High-sensitivity cardiac troponin I in the general population – defining reference populations for the determination of the 99th percentile in the Gutenberg Health Study
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Tanja Zeller
, Francisco Ojeda
Abstract
Background: The 99th percentile of cardiac troponin levels, determined in a reference population, is accepted as threshold for diagnosis of acute myocardial infarction (AMI). However, there is no common consensus of how to define the reference population. The aim of the present study was to determine 99th percentile reference values, determined by a high-sensitivity assay (hsTnI), according to different health status and cardiovascular risk factor prevalence in a large population-based sample.
Methods: Troponin I was determined using the Abbott ARCHITECT STAT highly sensitive troponin I immunoassay in 4138 participants of the Gutenberg Health Study.
Results: hsTnI was detectable in 81.6% of all individuals. The 99th percentile of the overall population was 27 ng/L. Age and gender had a prominent influence on these values. Exclusion of individuals with elevated natriuretic peptide levels or cardiac abnormalities resulted in lower 99th percentile values, whereas exclusion of individuals with an impaired estimated glomerular filtration rate (eGFR) or with prevalent coronary artery disease/myocardial infarction (CAD/MI) did not result in a meaningful change.
Conclusions: Troponin I, measured by a high-sensitivity assay, can be reliably detected in the vast majority of the general population. hsTnI values were dependent on age, gender as well as structural and functional cardiac abnormalities.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Financial support: Abbott Diagnostics provided test reagents for high-sensitive troponin I determinations within the frame of the Gutenberg Health Study. This work has been supported by the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement No. HEALTH-F2-2011-278913 (BiomarCaRE). Stefan Blankenberg has received honoraria from Abbott Diagnostics, Siemens, Brahms/Thermo Fisher, and Roche Diagnostics and is a consultant for Thermo Fisher.
Employment or leadership: None declared.
Honorarium: Karl J. Lackner has received honorari from Abbott Diagnostics, Siemens and bioMérieux.
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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Supplemental Material
The online version of this article (DOI: 10.1515/cclm-2014-0619) offers supplementary material, available to authorized users.
©2015 by De Gruyter
Articles in the same Issue
- Frontmatter
- Editorial
- High-sensitivity assays for cardiac troponins
- Reviews
- High sensitivity cardiac troponin assays in the clinical laboratories
- Laboratory medicine as the science that underpins medicine: the “high-sensitivity” troponin paradigm
- Cardiac troponin assays: a review of quantitative point-of-care devices and their efficacy in the diagnosis of myocardial infarction
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- Evaluation of standardization capability of current cardiac troponin I assays by a correlation study: results of an IFCC pilot project
- Estimation of age- and comorbidities-adjusted percentiles of high-sensitivity cardiac troponin T levels in the elderly
- High-sensitivity cardiac troponin I in the general population – defining reference populations for the determination of the 99th percentile in the Gutenberg Health Study
- Kinetics of high-sensitivity cardiac troponin T or troponin I compared to creatine kinase in patients with revascularized acute myocardial infarction
- Biological variation of high sensitivity cardiac troponin-T in stable dialysis patients: implications for clinical practice
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- Letters to the Editors
- Serum high-sensitivity troponin concentrations in a multi-ethnic Asian population of stable chronic kidney disease patients
- Comparison between BNP values measured in capillary blood samples with a POCT method and those measured in plasma venous samples with an automated platform
- Reply to the article entitled “Impact of assay design on test performance: lessons learned from 25-hydroxyvitamin D” by Farrell et al., Clin Chem Lab Med 2014;52:1579–87
- Reply. Impact of assay design on test performance: lessons learned from 25-hydroxyvitamin D. Authors’ response to the Letter to the Editor by Donnelly et al.
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Articles in the same Issue
- Frontmatter
- Editorial
- High-sensitivity assays for cardiac troponins
- Reviews
- High sensitivity cardiac troponin assays in the clinical laboratories
- Laboratory medicine as the science that underpins medicine: the “high-sensitivity” troponin paradigm
- Cardiac troponin assays: a review of quantitative point-of-care devices and their efficacy in the diagnosis of myocardial infarction
- Cardiovascular Diseases
- Evaluation of standardization capability of current cardiac troponin I assays by a correlation study: results of an IFCC pilot project
- Estimation of age- and comorbidities-adjusted percentiles of high-sensitivity cardiac troponin T levels in the elderly
- High-sensitivity cardiac troponin I in the general population – defining reference populations for the determination of the 99th percentile in the Gutenberg Health Study
- Kinetics of high-sensitivity cardiac troponin T or troponin I compared to creatine kinase in patients with revascularized acute myocardial infarction
- Biological variation of high sensitivity cardiac troponin-T in stable dialysis patients: implications for clinical practice
- Diagnosis of acute myocardial infarction in patients with renal insufficiency using high-sensitivity troponin T
- General Clinical Chemistry and Laboratory Medicine
- Active intervention in hospital test request panels pays
- An approach to establish the uncertainty budget of catalytic activity concentration measurements in a reference laboratory
- Uric acid: a potential biomarker of multiple sclerosis and of its disability
- Experience with the first fully automated chemiluminescence immunoassay for the quantification of 1α, 25-dihydroxy-vitamin D
- I-FABP and L-FABP are early markers for abdominal injury with limited prognostic value for secondary organ failures in the post-traumatic course
- Quantification of piperacillin, tazobactam, cefepime, meropenem, ciprofloxacin and linezolid in serum using an isotope dilution UHPLC-MS/MS method with semi-automated sample preparation
- Plasma visfatin/nicotinamide phosphoribosyltransferase (visfatin/NAMPT) concentration is not related to kidney function in elderly subjects
- Diagnostic performance study of an antigen microarray for the detection of antiphospholipid antibodies in human serum
- Dry ice exposure of plasma samples influences pH and lupus anticoagulant analysis
- Reference Values and Biological Variations
- A new robust statistical model for interpretation of differences in serial test results from an individual
- Cancer Diagnostics
- The value of red blood cell distribution width in endometrial cancer
- Letters to the Editors
- Serum high-sensitivity troponin concentrations in a multi-ethnic Asian population of stable chronic kidney disease patients
- Comparison between BNP values measured in capillary blood samples with a POCT method and those measured in plasma venous samples with an automated platform
- Reply to the article entitled “Impact of assay design on test performance: lessons learned from 25-hydroxyvitamin D” by Farrell et al., Clin Chem Lab Med 2014;52:1579–87
- Reply. Impact of assay design on test performance: lessons learned from 25-hydroxyvitamin D. Authors’ response to the Letter to the Editor by Donnelly et al.
- Therapeutic drug monitoring of voriconazole: validation of a novel ARK™ immunoassay and comparison with ultra-high performance liquid chromatography
- Interference of C-reactive protein with clotting times