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

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

Research output: Contribution to journalArticle

25 Citations (Scopus)

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 - 2019

Keywords

  • Acute coronary syndrome
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Article
  • Blood Chemical Analysis
  • Cardiac troponins
  • Emergency Service, Hospital
  • Female
  • Healthy Volunteers
  • High-sensitivity methods
  • Humans
  • Italy
  • Limit of Detection
  • Male
  • Middle Aged
  • Myocardial infarction
  • Myocardium
  • Patient Admission
  • Reference Values
  • Reference population values
  • Troponin I
  • Young Adult
  • acute coronary syndrome
  • adolescent
  • adult
  • age
  • aged
  • blood
  • blood analysis
  • cardiac muscle
  • cardiac troponin 1 CLIA
  • clinical trial
  • comparative study
  • controlled study
  • diagnostic test accuracy study
  • emergency ward
  • female
  • heart infarction
  • heparinization
  • hospital admission
  • hospital emergency service
  • human
  • limit of detection
  • major clinical study
  • male
  • metabolism
  • middle aged
  • multicenter study
  • normal human
  • principal component analysis
  • priority journal
  • procedures
  • protein blood level
  • reference value
  • sex
  • troponin I
  • troponin I, acute coronary syndrome
  • very elderly
  • young adult, Acute Coronary Syndrome

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