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 language | English |
|---|---|
| Pages (from-to) | 25-34 |
| Number of pages | 10 |
| Journal | Clinica Chimica Acta |
| Volume | 496 |
| DOIs | |
| Publication status | Published - Sep 1 2019 |
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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 journal › Article
}
TY - JOUR
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
UR - http://www.scopus.com/inward/record.url?scp=85067598472&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85067598472&partnerID=8YFLogxK
U2 - 10.1016/j.cca.2019.06.012
DO - 10.1016/j.cca.2019.06.012
M3 - Article
AN - SCOPUS:85067598472
VL - 496
SP - 25
EP - 34
JO - Clinica Chimica Acta
JF - Clinica Chimica Acta
SN - 0009-8981
ER -