Cardiac Troponin Assays: Guide to Understanding Analytical Characteristics and Their Impact on Clinical Care
Abstract
BACKGROUND: Cardiac troponin I (cTnI) and cardiac troponin T (cTnT) determinations are fixtures in clinical practice and research. Cardiac troponin testing has been the standard of practice for the diagnosis of acute myocardial infarction (AMI), early rule-out, risk stratification, and outcomes assessment in patients presenting with acute coronary syndrome (ACS) and non-ACS myocardial injury. We recognize from reading the literature over the past several years how poorly understood the analytical characteristics are for cTnI and cTnT assays by laboratorians, clinicians, and scientists who use these assays. CONTENT: The purposes of this mini-review are (a) to define limit of blank, limit of detection, limit of quantification, and imprecision, (b) overview the analytical characteristics of the existing cardiac troponin assays, (c) recommend approaches to define a healthy (normal) reference population for determining the 99th percentile and the appropriate statistic to use for this calculation, (d) clarify how an assay becomes designated as “high sensitivity,” and (e) provide guidance on determining delta (Δ) change values. SUMMARY: This review raises important educational information regarding cTnI and cTnT assays, their 99th percentile upper reference limits (URL) differentiated by sex, and specifically addresses high-sensitivity (hs)-assays used to measure low concentrations. Recommendations are made to help clarify the nomenclature and analytical and clinical characteristics to define hs-assays. The review also identifies challenges for the evolving implementation of hs-assays into clinical practice. It is hoped that with the introduction of these concepts, laboratorians, clinicians and researchers can develop a more unified view of how these assays should be used worldwide.
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The NP-Pep is capable of reproducibly and effectively enriching cTnI across all tested serum samples without the use of antibody.
“These serum cTnI enrichment results illustrate the major benefits of functionalized NPs compared to current antibody-based approaches: (1) NPs are capable of reproducibly and effectively enriching cTnI (Supplementary Fig. 23) across all tested serum samples without the use of antibody, thus overcoming the intrinsic antibody-related limitations (vide supra)14,15,51–53.”
From Nanoproteomics enables proteoform-resolved analysis of low-abundance proteins in human serum (2020) · cites this paper as [52]
The functionalized NPs possess unique advantages over antibody-based platforms: comparable size and diffusion kinetics to proteins, high surface area per volume and high number of flexible binding sites, and inexpensive, simple, fast, scalable synthesis with minimal batch-to-batch variability.
“These results highlight the unique advantages that these functionalized NPs possess for protein enrichment over antibody-based platforms: (a) comparable size and diffusion kinetics to proteins, promoting effective capture of low-abundance proteins within complex mixtures20,47,48; (b) high surface area per volume and high number of flexible binding sites, contributing to high ligand density and”
From Nanoproteomics enables proteoform-resolved analysis of low-abundance proteins in human serum (2020) · cites this paper as [52]
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Nanoproteomics enables proteoform-resolved analysis of low-abundance proteins in human serum
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- Authors
- Apple, F. S., Sandoval, Y., Jaffe, A. S., & Ordonez-Llanos, J.
- Affiliations
- University of Minnesota (US)
- Abbott Northwestern Hospital (US)
- Mayo Clinic (US)
- Servei Bioquimica, IBB-Hospital de la Santa Creu i Sant Pau and Department de Bioquimica i Biologia Molecular, Universitat Autònoma, Barcelona, Spain
- Corresponding author
- Apple, Fred S
- Venue
- Clinical Chemistry
- Publisher
- Oxford University Press (OUP)
- Published
- 2017-01-01
- Volume
- 63
- Issue
- 1
- Pages
- 73-81
- ISSN
- 0009-9147 (ISSN-L)
- 1530-8561
- OpenAlex
- W2530199167
- Cited by
- 408
- References
- 40
- Citations by year
- 2026: 34 · 2025: 39 · 2024: 38 · 2023: 43 · 2022: 41 · 2021: 44 · 2020: 47 · 2019: 49 · 2018: 37 · 2017: 35
- FWCI
- 7.04
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- Clinical Chemistry (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Roche Diagnostics and Singulex, Inc.
- Abbott Laboratories
- Siemens Healthcare
- Singulex
- Roche Diagnostics
- Beckman Coulter
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Cardiac Imaging and Diagnostics
- Keywords
- cardiac troponin I, cardiac troponin T, high-sensitivity troponin assays, analytical characteristics, detection limit, limit of quantification, assay imprecision, 99th percentile upper reference limit, reference population, acute myocardial infarction, acute coronary syndrome, myocardial injury, risk stratification
- MeSH terms
- Humans, Myocardial Infarction, Reperfusion Injury, Troponin I, Troponin T, Acute Coronary Syndrome
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