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Licensed Unlicensed Requires Authentication Published by De Gruyter January 10, 2019

Sample matrix and high-sensitivity cardiac troponin I assays

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

Abstract

Background

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.

Methods

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.

Results

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.

Conclusions

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.


Corresponding author: Dr. Peter A. Kavsak, McMaster University, Hamilton, ON, Canada; Core Laboratory, Hamilton Health Sciences, Hamilton, ON, Canada; and Juravinski Hospital and Cancer Centre, 711 Concession Street, Hamilton, ON L8V 1C3, Canada, Phone: +905-521-2100

Acknowledgments

Siemens Healthcare Diagnostics for the supplies and funding to perform this study.

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: Dr. Kavsak has received grants/reagents/consultant/advisor/honoraria from Abbott Laboratories, Abbott Point of Care, Abbott Diagnostics Division Canada, Beckman Coulter, Ortho Clinical Diagnostics, Randox Laboratories, Roche Diagnostics and Siemens Healthcare Diagnostics.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Conflict of interests: McMaster University has filed patents with Dr. Kavsak listed as an inventor in the acute cardiovascular biomarker field. Dr. Jaffe has consulted for majority of companies who manufacture cardiac troponin assays, including Siemens Healthcare Diagnostics. This analytical study was funded by Siemens Healthcare Diagnostics.

  6. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Received: 2018-10-09
Accepted: 2018-11-30
Published Online: 2019-01-10
Published in Print: 2019-04-24

©2019 Walter de Gruyter GmbH, Berlin/Boston

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