Head-to-head comparison of plasma cTnI concentration values measured with three high-sensitivity methods in a large Italian population of healthy volunteers and patients admitted to emergency department with acute coronary syndrome: A multi-center study

Clerico, Aldo; Ripoli, Andrea; Zaninotto, Martina; Masotti, Silvia; Musetti, Veronica; Ciaccio, Marcello; Aloe, Rosalia; Rizzardi, Sara; Dittadi, Ruggero; Carrozza, Cinzia; Fasano, Tommaso; Perrone, Marco Alfonso; Santis, Antonio de; Prontera, Concetta; Riggio, Daniela; Guiotto, Cristina; Migliardi, Marco; Bernardini, Sergio; Plebani, Mario

doi:10.1016/j.cca.2019.06.012

Cited by 54 publications

(86 citation statements)

References 45 publications

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“…These assays revealed pronounced disparities in samples with increased cTn concentrations, thereby precluding an agreement in clinical classification of patients in the evaluated cohort by using respective 99th percentile URLs [14]. Similar results were more recently published by Clerico et al [15]. Studies on the biological variation of cTns have emphasized a very high individuality of these biomarkers, expressed as a low index of individuality, confirming major limitations for the use of population-based reference limits [16].…”

Section: The Post-analytical Phase: Improving Results' Interpretationsupporting

confidence: 78%

Laboratory-related issues in the measurement of cardiac troponins with highly sensitive assays

Krintus

Panteghini

2020

Clinical Chemistry and Laboratory Medicine (CCLM)

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A number of assay-related issues can affect the performance of cardiac troponin (cTn) measurement in everyday practice. In this respect, it is vital that all information on cTn assays is known and that the performance characteristics of assays are objectively assessed and adequately described. The advent of the latest generation of more sensitive cTn assays has heralded a new wave of information about low concentrations of cTn in blood. These recent generation assays have improved analytical sensitivity and corresponding performance at low cTn concentrations when compared to their predecessors, providing a convincing goal for laboratory medicine in helping clinicians in the diagnosis of acute myocardial infarction. Crucial to the clinical utility of highly sensitive cTn assays is the laboratorians’ role in closely scrutinizing proposed assays and defining their value in relation to available evidence. Analytical, as well as pre-analytical and post-analytical, aspects must be documented. In this review, we describe what laboratory professionals should know about their cTn assay performance characteristics and the pre-analytical prerequisites for robustness to ensure optimal post-analytical reporting.

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Section: The Post-analytical Phase: Improving Results' Interpretationsupporting

confidence: 78%

Laboratory-related issues in the measurement of cardiac troponins with highly sensitive assays

Krintus

Panteghini

2020

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…the cut-off value recommended by all the international guidelines for the diagnosis of MI) [54,55]. However, only after the year 2015 some high-sensitivity methods for cardiac troponins (hs-cTn) allowed a reliable determination of cTn distribution parameters in the most part of healthy subjects [56][57][58][59][60][61], in accordance with quality specifications required by the most recent international guidelines [54,55].…”

Section: Cardiac Troponin I and Tmentioning

confidence: 98%

“…Using these hs-cTn methods [56][57][58][59][60][61], more accurate risk stratification was finally achieved in large cohorts from the general population [48][49][50][62][63][64][65][66][67][68][69][70]. In particular, in 2017 Willeit et al [66] [66].…”

Section: Cardiac Troponin I and Tmentioning

confidence: 99%

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Evidence on clinical relevance of cardiovascular risk evaluation in the general population using cardio-specific biomarkers

Clerico

Zaninotto

Passino

et al. 2020

Clinical Chemistry and Laboratory Medicine (CCLM)

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In recent years, the formulation of some immunoassays with high-sensitivity analytical performance allowed the accurate measurement of cardiac troponin I (cTnI) and T (cTnT) levels in reference subjects. Several studies have demonstrated the association between the risk of major cardiovascular events and cardiac troponin concentrations even for biomarker values within the reference intervals. High-sensitivity cTnI and cTnT methods (hs-cTn) enable to monitor myocardial renewal and remodelling, and to promptly identify patients at highest risk ofheart failure. An early and effective treatment of individuals at higher cardiovascular risk may revert the initial myocardial remodelling and slow down heart failure progression. Specific clinical trials should be carried out to demonstrate the efficacy and efficiency of the general population screening by means of cost-benefit analysis, in order to better identify individuals at higher risk for Heart Failure (HF) progression with hs-cTn methods.

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“…From a pathophysiological perspective, it is important to underline that current hs-cTn methods have an analytical sensitivity ranging from about 1 to 3 ng/L (Table 1) [21][22][23][24][25][26][27]. Recent studies reported that these LoD values correspond to the amount of cTn contained in about 5 to 8 mg of cardiomyocytes [10,11,28,29].…”

Section: Cell Wounds Membranous Blebs Microparticlesmentioning

confidence: 99%

Cardiotoxic effects and myocardial injury: the search for a more precise definition of drug cardiotoxicity

Cardinale

Zaninotto

Cipolla

et al. 2020

Clinical Chemistry and Laboratory Medicine (CCLM)

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Drug-induced cardiotoxicity is a major clinical problem; cardiotoxic drugs may induce both cardiac dysfunction and myocardial injury. Several recent studies reported that cardiac troponins measured with high-sensitivity methods (hs-cTn) can enable the early detection of myocardial injury related to chemotherapy or abuse of drugs that are potentially cardiotoxic. Several authors have some concerns about the standard definition of cardiotoxicity, in particular, regarding the early evaluation of chemotherapy cardiotoxicity in cancer patients. Several recent studies using the hs-cTn assay indicate that myocardial injury may precede by some months or years the diagnosis of heart failure (HF) based on the evaluation of left ventricular ejection fraction (LVEF). Accordingly, hs-cTn assay should considered to be a reliable laboratory test for the early detection of asymptomatic or subclinical cardiotoxic damage in patients undergoing cancer chemotherapy. In accordance with the Fourth Universal Definition of Myocardial Infarction and also taking into account the recent experimental and clinical evidences, the definition of drug-cardiotoxicity should be updated considering the early evaluation of myocardial injury by means of hs-cTn assay. It is conceivable that the combined use of hs-cTn assay and cardiac imaging techniques for the evaluation of cardiotoxicity will significantly increase both diagnostic sensitivity and specificity, and also better prevent chemotherapy-related left ventricular (LV) dysfunction and other adverse cardiac events. However, large randomized clinical trials are needed to evaluate the cost/benefit ratio of standardized protocols for the early detection of cardiotoxicity using hs-cTn assay in patients receiving chemotherapy for malignant diseases.

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Head-to-head comparison of plasma cTnI concentration values measured with three high-sensitivity methods in a large Italian population of healthy volunteers and patients admitted to emergency department with acute coronary syndrome: A multi-center study

Cited by 54 publications

References 45 publications

Laboratory-related issues in the measurement of cardiac troponins with highly sensitive assays

Laboratory-related issues in the measurement of cardiac troponins with highly sensitive assays

Evidence on clinical relevance of cardiovascular risk evaluation in the general population using cardio-specific biomarkers

Cardiotoxic effects and myocardial injury: the search for a more precise definition of drug cardiotoxicity

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