Head-to-head comparison of plasma cTnI concentration values measured with three high-sensitivity methods in a large Italian population of healthy volunteers and patients admitted to emergency department with acute coronary syndrome: A multi-center study

Aldo Clerico, Andrea Ripoli, Martina Zaninotto, Silvia Masotti, Veronica Musetti, Marcello Ciaccio, Rosalia Aloe, Sara Rizzardi, Ruggero Dittadi, Cinzia Carrozza, Tommaso Fasano, Marco Perrone, Antonio de Santis, Concetta Prontera, Daniela Riggio, Cristina Guiotto, Marco Migliardi, Sergio Bernardini, Mario Plebani

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)25-34
Number of pages10
JournalClinica Chimica Acta
Volume496
DOIs
Publication statusPublished - Sep 1 2019

Fingerprint

Acute Coronary Syndrome
Hospital Emergency Service
Healthy Volunteers
Plasmas
Population
Websites
Assays
Principal component analysis
Reference Values
Acute Disease
Principal Component Analysis
Immunoassay
Multicenter Studies
Volunteers
Chronic Disease

Keywords

  • Acute coronary syndrome
  • Cardiac troponins
  • High-sensitivity methods
  • Myocardial infarction
  • Reference population values

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Biochemistry, medical

Cite this

Head-to-head comparison of plasma cTnI concentration values measured with three high-sensitivity methods in a large Italian population of healthy volunteers and patients admitted to emergency department with acute coronary syndrome : A multi-center study. / Clerico, Aldo; Ripoli, Andrea; Zaninotto, Martina; Masotti, Silvia; Musetti, Veronica; Ciaccio, Marcello; Aloe, Rosalia; Rizzardi, Sara; Dittadi, Ruggero; Carrozza, Cinzia; Fasano, Tommaso; Perrone, Marco; de Santis, Antonio; Prontera, Concetta; Riggio, Daniela; Guiotto, Cristina; Migliardi, Marco; Bernardini, Sergio; Plebani, Mario.

In: Clinica Chimica Acta, Vol. 496, 01.09.2019, p. 25-34.

Research output: Contribution to journalArticle

Clerico, A, Ripoli, A, Zaninotto, M, Masotti, S, Musetti, V, Ciaccio, M, Aloe, R, Rizzardi, S, Dittadi, R, Carrozza, C, Fasano, T, Perrone, M, de Santis, A, Prontera, C, Riggio, D, Guiotto, C, Migliardi, M, Bernardini, S & Plebani, M 2019, 'Head-to-head comparison of plasma cTnI concentration values measured with three high-sensitivity methods in a large Italian population of healthy volunteers and patients admitted to emergency department with acute coronary syndrome: A multi-center study', Clinica Chimica Acta, vol. 496, pp. 25-34. https://doi.org/10.1016/j.cca.2019.06.012
Clerico, Aldo ; Ripoli, Andrea ; Zaninotto, Martina ; Masotti, Silvia ; Musetti, Veronica ; Ciaccio, Marcello ; Aloe, Rosalia ; Rizzardi, Sara ; Dittadi, Ruggero ; Carrozza, Cinzia ; Fasano, Tommaso ; Perrone, Marco ; de Santis, Antonio ; Prontera, Concetta ; Riggio, Daniela ; Guiotto, Cristina ; Migliardi, Marco ; Bernardini, Sergio ; Plebani, Mario. / Head-to-head comparison of plasma cTnI concentration values measured with three high-sensitivity methods in a large Italian population of healthy volunteers and patients admitted to emergency department with acute coronary syndrome : A multi-center study. In: Clinica Chimica Acta. 2019 ; Vol. 496. pp. 25-34.
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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.",
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T1 - Head-to-head comparison of plasma cTnI concentration values measured with three high-sensitivity methods in a large Italian population of healthy volunteers and patients admitted to emergency department with acute coronary syndrome

T2 - A multi-center study

AU - Clerico, Aldo

AU - Ripoli, Andrea

AU - Zaninotto, Martina

AU - Masotti, Silvia

AU - Musetti, Veronica

AU - Ciaccio, Marcello

AU - Aloe, Rosalia

AU - Rizzardi, Sara

AU - Dittadi, Ruggero

AU - Carrozza, Cinzia

AU - Fasano, Tommaso

AU - Perrone, Marco

AU - de Santis, Antonio

AU - Prontera, Concetta

AU - Riggio, Daniela

AU - Guiotto, Cristina

AU - Migliardi, Marco

AU - Bernardini, Sergio

AU - Plebani, Mario

PY - 2019/9/1

Y1 - 2019/9/1

N2 - 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.

AB - 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.

KW - Acute coronary syndrome

KW - Cardiac troponins

KW - High-sensitivity methods

KW - Myocardial infarction

KW - Reference population values

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