Analytical Characteristics of High-Sensitivity Cardiac Troponin Assays

Apple, Fred S; Collinson, Paul O; for the IFCC Task Force on Clinical Applications of Cardiac Biomarkers

doi:10.1373/clinchem.2011.165795

Cited by 861Acute Myocardial Infarction ResearchClinical Laboratory Practices and Quality ControlBiomarkers in Disease Mechanisms

Analytical Characteristics of High-Sensitivity Cardiac Troponin Assays

Apple, Fred S, Collinson, Paul O, for the IFCC Task Force on Clinical Applications of Cardiac Biomarkers·2012·Clinical Chemistry

DOI 10.1373/clinchem.2011.165795

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Abstract

BACKGROUND: Cardiac troponins I (cTnI) and T (cTnT) have received international endorsement as the standard biomarkers for detection of myocardial injury, for risk stratification in patients suspected of acute coronary syndrome, and for the diagnosis of myocardial infarction. An evidence-based clinical database is growing rapidly for high-sensitivity (hs) troponin assays. Thus, clarifications of the analytical principles for the immunoassays used in clinical practice are important. CONTENT: The purpose of this mini-review is (a) to provide a background for the biochemistry of cTnT and cTnI and (b) to address the following analytical questions for both hs cTnI and cTnT assays: (i) How does an assay become designated hs? (ii) How does one realistically define healthy (normal) reference populations for determining the 99th percentile? (iii) What is the usual biological variation of these analytes? (iv) What assay imprecision characteristics are acceptable? (v) Will standardization of cardiac troponin assays be attainable? SUMMARY: This review raises important points regarding cTnI and cTnT assays and their reference limits and specifically addresses hs assays used to measure low concentrations (nanograms per liter or picograms per milliliter). Recommendations are made to help clarify the nomenclature. The review also identifies further challenges for the evolving science of cardiac troponin measurement. It is hoped that with the introduction of these concepts, both laboratorians and clinicians can develop a more unified view of how these assays are used worldwide in clinical practice.

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The peptide targets the central portion of cTnI (amino acid residues 114-144) with less susceptibility to proteolysis.
“This specific peptide (HWQIAYNEHQWQ) not only exhibits an impressive binding affinity (Kd) of 270 pM comparable to that of antibodies37, but also targets the central portion of cTnI (amino acid residues 114–144) with less susceptibility to proteolysis and is postulated to be an optimal targeting epitope to detect all forms of cTnI present in blood circulation38–40.”
From Nanoproteomics enables proteoform-resolved analysis of low-abundance proteins in human serum (2020) · cites this paper as [40]

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Cardiac Troponin Assays: Guide to Understanding Analytical Characteristics and Their Impact on Clinical Care
Apple, F. S., Sandoval, Y., Jaffe, A. S., & Ordonez-Llanos, J. (2017) · Clinical Chemistry · doi:10.1373/clinchem.2016.255109 · Cited by 408 · see citing works
Self-citation
for the IFCC Task Force on Clinical Applications of Cardiac Biomarkers†
Assays, T., & Collinson, P. O. (2016)
Self-citation
Evaluation of analytical performance of immunoassay methods for cTnI and cTnT: From theory to practice
Clerico, A., Zaninotto, M., Padoan, A., Masotti, S., Musetti, V., Prontera, C., Ndreu, R., Zucchelli, G., Passino, C., Migliardi, M., et al. (2019) · Advances in clinical chemistry · doi:10.1016/bs.acc.2019.07.005 · Cited by 64 · see citing works
High-sensitivity cardiac troponin assays: Answers to frequently asked questions
Chenevier‐Gobeaux, C., Bonnefoy‐Cudraz, E., Charpentier, S., Dehoux, M., Lefèvre, G., Meune, C., & Ray, P. (2015) · Archives of cardiovascular diseases · doi:10.1016/j.acvd.2014.11.001 · Cited by 42 · see citing works
High-Sensitivity Cardiac Troponin Assays: What Analytical and Clinical Issues Need to Be Addressed before Introduction into Clinical Practice?
Apple, F. S. (2010) · Clinical Chemistry · doi:10.1373/clinchem.2009.138727 · Cited by 20 · see citing works
Self-citation

Authors: Apple, F. S., Collinson, P. O., & for the IFCC Task Force on Clinical Applications of Cardiac Biomarkers
Affiliations: University of Minnesota (US)
St George's Hospital (GB)
Corresponding author: Apple, Fred S
ORCID: Apple, Fred S
Collinson, Paul O
Venue: Clinical Chemistry
Publisher: Oxford University Press (OUP)
Published: 2012-01-01
Volume: 58
Issue: 1
Pages: 54-61
ISSN: 0009-9147 (ISSN-L)
1530-8561
DOI: 10.1373/clinchem.2011.165795
OpenAlex: W2151231511
Cited by: 861
References: 41
Citations by year: 2026: 26 · 2025: 39 · 2024: 33 · 2023: 42 · 2022: 44 · 2021: 51 · 2020: 53 · 2019: 58 · 2018: 63 · 2017: 87 · 2016: 88 · 2015: 69 · 2014: 75 · 2013: 81 · 2012: 46
FWCI: 11.14
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: Siemens
Abbott
Radiometer
B.R.A.H.M.S.
Roche
Alere
Instrumentation Laboratories
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
Life Sciences › Immunology and Microbiology › Immunology › Biomarkers in Disease Mechanisms
Keywords: high-sensitivity troponin I, high-sensitivity troponin T, cardiac troponin assays, assay standardization, reference limits, biological variation, assay imprecision, myocardial injury biomarkers, acute coronary syndrome, myocardial infarction diagnosis
MeSH terms: Humans, Immunoassay, Myocardial Infarction, Myocardium, Reference Values, Sensitivity and Specificity, Biomarkers, Troponin I, Troponin T, Acute Coronary Syndrome

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Analytical Characteristics of High-Sensitivity Cardiac Troponin Assays

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