Sample matrix and high-sensitivity cardiac troponin i assays

Peter A. Kavsak, Chantele Roy, Paul Malinowski, Lorna Clark, Shana Lamers, Karen Bamford, Stephen Hill, Andrew Worster, Allan S Jaffe

Research output: Contribution to journalArticle

5 Scopus citations

Abstract

Manufacturers of high-sensitivity cardiac troponin (hs-cTn) assays have restricted use of what sample types or matrices are acceptable to use for measurement. Our goal was to evaluate the comparability of the Siemens ADVIA Centaur hs-cTnI assay across different matrices and under different storage conditions. Three different QC-plasma matrices were evaluated for imprecision <10 ng/L. Passing-Bablok regression and difference plots were determined for cTnI concentrations spanning the reference interval (limit of quantification to male 99th-percentile: 2.5 ng/L to <60 ng/L) between serum and lithium heparin plasma, lithium heparin and EDTA plasma and between the Siemens and Abbott hs-cTnI assays. Stability at room temperature (RT) and 2-8 °C was also assessed across the three matrices. Over 16-weeks the SDs were ≤1.0 ng/L for QCs ranging from 5.0 to 8.3 ng/L. Across the reference interval there was excellent agreement between lithium heparin plasma and serum for the Siemens hs-cTnI assay (slope=0.98/intercept=-0.1), however, cTnI concentrations were proportionally lower in EDTA as compared to lithium heparin plasma (slope=0.90, 95% CI: 0.88-0.92). In lithium heparin plasma the Siemens hs-cTnI concentrations were higher than the Abbott hs-cTnI concentrations (slope=1.26/intercept=-0.2). Stability of cTnI in lithium heparin plasma as compared in serum and EDTA plasma appeared more labile, with decreases ≥20% in concentrations evident as early as 1-day in storage at RT. There is excellent agreement in concentrations between lithium heparin plasma and serum with the Siemens ADVIA Centaur hs-cTnI assay; however, cTnI concentrations in EDTA plasma are lower. Reference intervals and clinical studies in EDTA plasma for the Centaur hs-cTnI assay are required before clinical use.

Original languageEnglish (US)
JournalClinical Chemistry and Laboratory Medicine
DOIs
StateAccepted/In press - Jan 1 2018

Keywords

  • analytical variation
  • EDTA plasma
  • high-sensitivity cardiac troponin
  • lithium heparin plasma
  • matrix
  • serum
  • stability

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical

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  • Cite this

    Kavsak, P. A., Roy, C., Malinowski, P., Clark, L., Lamers, S., Bamford, K., Hill, S., Worster, A., & Jaffe, A. S. (Accepted/In press). Sample matrix and high-sensitivity cardiac troponin i assays. Clinical Chemistry and Laboratory Medicine. https://doi.org/10.1515/cclm-2018-1100