The European Biological Variation Study (EuBIVAS): Weekly biological variation of cardiac troponin i estimated by the use of two different high-sensitivity cardiac troponin i assays

European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group on Biological Variation, Ferruccio Ceriotti, Jorge Díaz-Garzón Marco, Pilar Fernández-Calle, Alessio Maregnani, Aasne K. Aarsand, Abdurrahman Coskun, Niels Jonker, Sverre Sandberg, Anna Carobene

Research output: Contribution to journalArticlepeer-review

Abstract

Cardiac troponins (cTn) are specific markers for cardiac damage and acute coronary syndromes. The availability of new high-sensitivity assays allows cTn detection in healthy people, thus permitting the estimation of biological variation (BV) of cTn. The knowledge of BV is important to define analytical performance specifications (APS) and reference change values (RCVs). The aim of this study was to estimate the within-and between-subject weekly BV (CVI, CVG) of cTnI applying two high-sensitivity cTnI assays, using European Biological Variation Study (EuBIVAS) specimens. Thirty-eight men and 53 women underwent weekly fasting blood drawings for 10 consecutive weeks. Duplicate measurements were performed with Singulex Clarity (Singulex, USA) and Siemens Atellica (Siemens Healthineers, Germany). cTnI was measurable in 99.4% and 74.3% of the samples with Singulex and Atellica assays, respectively. Concentrations were significantly higher in men than in women with both methods. The CVI estimates with 95% confidence interval (CI) were for Singulex 16.6% (15.6-17.7) and for Atellica 13.8% (12.7-15.0), with the observed difference likely being caused by the different number of measurable samples. No significant CVI differences were observed between men and women. The CVG estimates for women were 40.3% and 36.3%, and for men 65.3% and 36.5% for Singulex and Atellica, respectively. The resulting APS and RCVs were similar for the two methods. This is the first study able to estimate cTnI BV for such a large cohort of well-characterized healthy individuals deriving objective APS and RCV values for detecting significant variations in cTnI serial measurements, even within the 99th percentile.

Original languageEnglish
Pages (from-to)1741-1747
JournalClinical Chemistry and Laboratory Medicine
Volume58
Issue number10
DOIs
Publication statusPublished - 2020

Keywords

  • analytical performance specifications
  • biological variation
  • high-sensitivity cardiac troponin I
  • reference change value

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical

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