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Editor-in-chief
Maria Stella Graziani

Deputy Director
Martina Zaninotto

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

EIC Assistant
Francesco Busardò

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
Mario Plebani Italy
Sverre Sandberg Norway
Ana-Maria Simundic Croatia
Tommaso Trenti Italy
Cas Weykamp The Netherlands
Maria Willrich USA
Paul Yip Canada


Publisher
Biomedia srl
Via L. Temolo 4, 20126 Milano

Responsible Editor
Giuseppe Agosta

Editorial Secretary
Chiara Riva
Biomedia srl
Via L. Temolo 4, 20126 Milano
Tel. 0245498282
email: biochimica.clinica@sibioc.it

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ISSN print: 0393 – 0564
ISSN digital: 0392- 7091



BC: Articoli scritti da A. Clerico

Variability of cardiac troponin levels in normal subjects and in patients with cardiovascular diseases: analytical considerations and clinical relevance. A consensus document by the Study Group on Cardiac Biomarkers from Italian Society of Biochemical Chemistry (SIBioC) and European Ligand Assay Society (ELAS)
<p><span style="font-family:arialmt,sans-serif; font-size:9.0pt">In accordance with all the most recent international guidelines, the variation of circulating levels of cardiac troponins I and T, measured with high-sensitivity methods (hs-cTnI and hs-cTnT), should be used for the detection of acute myocardial injury. Recent experimental and clinical evidences have demonstrated that the evaluation of hs-cTnI an hs-cTnT variations is particularly relevant: for the differential diagnosis of Acute Coronary Syndromes in patients admitted to the Emergency Department (ED); for the evaluation of cardiovascular risk in patients undergoing major cardiac or non-cardiac surgery, and in asymptomatic subjects of the general population aged &gt;55 years and with comorbidities; for the evaluation of cardiotoxicity caused by administration of some chemotherapy drugs in patients with malignant tumors. The aim of this document is to discuss the fundamental statistical and biological considerations on the intraindividual variability of hs-cTnI and hs-cTnT over time in the same individual. Firstly, it will be discussed in detail as the variations of circulating levels strictly depend not only on the analytical error of the method used but also on the intra-individual variability of the biomarker. Afterwards, the pathophysiological interpretation and the clinical relevance of the determination of the variability of the hs-cTnI and hs-cTnT values in patients with specific clinical conditions are discussed. Finally, the evaluation over time of the variation in circulating levels of hs-cTnI and hs-cTnT is proposed for a more accurate estimation of cardiovascular risk in asymptomatic subjects from the general population.</span></p>
Biochimica Clinica ; 47(1) 097-117
Documenti SIBioC - SIBioC Documents
 
Evaluation of the cardiovascular risk in patients undergoing major non-cardiac surgery: role of cardiac-specific biomarkers
Evaluation of the cardiovascular risk in patients undergoing major non-cardiac surgery: role of cardiac-specific biomarkers
<p>Cardiovascular risk evaluation in patients undergoing major non-cardiac surgery: role of cardiac-specific biomarkers.</p><p>Joint document of the Italian Societies of Clinical Biochemistry: European Ligand Assay Society, Sezione Italiana (ELAS), Societ&agrave; Italiana di Biochimica Clinica e Biologia Molecolare Clinica (SIBioC), Societ&agrave; Italiana di Patologia Clinica e Medicina di Laboratorio (SIPMeL) Patients undergoing major surgery have a substantial risk of cardiovascular events during the perioperative period.</p><p>Despite the introduction of several risk scores based on medical history, classical risk factors and non-invasive cardiac tests, the possibility to predict cardiovascular events in patients undergoing non-cardiac surgery remains limited. The cardiac-specific biomarkers natriuretic peptides (NPs) and cardiac troponins (cTn) have been proposed as additional tools for risk prediction in the peri-operative period. This Consensus Document aims to discuss the value of preoperative levels and perioperative changes in cardiac-specific biomarkers to predict adverse outcomes in patients undergoing major non-cardiac surgery. Based on several prospective observational studies and 6 meta-analyses, some guidelines recommended the measurement of NPs to refine perioperative cardiac risk estimation in patients undergoing noncardiac surgery. More recently, several studies reported a higher mortality in surgical patients presenting an elevation in high-sensitivity cTnT and cTnI, especially in elderly patients or those with comorbidities. This evidence should be considered in future international guidelines on the evaluation of perioperative risk in patients undergoing major noncardiac surgery.</p>
Biochimica Clinica ; 46(3) 255-267
Documenti SIBioC - SIBioC Documents
 
Utilizzo in Pronto Soccorso dei metodi ad alta sensibilità per le troponine cardiache per i pazienti con sospetto di infarto acuto del miocardio senza sopraslivellamente del tratto ST Documento Congiunto del Gruppo di Studio Inter-Societario sui Biomarcatori Cardiaci delle Società Italiane di Biochimica Clinica: European Ligand Assay Society, Sezione Italiana (ELAS), Società Italiana di Biochimica Clinica e Biologia Molecolare Clinica (SIBioC), Società Italiana di Patalogia Clinica e Medicina di Laboratorio
Use of the high-sensitivity methods for cardiac troponins measurement in patients admitted to the Emergency Department with a clinical suspicion of a non-ST segment elevation myocardial infarction Joint document of the Italian Societies of Clinical Biochemistry: European Ligand Assay Society, Sezione Italiana (ELAS), Società Italiana di Biochimica Clinica e Biologia Molecolare Clinica (SIBioC), Società Italiana di Patologia Clinica e Medicina di Laboratorio (SIPMeL).
<p>The use of serial measurement of cardiac troponin (cTn) is recommended by international guidelines for the diagnosis of myocardial infarction (MI) since 2000. However, the are some relevant differences among the recommendations proposed by the three different international guidelines published in 2020-2021 for the management of patients admitted to the Emergency Department (ED) with a clinical suspicion of a non-ST-segment elevation MI (NSTEMI). In particular, there is no agreement among these authoritative international guidelines about the cut-off or absolute change values to be used for diagnosis of MI. Another important controversial issue is whether there are, at present time, sufficient evidences on the diagnostic accuracy and cost effectiveness related to cut-off values suggested for the most rapid algorithms (0-1 or 0-2 hours) recommended for the rule-in/rule-out of NSTEMI. Finally, another important issue concerns the possible bias existing between the demographic and clinical characteritics of the patients enrolled in some multicenter trials compared to those routinely admitted to ED of the city Hospitals of some European countries, including Italy, for the diagnosis of NSTEMI. Considering the recommendations from these international guidelines, the Study Group of Cardiac Biomarkers, supported by the Italian Scientific Societies SIBioC&nbsp;(Societ&agrave; Italiana di Biochimica Clinica), ELAS (Italian Society of the European Ligand Assay Society) and SIPMeL (Societ&agrave; Italiana di Patologia Clinica e medicina di Laboraratorio), decided to revise the document previously published in 2013 about the management of patients admitted to ED with suspect NSTEMI, and so to prepare suggestions more specifically designed for the clinical institutions operating in the healthcare system in Italy.</p>
Biochimica Clinica ; 45(4) 412-426
Documenti SIBioC - SIBioC Documents
 
Biomarcatori cardiaci: dove stiamo andando?
Cardiac biomarkers: where are we going?
<p>The measurement of cardiac troponins (cTn) is recommended by all guidelines as the gold standard for the detection of differential myocardial injury and acute myocardial infarction (AMI). In this article, some key issues regarding both analytical characteristics of the high-sensitivity methods for cTn, which are still considered controversial or unresolved are discussed in details. These issues have been included in the activities of the Joint Working Group on &ldquo;Cardiac Biomarkers&rdquo; of the Italian Society of Clinical Biochemistry and the Italian branch of the European Ligand Assay Society. The major clinical concern regarding hs-cTn methods is the difficulty to differentiate the pathophysiological mechanism responsible for biomarker release from cardiomyocytes after reversible or irreversible injury, respectively. High-sensitivity cTnI and cTnT methods (hs-cTn) enable to monitor myocardial renewal and remodelling, and to promptly identify patients at highest risk of heart failure. In addition, several studies demonstrated that the cardiovascular risk progressively increases in the general population even for hs-cTn values well below the 99th percentile, i.e. the recognized cut-off for the detection of myocardial injury and diagnosis of AMI. An early and effective treatment of individuals at higher cardiovascular risk may revert the initial myocardial remodelling and slow down heart failure progression. Finally, recent studies support the working hypothesis that a new generation of hs-cTn methods should be set up based on monoclonal antibodies, specific for circulating peptide forms more characteristics for reversible rather than irreversible myocardial injury. Of course, screening programs of cardiovascular risk stratification and prevention strategies using hs-cTn methods require further investigation to define the optimal target populations, timing of measurement, and preventive interventions.</p>
Biochimica Clinica ; 45(1) 068-074
Documenti - Documents
 
Valutazione precoce del danno cardiaco da farmaci chemioterapici: importanza della misura delle troponine cardiache I e T con metodi ad alta-sensibilità analitica
High-sensitivity cardiac troponin I and T methods for the early detection of myocardial injury in patients on chemotherapy
<p>Important advances achieved in pharmacological cancer treatment have led progressively to a reduction in mortality from many forms of cancer, and increasing numbers of previously incurable patients can now hope to become cancer-free. Yet, to achieve these improved outcomes a high price has been paid in terms of untoward side effects associated with treatment, cardiotoxicity in particular. Several recent studies have reported that cardiac troponin assay using 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 recently suggested that changes in hs-cTn values enable the early diagnosis of cardiac injury from chemotherapy, thus potentially benefitting cancer patients with increased troponin values by initiating early cardioprotective therapy. However, large randomised clinical trials are needed in order to evaluate the cost/benefit ratio of standardised protocols for the early detection of cardiotoxicity using the hs-cTn assay in patients treated with chemotherapy.</p>
Biochimica Clinica ; 44(3) 279-286
Documenti SIBioC - SIBioC Documents
 
Calcolo e valutazione dei valori di riferimento della troponina cardiaca I (cTnI) misurata in un gruppo di volontari sani italiani con metodi immunometrici ad alta sensibilità: uno studio multicentrico
Establishment and evaluation of cardiac troponin I reference values measured in a group of Italian healthy volunteers using high-sensitivity methods: a multi-center study.
<p>Introduction: this study compares the cardiac troponin I (cTnI) values measured with three high-sensitivity (hs) different methods in apparently healthy volunteers enrolled in a multicenter study.<br />Methods: heparinized plasma samples were collected from 1511 volunteers in 8 Italian clinical institutions (mean age 51.5 years, SD 14.2, range 18-86, female to male ratio 0.94). All volunteers denied chronic or acute diseases and had normal values of routine laboratory tests and ECG. The reference laboratory of the study (Laboratorio Fondazione CNR Regione Toscana G. Monasterio, Pisa, Italy) assayed all plasma samples with three hs-methods: Architect hs-cTnI, Access hs-cTnIand ADVIA Centaur XPT hs-cTnI. After the exclusion of outlier values, calculation of 99th percentile (Upper Reference Limit, URL) values was performed using both robust nonparametric and bias corrected and accelerated bootstrap methods.<br />Results: large between-method differences were found. ADVIA Centaur measured higher cTnI values (up to 2-fold) than the two other methods. cTnI values were significantly higher in men than in women, and progressively increased with age over 55 years. Moreover, 99th percentile URL values also depended on the statistical approach used for calculation (robust non-parametric versusbootstrap). All 99th percentile URL values calculated with non-parametric robust method were on average slightly lower than those suggested by manufacturers (mean difference 4.2 ng/L, standard error 1.7, p=0.0273).<br />Conclusion: clinicians should be advised that plasma samples from the same patient should be measured for hs-cTnI in the same laboratory. Specific clinical studies are needed to establish the most appropriate statistical approach to calculate 99th percentile URL values for hs-cTnI methods.</p>
Biochimica Clinica ; 44(2) S032-S047
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 ; 44(2) S017-S031
Rassegne - Reviews
 
Le troponine I e T sono biomarcatori cardiaci interscambiabili?
Are troponin I and T interchangeable biomarkers?
<p>The most recent international guidelines recommend that high-sensitivity (hs) methods should be preferred for the measurement of cardiac troponin I (cTnI) and T (cTnT) for the detection of myocardial injury and the differential diagnosis of acute coronary syndromes. Furthermore, these guidelines state that there is no significant difference in accuracy among hs cTnI and cTnT methods for diagnosis of acute myocardial infarction. Myocardial injury is a prerequisite for the diagnosis of acute myocardial infarction, but it is also a distinct entity. The 2018 Fourth Universal Definition of Myocardial Infarction states that myocardial injury is detected when at least one value above the 99th percentile upper reference limit is measured in a patient by high-sensitivity methods for cTnI or cTnT. Occasionally, discrepancies between hs-cTnI and hs-cTnT test results can be found, when tested in the same blood sample. Several studies have reported discrepancies between hs-cTnI and hs-cTnT test results in some clinical conditions (especially chronic neuromuscular diseases) or even in apparently healthy subjects. This review, summarizes and discusses the biochemical, pathophysiological and analytical possible mechanisms causing discrepancies between hs-cTnI and hs-cTnT test results.</p>
Biochimica Clinica ; 44(2) S008-S016
Rassegne - Reviews
 
Patologie cardiovascolari e troponine cardiache: la storia di un legame indissolubile
Cardiovascular diseases and cardiac troponins: the history of a lasting connection
<p>The evolution of the biochemical diagnosis of cardiac diseases, represents a paradigm of the laboratory medicine evolution in the recent years.<br />Starting from the use of poor specific and sensitive biomarkers, the &ldquo;so-called&rdquo; cardiac enzymes (aspartate aminotransferase; lactate dehydrogenase; creatine kinase) recommended by World Health Organization for the acute myocardial infarction (AMI) diagnosis, a fundamental development in biochemical knowledge has been obtained, providing new biomarkers (CK-MB, myoglobin) for a more specific and early diagnosis according to the clinical and therapeutic needs. However, the revolutionary biochemical issue has been represented by the discovery of cardiac troponins and by the implementation of methods allowing their measurement in emergency setting in patients with acute chest pain. Cardiac troponins, are characterized by an absolute cardiac specificity and by a high sensitivity that allow to carry out a timely and safe diagnosis of AMI, being recognized as &ldquo;gold standard&rdquo; in all clinical and biochemical guidelines. In patients with acute chest pain and in ischemic clinical setting, a typical kinetic release of biomarker concentration may be suggestive of AMI even if ECG typical patterns are lacking. The actual improvement in analytical performance of troponins methods, particularly in the analytical sensitivity, allows to extend the measurement also in diagnosis of minor myocardial damage in patients suffering from different cardiac disease, to monitor the efficacy of therapy, the progression of the disease and to provide prognostic information and risk-stratification in addition to the clinical pathway.</p>
Biochimica Clinica ; 44(2) S067-S073
Opinioni - Opinions
 
Troponine cardiache: attualità analitiche e prospettive di applicazioni cliniche
Biochimica Clinica ; 44(2) S005-S007
Editoriale - Editorial
 
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 ; 44(2) S086-S096
Documenti SIBioC - SIBioC Documents
 
Medicina di Laboratorio e Medicina d’Urgenza: il connubio continua
Laboratory medicine and emergency medicine: a perpetual relationship.
<p>The essential goals that laboratorymedicine shall pursue to adequately fulfill clinical needs can be summarized in delivering high quality information,availability of clinically usable tests and turnaround time. The governance of urgent laboratory testing encompassesa harmonious integration of clinical needs and laboratory organization. Clinical laboratories shall hence be morefocused on the pre-preanalytical phase, be involved in proactive efforts for standardizing pre-analytical and analyticalprocedures, optimize the post-analytical and post-post-analytical phases, thus providing a complete information andallowing the achievement of favorable outcomes. Throughout this ample and multifaceted process, the strictcooperation between laboratory professionals and emergency physicians is pivotal. As rationale follow-up of thecollective article published concomitantly with the first joint Academy of Emergency Medicine and Care (AcEMC) -Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) meeting, this new collective paperaims to summarize the topics discussed during the second joint event &ldquo;Laboratory Medicine and EmergencyMedicine: a resumed link&rdquo;, specifically including the governance of urgent tests, acid-base disorders, venousthromboembolism, acute heart failure, trauma, acute intoxications, viral diseases and other emerging infections.</p>
Biochimica Clinica ; 43(3) 296-304
Documenti - DOCUMENTS
 
Specifiche di qualità, terminologia e definizione dei metodi di misura delle troponine cardiache Ie T
Quality specifications, terminology and definition of the methods for the measurement of cardiac troponins
<p>All guidelines recommend that cardiac troponin I (cTnI) and T (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 value for cardiac troponins should be measured with an imprecision &le;10 CV%. However, only after the year 2006, some cTn methods showed analytical performances in accordance with the quality specifications required by guidelines. The cTn methods with the best analytical performances (currently named &ldquo;high-sensitivity&rdquo; methods) should be preferred for the early diagnosis of ACS and also for risk stratification of cardiovascular disease both in general population and cardiac patients. The most recent international guidelines recommend that two basic criteria are needed to define the characteristics required for cTn immunoassays in order to be defined as &ldquo;high-sensitivity&rdquo; methods. The first criterion is that the total imprecision (CV) at the 99th percentile value should be &le;10%. The second criterion is that these methods should measure cTn concentrations at least in 50% (and ideally &gt;95%) of both healthy adult men and women with value above the assay&rsquo;s limit of detection. The aim of this SIBioC document is to discuss some critical aspects related to definition of &ldquo;high-sensitivity&rdquo; cTn methods, including: analytical performance, pathophysiological interpretations, and clinical relevance of &ldquo;high-sensitivity&rdquo; cTn assays with particular attention to routine practice of clinical laboratories in Italy, recommending the use of an accurate terminology to avoid the usage of potentially misleading terms.</p>
Biochimica Clinica ; 42(4) 335-342
Documenti SIBioC - SIBioC Documents
 
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
 
Armonizzazione in Medicina di Laboratorio
Harmonization in Laboratory Medicine
F. Ceriotti  |  M. Panteghini  |  A. Tosetto  |  V. Valentini  |  L. Politi  |  R. Rolla  |  T. Guastafierro  |  T. Köken  |  E. Capoluongo  |  C. Mazzaccara  |  V. D'Argenio  |  V. D'Argenio  |  G. Lippi  |  M. Plebani  |  D. Giavarina  |  M. Berardi  |   A survey on sample matrix and preanalytical management in clinical laboratories  |  D. Bozzato  |  G. Messeri  |  M. Zaninotto  |  M. Vidali  |  A. Padoan  |  G. Parigi  |  A. Clerico  |  L. Sciacovelli  |  M. Ciaccio  |  G.L. Salvagno  |  G. Barberio  |  G. Barberio  |  G.L. Salvagno  |  M. Pepe  |  M. Panteghini  |  F. Braga  |  G. Gessoni  |  M. Montagnana  |  N. Doğan  |  M. Barberis  |  M. Barberis  |  A. Marchetti  |  F. Borrillo  |  L. Bonfanti  |  P.M. Ness  |  G. Messeri  |  S. Nannini  |  J. Queraltò  |  M. Zaninotto  |  A. Mosca  |  BM. Henry  |  G. Santini  |  A. Coglianese  |  V. D'Argenio  |  E. Fiorio  |  L. Crinò  |  M. A. V. Willrich  |  A. Modenese  |  M. Berardi  |  G. Nordera  |  M. Girelli  |  R. Tomaiuolo  |  D. Giavarina  |  R. Dittadi  |  L. Pighi  |  V. Guaraldo  |  G. Bambagiotti  |  E. Franceschini  |  R. Danesi  |  M. Locatelli  |  F. Balboni  |  D. Cosseddu  |  M. Savoia  |  S. Bernardini  |  C. Domenichini  |  M. Lamonaca  |  M. Perrone  |  M. Perrone  |   per il Gruppo di Studio Intersocietario SIBioC-SIPMeL Diabete Mellito  |  P. Pradella  |  A. Padoan  |  M.T. Sandri  |  L. Belloni  |  A. D'Avolio  |  T. Trenti  |  A. Fortunato  |  T. Trenti  | 
Biochimica Clinica ; 39(6) 546-547
Editoriale - Editorial
 
Stato dell’arte dell’immunodosaggio dei peptidi natriuretici di tipo B
State of the art of B-type natriuretic peptide (BNP) immunoassays
<p>Recent studies have demonstrated that the&nbsp;precursor of BNP (proBNP) constitutes the major part of BNP-related peptides detectable in plasma of patients with&nbsp;heart failure by the commercially available immunoassays considered specific for the BNP hormone. Since proBNP&nbsp;significantly cross-reacts with commercial immunoassays for BNP, manufacturers should test and clearly declare the&nbsp;cross-reaction with proBNP in their BNP methods. Owing to the differences in cross-reaction with proBNP as well as&nbsp;in specificity, respectively, for the NH2- or COOH-terminal part of the peptide hormone chain, BNP immunoassays show&nbsp;significant between-method differences. Immunoassays for NT-proBNP, which all use standard materials and&nbsp;antibodies provided by the same company, show lower differences (generally minore del 20%). Clinicians should take into&nbsp;account these differences among methods when they compare results obtained from different laboratories, which use&nbsp;different BNP immunoassays. Accordingly, the use of a common decisional limit for all BNP immunoassay methods,&nbsp;as suggested by the most recent international guidelines, may be unreliable.</p>
Biochimica Clinica ; 39(5) 312-325
Rassegne - Reviews
 
Rilevanza clinica e interpretazione dei marcatori biochimici nello scompenso cardiaco
Clinical relevance and interpretation of biochemical markers in heart failure
<p>Heart failure (HF) is a global&nbsp;problem with an estimated prevalence of 38 million patients worldwide. Both prevalence and incidence of HF increase&nbsp;progressively with population ageing (prevalence &ge;10% in people &gt;75 years), especially in the high-income countries.&nbsp;HF is considered as the fatal event of all cardiovascular disorders. Despite some progress in diagnosis and treatment,&nbsp;its prognosis is worse than that of most cancers. The disease is heterogeneous in its clinical presentation and the&nbsp;diagnosis is not based on a single test, but on a combination of the history, physical examination and appropriate&nbsp;investigations, including some laboratory tests. As a consequence, the accuracy of diagnosis by clinical signs alone&nbsp;is often inadequate, especially in the early asymptomatic stage of HF. For these reasons, there is an increasing&nbsp;interest in the development of new biomarkers useful for the diagnosis, prognosis and follow-up of patients with HF.&nbsp;The aim of this paper is to provide an overview of biomarkers recommended by international guidelines for HF,&nbsp;discussing their clinical impact and the interpretation of results. Furthermore, a possible strategy for the development&nbsp;and evaluation of novel prognostic biomarkers for HF will be suggested.</p>
Biochimica Clinica ; 39(4) 241-255
Rassegne - Reviews
 
Forme molecolari della y-glutammiltransferasi: caratteristiche e biogenesi
y-Glutamyltransferase (GGT) fractions: characteristics and biogenesis.
<p>Four GGT fractions (b-, m-, s- and f- GGT) have been described in plasma. The aim of this study was to characterize their molecular nature in human plasma and bile. Plasma was obtained from healthy volunteers and primary bile was collected from patients undergoing liver transplant. For each GGT fraction we determined MW, density, sedimentation conditions in centrifugation assays, and the sensitivity to detergent [deoxycholic acid (DOC)] and protease (papain). A partial purification of b-GGT for immunogold analysis was obtained by ultracentrifugation. Plasma b-GGT showed a MW of 2000 kDa and a density between 1.063-1.210 g/mL. Treatment with 1% DOC converted b-GGT into s-GGT fraction, while b-GGT was not sensible to papain treatment. Plasma m-GGT and s-GGT showed a MW of 1000 and 200 kDa, and their densities were between 1.006-1.063 g/mL and 1.063-1.210 g/mL, respectively. Both fractions were unaffected by DOC treatment, while GGT activity was completely recovered in f-GGT peak after their incubation with papain. Plasma f-GGT showed a MW of 70 kDa and a density &gt;1.21 g/mL. In human hepatic bile we identified two peaks showing the same characteristics of plasma b- and f-GGT fractions. Collected data showed that b-GGT is constituted by membrane microvesicles both in bile and plasma, as confirmed by immunogold; m-GGT and s-GGT might be constituted by bile-acid micelles, while f-GGT represents the free-soluble form of the enzyme. The&#160; understanding of the nature and properties of plasma GGT fractions may allow a better clinical utilization of GGT as a clinical biomarker.&#65279;</p>
Biochimica Clinica ; 36(2) 112-120
Contributi Scientifici - Scientific Papers
 
Programma scientifico del Gruppo di Studio SIBioC-ELAS dei Biomarcatori Cardiaci (triennio 2021-2023)
Italian Study Group on cardiovascular risk factors: Scientific Program (years 2021-2023)
<p>The principal aim of this document is to provide a detailed documentation of the scientific activity carried out by the Italian Study Group on Cardiovascular biomarkers during these last three difficult years characterized by COVID-19 pandemic, that has put in strain the activity of all clinical laboratories (not only in Italy). Another important aim of this document is to discuss some important pathophysiological and clinical issues related to cardiac-specific biomarkers (i.e., cardiac natriuretic peptides and cardiac troponins), that still need not only further theoretical investigation, but also some multicenter clinical trials in order to evaluate and to improve their utilization in diagnosis, prognosis and managing of patients with cardiovascular disease</p>
Biochimica Clinica ; 17(1)
Documenti - Documents