Domenico

AU - Migliardi, Marco

AU - Bernardini, Sergio

PY - 2019/8/1

Y1 - 2019/8/1

N2 - 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.

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KW - Acute coronary syndrome

KW - Cardiac troponins

KW - Cardiovascular risk

KW - High-sensitivity method

KW - Myocardial injury

KW - Reference changes values

KW - Reference population

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