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Biological variation of cardiac myosin-binding protein C in healthy individuals

Research output: Contribution to journalArticlepeer-review

Bashir Alaour, Torbjørn Omland, Janniche Torsvik, Thomas E Kaier, Marit S Sylte, Heidi Strand, Jasmine Quraishi, Sam McGrath, Luke Williams, Steven Meex, Simon Redwood, Michael Marber, Kristin M Aakre

Original languageEnglish
JournalCLINICAL CHEMISTRY AND LABORATORY MEDICINE
Early online date23 Jun 2021
DOIs
Accepted/In press10 Jun 2021
E-pub ahead of print23 Jun 2021

Bibliographical note

Funding Information: Research funding: The study was supported by a grant from the British Heart Foundation (FS/18/78/33902), Guy’s and St Thomas’ Charity (London, UK; R060701, R100404), Department of Medical Biochemistry and Pharmacology, Haukeland University Hospital, and a grant from the University of Oslo. Publisher Copyright: © 2021 Walter de Gruyter GmbH, Berlin/Boston. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

King's Authors

Abstract

Cardiac myosin-binding protein C (cMyC) is a novel biomarker of myocardial injury, with a promising role in the triage and risk stratification of patients presenting with acute cardiac disease. In this study, we assess the weekly biological variation of cMyC, to examine its potential in monitoring chronic myocardial injury, and to suggest analytical quality specification for routine use of the test in clinical practice. Thirty healthy volunteers were included. Non-fasting samples were obtained once a week for ten consecutive weeks. Samples were tested in duplicate on the Erenna® platform by EMD Millipore Corporation. Outlying measurements and subjects were identified and excluded systematically, and homogeneity of analytical and within-subject variances was achieved before calculating the biological variability (CVI and CVG), reference change values (RCV) and index of individuality (II). Mean age was 38 (range, 21-64) years, and 16 participants were women (53%). The biological variation, RCV and II with 95% confidence interval (CI) were: CVA (%) 19.5 (17.8-21.6), CVI (%) 17.8 (14.8-21.0), CVG (%) 66.9 (50.4-109.9), RCV (%) 106.7 (96.6-120.1)/-51.6 (-54.6 to -49.1) and II 0.42 (0.29-0.56). There was a trend for women to have lower CVG. The calculated RCVs were comparable between genders. cMyC exhibits acceptable RCV and low II suggesting that it could be suitable for disease monitoring, risk stratification and prognostication if measured serially. Analytical quality specifications based on biological variation are similar to those for cardiac troponin and should be achievable at clinically relevant concentrations.

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