Abstract
Background: The Italian Society of Clinical Biochemistry (SIBioC) and the Italian Section of the European Ligand Assay Society (ELAS) have recently promoted a multicenter study (Italian hs-cTnI Study) with the aim to accurately evaluate analytical performances and reference values of the most popular cTnI methods commercially available in Italy. The aim of this article is to report the results of the Italian hs-cTnI Study concerning the evaluation of the 99th percentile URL and reference change (RCV) values around the 99th URL of the Access cTnI method. Materials and methods: Heparinized plasma samples were collected from 1306 healthy adult volunteers by 8 Italian clinical centers. Every center collected from 50 to 150 plasma samples from healthy adult subjects. All volunteers denied the presence of chronic or acute diseases and had normal values of routine laboratory tests (including creatinine, electrolytes, glucose and blood counts). An older cohort of 457 adult subjects (mean age 63.0 years; SD 8.1 years, minimum 47 years, maximum 86 years) underwent also ECG and cardiac imaging analysis in order to exclude the presence of asymptomatic cardiac disease. Results and conclusions: The results of the present study confirm that the Access hsTnI method using the DxI platform satisfies the two criteria required by international guidelines for high-sensitivity methods for cTn assay. Furthermore, the results of this study confirm that the calculation of the 99th percentile URL values are greatly affected not only by age and sex of the reference population, but also by the statistical approach used for calculation of cTnI distribution parameters.
| Original language | English |
|---|---|
| Pages (from-to) | 156-161 |
| Number of pages | 6 |
| Journal | Clinica Chimica Acta |
| Volume | 493 |
| DOIs | |
| Publication status | Published - Jun 1 2019 |
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Keywords
- Acute coronary syndrome
- Cardiac troponins
- High-sensitivity methods
- Myocardial infarction
- Reference population
- Risk stratification
ASJC Scopus subject areas
- Biochemistry
- Clinical Biochemistry
- Biochemistry, medical
Cite this
Evaluation of 99th percentile and reference change values of a high-sensitivity cTnI method : A multicenter study. / Clerico, Aldo; Ripoli, Andrea; Masotti, Silvia; Musetti, Veronica; Aloe, Rosalia; Dipalo, Mariella; Rizzardi, Sara; Dittadi, Ruggero; Carrozza, Cinzia; Storti, Simona; Belloni, Lucia; Perrone, Marco; Fasano, Tommaso; Canovi, Simone; Correale, Mario; Prontera, Concetta; Guiotto, Cristina; Cosseddu, Domenico; Migliardi, Marco; Bernardini, Sergio.
In: Clinica Chimica Acta, Vol. 493, 01.06.2019, p. 156-161.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Evaluation of 99th percentile and reference change values of a high-sensitivity cTnI method
T2 - A multicenter study
AU - Clerico, Aldo
AU - Ripoli, Andrea
AU - Masotti, Silvia
AU - Musetti, Veronica
AU - Aloe, Rosalia
AU - Dipalo, Mariella
AU - Rizzardi, Sara
AU - Dittadi, Ruggero
AU - Carrozza, Cinzia
AU - Storti, Simona
AU - Belloni, Lucia
AU - Perrone, Marco
AU - Fasano, Tommaso
AU - Canovi, Simone
AU - Correale, Mario
AU - Prontera, Concetta
AU - Guiotto, Cristina
AU - Cosseddu, Domenico
AU - Migliardi, Marco
AU - Bernardini, Sergio
PY - 2019/6/1
Y1 - 2019/6/1
N2 - Background: The Italian Society of Clinical Biochemistry (SIBioC) and the Italian Section of the European Ligand Assay Society (ELAS) have recently promoted a multicenter study (Italian hs-cTnI Study) with the aim to accurately evaluate analytical performances and reference values of the most popular cTnI methods commercially available in Italy. The aim of this article is to report the results of the Italian hs-cTnI Study concerning the evaluation of the 99th percentile URL and reference change (RCV) values around the 99th URL of the Access cTnI method. Materials and methods: Heparinized plasma samples were collected from 1306 healthy adult volunteers by 8 Italian clinical centers. Every center collected from 50 to 150 plasma samples from healthy adult subjects. All volunteers denied the presence of chronic or acute diseases and had normal values of routine laboratory tests (including creatinine, electrolytes, glucose and blood counts). An older cohort of 457 adult subjects (mean age 63.0 years; SD 8.1 years, minimum 47 years, maximum 86 years) underwent also ECG and cardiac imaging analysis in order to exclude the presence of asymptomatic cardiac disease. Results and conclusions: The results of the present study confirm that the Access hsTnI method using the DxI platform satisfies the two criteria required by international guidelines for high-sensitivity methods for cTn assay. Furthermore, the results of this study confirm that the calculation of the 99th percentile URL values are greatly affected not only by age and sex of the reference population, but also by the statistical approach used for calculation of cTnI distribution parameters.
AB - Background: The Italian Society of Clinical Biochemistry (SIBioC) and the Italian Section of the European Ligand Assay Society (ELAS) have recently promoted a multicenter study (Italian hs-cTnI Study) with the aim to accurately evaluate analytical performances and reference values of the most popular cTnI methods commercially available in Italy. The aim of this article is to report the results of the Italian hs-cTnI Study concerning the evaluation of the 99th percentile URL and reference change (RCV) values around the 99th URL of the Access cTnI method. Materials and methods: Heparinized plasma samples were collected from 1306 healthy adult volunteers by 8 Italian clinical centers. Every center collected from 50 to 150 plasma samples from healthy adult subjects. All volunteers denied the presence of chronic or acute diseases and had normal values of routine laboratory tests (including creatinine, electrolytes, glucose and blood counts). An older cohort of 457 adult subjects (mean age 63.0 years; SD 8.1 years, minimum 47 years, maximum 86 years) underwent also ECG and cardiac imaging analysis in order to exclude the presence of asymptomatic cardiac disease. Results and conclusions: The results of the present study confirm that the Access hsTnI method using the DxI platform satisfies the two criteria required by international guidelines for high-sensitivity methods for cTn assay. Furthermore, the results of this study confirm that the calculation of the 99th percentile URL values are greatly affected not only by age and sex of the reference population, but also by the statistical approach used for calculation of cTnI distribution parameters.
KW - Acute coronary syndrome
KW - Cardiac troponins
KW - High-sensitivity methods
KW - Myocardial infarction
KW - Reference population
KW - Risk stratification
UR - http://www.scopus.com/inward/record.url?scp=85062963507&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85062963507&partnerID=8YFLogxK
U2 - 10.1016/j.cca.2019.02.029
DO - 10.1016/j.cca.2019.02.029
M3 - Article
VL - 493
SP - 156
EP - 161
JO - Clinica Chimica Acta
JF - Clinica Chimica Acta
SN - 0009-8981
ER -