Maria Stella Graziani

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Martina Zaninotto

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Ferruccio Ceriotti
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
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Magdalena Krintus Poland
Giuseppe Lippi Italy
☩Howard Morris Australia
Mario Plebani Italy
Sverre Sandberg Norway
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☩Jill Tate Australia
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Paul Yip Canada

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BC: Articoli scritti da A. Clerico

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(5) 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
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
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 ; 17(1)
Documenti - DOCUMENTS
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 thebiochemical 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 (aspartateaminotransferase; lactate dehydrogenase; creatine kinase) recommended by World Health Organization for the acutemyocardial 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 andtherapeutic needs. However, the revolutionary biochemical issue has been represented by the discovery of cardiactroponins and by the implementation of methods allowing their measurement in emergency setting in patients withacute chest pain. Cardiac troponins, are characterized by an absolute cardiac specificity and by a high sensitivity thatallow to carry out a timely and safe diagnosis of AMI, being recognized as &ldquo;gold standard&rdquo; in all clinical andbiochemical guidelines. In patients with acute chest pain and in ischemic clinical setting, a typical kinetic release ofbiomarker concentration may be suggestive of AMI even if ECG typical patterns are lacking. The actual improvementin analytical performance of troponins methods, particularly in the analytical sensitivity, allows to extend themeasurement also in diagnosis of minor myocardial damage in patients suffering from different cardiac disease, tomonitor 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 ; 17(1)
Opinioni - Opinions