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Lower Limits for Reporting High-Sensitivity Cardiac Troponin Assays and Impact of Analytical Performance on Patient Misclassification.

Aakre, KM; Apple, FS; Mills, NL; Meex, SJR; Collinson, PO; International Federation of Clinical Chemistry Committee on Clin (2024) Lower Limits for Reporting High-Sensitivity Cardiac Troponin Assays and Impact of Analytical Performance on Patient Misclassification. Clin Chem, 70 (3). pp. 497-505. ISSN 1530-8561 https://doi.org/10.1093/clinchem/hvad185
SGUL Authors: Collinson, Paul

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Abstract

BACKGROUND: Cardiac troponin measurements are indispensable for the diagnosis of myocardial infarction and provide useful information for long-term risk prediction of cardiovascular disease. Accelerated diagnostic pathways prevent unnecessary hospital admission, but require reporting cardiac troponin concentrations at low concentrations that are sometimes below the limit of quantification. Whether analytical imprecision at these concentrations contributes to misclassification of patients is debated. CONTENT: The International Federation of Clinical Chemistry Committee on Clinical Application of Cardiac Bio-Markers (IFCC C-CB) provides evidence-based educational statements on analytical and clinical aspects of cardiac biomarkers. This mini-review discusses how the reporting of low concentrations of cardiac troponins impacts on whether or not assays are classified as high-sensitivity and how analytical performance at low concentrations influences the utility of troponins in accelerated diagnostic pathways. Practical suggestions are made for laboratories regarding analytical quality assessment of cardiac troponin results at low cutoffs, with a particular focus on accelerated diagnostic pathways. The review also discusses how future use of cardiac troponins for long-term prediction or management of cardiovascular disease may require improvements in analytical quality. SUMMARY: Clinical guidelines recommend using cardiac troponin concentrations as low as the limit of detection of the assay to guide patient care. Laboratories, manufacturers, researchers, and external quality assessment providers should extend analytical performance monitoring of cardiac troponin assays to include the concentration ranges applicable in these pathways.

Item Type: Article
Additional Information: © The Author(s) 2023. Published by Oxford University Press on behalf of Association for Diagnostics & Laboratory Medicine. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
Keywords: International Federation of Clinical Chemistry Committee on Clinical Applications of Cardiac Biomarkers (IFCC C-CB), 1004 Medical Biotechnology, 1101 Medical Biochemistry and Metabolomics, 1103 Clinical Sciences, General Clinical Medicine
SGUL Research Institute / Research Centre: Academic Structure > Molecular and Clinical Sciences Research Institute (MCS)
Journal or Publication Title: Clin Chem
ISSN: 1530-8561
Language: eng
Dates:
DateEvent
March 2024Published
15 December 2023Published Online
27 September 2023Accepted
Publisher License: Creative Commons: Attribution 4.0
PubMed ID: 38102065
Web of Science ID: WOS:001124966600001
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/116035
Publisher's version: https://doi.org/10.1093/clinchem/hvad185

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