Evaluation of 99th percentile and reference change values of a high-sensitivity cTnI method: A multicenter study

Aldo Clerico, Andrea Ripoli, Silvia Masotti, Veronica Musetti, Rosalia Aloe, Mariella Dipalo, Sara Rizzardi, Ruggero Dittadi, Cinzia Carrozza, Simona Storti, Lucia Belloni, Marco Perrone, Tommaso Fasano, Simone Canovi, Mario Correale, Concetta Prontera, Cristina Guiotto, Domenico Cosseddu, Marco Migliardi, Sergio Bernardini

Research output: Contribution to journalArticle

5 Citations (Scopus)

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 languageEnglish
Pages (from-to)156-161
Number of pages6
JournalClinica Chimica Acta
Volume493
DOIs
Publication statusPublished - Jun 1 2019

Fingerprint

Multicenter Studies
Websites
Reference Values
Assays
Plasmas
Biochemistry
Electrocardiography
Healthy Volunteers
Electrolytes
Blood Glucose
Creatinine
Asymptomatic Diseases
Ligands
Imaging techniques
Acute Disease
Italy
Volunteers
Heart Diseases
Chronic Disease
Guidelines

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

Clerico, A., Ripoli, A., Masotti, S., Musetti, V., Aloe, R., Dipalo, M., ... Bernardini, S. (2019). Evaluation of 99th percentile and reference change values of a high-sensitivity cTnI method: A multicenter study. Clinica Chimica Acta, 493, 156-161. https://doi.org/10.1016/j.cca.2019.02.029

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 journalArticle

Clerico, A, Ripoli, A, Masotti, S, Musetti, V, Aloe, R, Dipalo, M, Rizzardi, S, Dittadi, R, Carrozza, C, Storti, S, Belloni, L, Perrone, M, Fasano, T, Canovi, S, Correale, M, Prontera, C, Guiotto, C, Cosseddu, D, Migliardi, M & Bernardini, S 2019, 'Evaluation of 99th percentile and reference change values of a high-sensitivity cTnI method: A multicenter study', Clinica Chimica Acta, vol. 493, pp. 156-161. https://doi.org/10.1016/j.cca.2019.02.029
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. / Evaluation of 99th percentile and reference change values of a high-sensitivity cTnI method : A multicenter study. In: Clinica Chimica Acta. 2019 ; Vol. 493. pp. 156-161.
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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.

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KW - Acute coronary syndrome

KW - Cardiac troponins

KW - High-sensitivity methods

KW - Myocardial infarction

KW - Reference population

KW - Risk stratification

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