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Maria Stella Graziani

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Martina Zaninotto

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Davide Giavarina
Bruna Lo Sasso
Giampaolo Merlini
Martina Montagnana
Andrea Mosca
Paola Pezzati
Rossella Tomaiuolo
Matteo Vidali

International Advisory Board Khosrow Adeli Canada
Sergio Bernardini Italy
Marcello Ciaccio Italy
Eleftherios Diamandis Canada
Philippe Gillery France
Kjell Grankvist Sweden
Hans Jacobs The Netherlands
Eric Kilpatrick UK
Magdalena Krintus Poland
Giuseppe Lippi Italy
☩Howard Morris Australia
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Sverre Sandberg Norway
Ana-Maria Simundic Croatia
☩Jill Tate Australia
Tommaso Trenti Italy
Cas Weykamp The Netherlands
Maria Willrich USA
Paul Yip Canada


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Giuseppe Agosta

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Arianna Lucini Paioni
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email: biochimica.clinica@sibioc.it



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BC: Articoli scritti da C. Passino

Valutazione delle caratteristiche analitiche dei metodi di misura delle troponine cardiache I e T: dalla teoria alla pratica di laboratorio. Documento congiunto del Gruppo di Studio Biomarcatori Cardiovascolari di SIBioC-Medicina di Laboratorio ed Europea
Evaluation of analytical performance of immunoassay methods for cardiac troponin I and T: from theory to laboratory practice. Joint document of SIBioC and European Ligand Assay Society
<p>All the national and international guidelines recommend that cardiac troponins (cTnI and cTnT) should be considered the preferred biomarkers for the differential diagnosis of acute coronary syndrome (ACS), and also that the 99th upper reference population limit (URL) value for cardiac troponins should be measured with an imprecision &le;10 CV%. Indeed, the measurement of the 99th URL of cTnI and cTnT is a very hard analytical challenge due to low biomarker concentrations in healthy subjects. For this reason, only after the year 2006, some manufacturers set up the first new generation of cTnI and cTnT immunoassays with improved analytical sensitivity in accordance with the quality specifications indicated by international guidelines. The most recent international guidelines recommend that immunoassays for cTnI and cTnT measurement, able to completely satisfy these quality specifications, should be defined high-sensitivity methods. These methods should be preferred for early diagnosis of ACS syndrome and also for stratification of cardiovascular risk in both general population and cardiac patients. Therefore, understanding the analytical performance of immunoassay methods for cTnI and cTnT, especially at the low normal concentration range, is critically important for both laboratory professionals and clinicians. The aim of this document is to discuss some theoretical considerations related to the definition of analytical sensitivity, as well as some critical aspects concerning the experimental protocols commonly adopted for evaluation and comparison of analytical performances of cardiac troponin immunossays.</p>
Biochimica Clinica ; 42(2) 155-166
Documenti - Documents
 
Marcatori di rimodellamento e fibrosi cardiaca
Markers of cardiac remodeling and fibrosis
<p>Cardiac remodeling is considered the determinant of the clinical progression of heart failure. It is defined as a genome expression resulting in molecular, cellular and interstitial changes, clinically manifested as changes in size, shape and function of the heart. Ventricular remodeling occurs progressively in untreated patients after large myocardial infarction and in those with longstanding cardiomyopathy. Myocyte hypertrophy, cellular apoptosis and increased interstitial collagen deposition are the anatomopathological alterations leading to increased myocardial fibrosis. Myocardial hypertrophy and fibrosis increase left ventricular volume and induce perturbation in the left ventricular chamber geometry, leading to cardiac dysfunction. As a result, the assessment of cardiac fibrosis holds important clinical value in patients with heart failure. Accordingly, there is an increasing interest in the development of new markers for cardiac fibrosis and a number of laboratory tests have been recently proposed. The aim of the present article is to discuss analytical performances and clinical relevance of these markers.</p>
Biochimica Clinica ; 41(1) 023-038
Rassegne - Reviews
 
Analytical and clinical evaluation of the chemiluminescent microparticle immunoassay for galectin-3 determination
<p>This study tested if the chemiluminescent microparticle immunoassay (CMIA) method on the Architect platform meets the analytical and clinical quality goals required for the galectin-3 (GAL-3) use in clinical practice. We evaluated results obtained from 121 apparently healthy adults and 382 patients with heart failure (HF). All healthy subjects and patients showed GAL-3 concentrations in plasma above the limit of detection (1.9 &mu;g/L) and the limit of quantitation (2.4 &mu;g/L). GAL-3 in healthy subjects ranged between 6.4 and 40.6 &mu;g/L (median, 13.0 &mu;g/L, interquartile range, 11.2-15.2 &mu;g/L, 97.5th percentile, 33.7 &mu;g/L). GAL-3 values were found significantly increased in patients with chronic HF (median, 15.1 &mu;g/L, interquartile range, 11.7-19.4 &mu;g/L) compared to healthy subjects (P &lt;0.0001). HF patients with cardiac fibrosis, confirmed by magnetic resonance, showed significantly higher GAL-3 values (median, 15.3 &mu;g/L, interquartile range, 11.2-21.9 &mu;g/L) than those without cardiac fibrosis (median, 12.9 &mu;g/L, interquartile range, 11.2-15.0 &mu;g/L) (P=0.03). ROC analysis showed that GAL-3 discriminates the presence of cardiac fibrosis with an area under the curve of 0.635 (0.526-0.744), with a specificity of 76.7% and a sensitivity of 54.1% at the cut-off of 14.6 &mu;g/L. Using multivariable models cardiac fibrosis was significantly associated with the logGAL-3.</p>
Biochimica Clinica ; 40(4) 307-315
Contributi scientifici - Scientific Papers
 
La misura combinata dei biomarcatori cardio-specifici è utile nei pazienti con sospetto di malattie cardiovascolari
The combined measurement of cardio-specific biomarkers is a useful tool in patients with suspected cardiovascular disease
<p>A huge amount of experimental and clinical evidences clearly demonstrate that the measurement of cardio-specific biomarkers [cardiac natriuretic peptides (CNP), and cardiac troponins (cTns)] can significantly and independently improve the diagnostic accuracy and risk stratification in cardiovascular diseases. Furthermore, several recent studies report that the measurement of cardio-specific biomarkers has a beneficial impact also on management and outcome of patients with cardiovascular diseases. Considering the significant and independent information associated to cardio-specific biomarkers, several studies have recently reported that the combined assay of CNP and cTns may be cost effective not only for diagnosis, prognosis and treatment of cardiac disease, but also for screening in general population of individuals at high cardiovascular risk. Due to the higher cost of their measurement in comparison to other laboratory tests, the clinical appropriateness of the combined measurement of CNP and cTns should be accurately evaluated. Accordingly, an increase in clinical utilization of a laboratory test should be based not only on the peculiar pathophysiological characteristics of a biomarker, but also on the high performance of immunoassay methods used for the biomarker measurement. From a pathophysiological point of view, elevated CNP values indicate that some stressor substances or situations are having an adverse impact on cardiac function; while an increase in cTn levels above the cut-off value indicates that a sustained or powerful stress has actually produced a damage on cardiomyocytes (i.e. a myocardial injury). Consequently , the combined measurement of CNP and cTns gives complementary and distinct rather than redundant clinical information. These two distinct pathophysiological mechanisms also explain why cardiovascular risk is strongly increased in patients with both CNP and cTns elevated. In conclusions, the combined measurement of CNP and cTns is a useful tool for diagnosis, follow-up, and stratification of risk in all patients with suspected cardiac disease, especially those admitted to the emergence department.</p>
Biochimica Clinica ; 17(1)
Rassegne - Reviews
 
Valutazione del rischio cardiovascolare e del danno cardiaco asintomatico nella popolazione generale utilizzando la misura della troponina cardiaca con metodi ad alta sensibilità
Evaluation of cardiovascular risk and asymptomatic myocardial injury in the general population with high-sensitivity methods for cardiac troponin assay
<p>Only very recently the set-up of some immunoassay methods with high-sensitivity analytical performance allowed the accurate detection of cardiac troponin I (cTnI) and T (cTnT) levels in healthy adult 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 enable to monitor myocardial renewal and remodelling, and to promptly identify patients at highest risk to heart failure development. An early and effective treatment of individuals at higher cardiovascular risk may revert the initial myocardial remodelling and slow down heart failure progression. Dedicated trials are needed also in Italian population to demonstrate the efficiency of general population screening by means of cost benefit analysis for individuals at higher risk for heart failure progression.</p>
Biochimica Clinica ; 17(1)
Documenti SIBioC - SIBioC Documents