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

International Advisory Board Khosrow Adeli Canada
Sergio Bernardini Italy
Marcello Ciaccio Italy
Eleftherios Diamandis Canada
Kjell Grankvist Sweden
Hans Jacobs The Netherlands
Eric Kilpatrick UK
Magdalena Krintus Poland
Giuseppe Lippi Italy
☩Howard Morris Australia
Mario Plebani Italy
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 M. Zaninotto

Il consolidamento dei Servizi di Medicina di Laboratorio
Biochimica Clinica ; 43(2) 123-124
Editoriale - Editorial
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
Glycated albumin is correlated to insulin resistance and β-cell secretory function in subjects at risk of developing diabetes
<p>Insulin resistance and &beta;-cell secretory function represent two main issues in the pathogenesis of type 2 diabetes mellitus (T2DM). Conflicting results have been obtained about the association between glycated albumin (GA) and body mass index (BMI), insulin resistance and &beta;-cell function in diabetic patients. Actually, the relationship (if any) between GA and the markers of glucose homeostasis and insulin resistance in subjects at risk of developing diabetes, has not been completely elucidated yet. Two hundred and one patients undergoing to oral glucose tolerance test (OGTT) were enrolled in the study. Routine laboratory tests, including fasting insulin, were performed at enrollment. GA was measured on plasma-EDTA by quantILab<sup>&reg;</sup> Glycated Albumin (Instrumentation Laboratory, A Werfen Company) on ILab Taurus analyzer. According to the plasma glucose concentration measured after 2 hours of glucose intake (2h- PG), 13 subjects (6.4%) were classified as impaired glucose tolerance (IGT). GA weakly correlated with fasting plasma glucose (FPG) (r=0.21; P=0.002), with HbA1c (r=0.16; P=0.024) but not with 2h-PG (P=0.7). GA, but not HbA1c, was negatively correlated to HOmeostasis Model Assessment for &beta; cell fuction (HOMA-&beta;) (r<sup>2</sup>=0.23; P&lt;0.001), to HOMA for insulin resistence (HOMA-IR) (r<sup>2</sup>=0.15; P&lt;0.0001) and to BMI (r<sup>2</sup>=0.05; P=0.001). In a stepwise multivariate regression analysis including HbA1c, HOMA-&beta;, plasma albumin, BMI, eGFR, age, FPG, and HOMA-IR as predictors of GA, only HbA1c (&beta;-coefficient: 0.04; P=0.038) and HOMA-&beta; (&beta;-coefficient: -0.01; P&lt;0.0001) were able to predict GA levels (r<sup>2</sup>=0.26; P&lt;0.001 for the model). Our results demonstrated that GA was associated to HOMA-&beta; and, to a lesser extent, to HOMA-IR and BMI. The increase of GA values can be explained by the reduction of &beta;-cell secretory function in subjects with no significant increase of FPG and 2h-PG.</p>
Biochimica Clinica ; 42(3) 234-239
Contributi Scientifici - Scientific papers
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
La diagnostica di laboratorio delle dislipidemie
The laboratory diagnosis of dyslipidemia
<p>Dyslipidemias represent a major contributor to cardiovascular risk in Western countries, including Italy, that can be modified. After examining familial dyslipidemias and describing the essential issues for clinical and laboratory diagnostics, the paper considers the laboratory testing in detail. The preanalytical sources of variability (biological, sample collection and handling) are reviewed and essential indications to reduce them are given. About the analytical variability, the paper examines the methods routinely used for measuring the basic lipid parameters (total, LDL and HDL cholesterol, triglycerides and apolipoproteins A-I and B) and describes the state of art of the standardization of these analytes. The last section of the document deals with the reporting of laboratory results. The main indications of the document are the following: a) report the desirable values established by the European guidelines besides the measured concentrations; b) make always clear that the reported values are decisional cut points and not reference limits; c) add a note stating that the reported desirable values refer to individuals at low risk; d) report as critical values lipid concentrations deserving rapid clinical attention, i.e., total cholesterol, &ge;8,00 mmol/L (310 mg/dL); LDL cholesterol, &ge;4,90 mmol/L (190 mg/dL); triglycerides, &ge;10,0 mmol/L (880 mg/dL).</p>
Biochimica Clinica ; 40(4) 338-346
Documenti SIBioC - SIBioC Documents
L’iniziativa dei laboratori della Regione Veneto “Passaggio al Litro”
"Switching to the Liter": the initiative of laboratories in Veneto Region
Biochimica Clinica ; 40(2) 166-167
Lettere all'Editore - Letters to the Editor
Sindrome POEMS: “Hevylite” e “Freelite” a confronto
POEMS syndrome: Heavy Light Chains vs Free Light Chains measurements
<p>POEMS syndrome is a rare paraneoplastic, multisystemic, plasma cell discrasia characterized by Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy and Skin changes. Most patients have high serum free light chains (sFLC) concentrations but a normal sFLC ratio. Hevylite (HLC) is a new method that allows separated quantification of the serum k and l bounded levels of the six isotype specific immunoglobulins. In this study HLC and sFLC were measured in serum samples during the follow up of two patients with POEMS syndrome. The HLC ratio of the involved monoclonal immunoglobulin could provide additional information to assess residual disease, allowing&nbsp; detection of relapse earlier than clinical symptoms in patients with POEMS syndrome.</p>
Biochimica Clinica ; 40(1) e1-e3
Casi clinici - Case report
Caso atipico di orticaria
A case of atypical urticaria
<p>Adult onset Still&rsquo;s disease (AOSD) is a rare clinical entity with unknown etiology and&nbsp;pathogenesis, characterized by high spiking fevers, arthritis, typical evanescent, nonpruritic, macular and salmon<br />coloured rash, and multiorgan involvement. AOSD remains a diagnostic challenge due to the overlapping features&nbsp;with numerous infective, neoplastic and rheumatological conditions. A case of AOSD with atypical cutaneous&nbsp;manifestations in a 50-year-old female is reported. The patient&rsquo;s symptoms included: remittent fever, widespread&nbsp;urticarial, maculopapular erythema and a sore throat. Hematological investigations showed leukocytosis with&nbsp;neutrophilia. There were markedly elevated levels of serum ferritin (20.920 &mu;g/L) and mild liver dysfunction. A&nbsp;glycosylated ferritin assay was performed because of a severe hyperferritinemia, showing a reduction of the&nbsp;glycosylated fraction (&lt;20%), a newly proposed diagnostic criteria for AOSD. We emphasize the diagnostic value of&nbsp;low glycosylated ferritin concentration for the differential diagnosis of this rare disease, particularly in case of atypical&nbsp;presentation.</p>
Biochimica Clinica ; 39(5) e10-e12
Casi clinici - Case report
Raccomandazioni per la diagnosi neonatale delle emoglobinopatie
Recommendations for the diagnosis of hemoglobinopathies at birth
<p>The laboratory plays an important role in the&nbsp;diagnosis of hemoglobin defects at any age. At the time of birth its role is particularly significant, considering that&nbsp;frequently the newborn has not clinical signs, even when he is carrying thalassemia or other structural defects of&nbsp;hemoglobin. The diagnostic precocity in the affected newborn will help to predict risk, determine appropriate prophylaxis&nbsp;and prevent complications. It may also be helpful for programming treatment and parent control, and planning a&nbsp;prevention for a future pregnancy. In Italy, there have been important demographic and social health changes over the&nbsp;past decade that have suggested the implementation of hemoglobinopathy screening at birth. In addition, the need to&nbsp;know the hemoglobin pattern of the cord blood for possible biobank storage should be regarded as another relevant&nbsp;target. Therefore, it seems timely to define pathways, scope and limits of a correct thalassemia diagnosis at birth through&nbsp;specific recommendations. The Italian Society of Thalassemias and Haemoglobinopathies (SITE) had already published&nbsp;recommendations for first level thalassemia diagnosis, which were primarily focused on preconceptional prevention. This&nbsp;new document provides essential guidance about laboratory methods, pre- and post analytical information flows and&nbsp;about the most appropriate approach to be followed.</p>
Biochimica Clinica ; 39(2) 116-134
Documenti SIBioC - SIBioC Documents
Valore prognostico della determinazione di MR-proadrenomedullina e copeptina nello scompenso cardiaco cronico
MR-proadrenomedullin and copeptin: prognostic role in chronic heart failure
M.M. Mion  |  M. Zaninotto  |  B. Boffa  |  F. Tona  |  G. Masiero  |  F. Calabrò  |  S. Iliceto  |  M. Plebani  | 
Biochimica Clinica ; 35(3) 193
Linee guida per la gestione dei programmi di Valutazione Esterna di Qualità
Guidelines for External Quality Assessment Scheme organization
Biochimica Clinica ; 35(2) 107
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
Ridurre l’inappropriatezza in medicina di laboratorio: come, quando e perchè
Improving appropriateness in laboratory medicine: how, when and why
<p><span style="color:rgb(33, 29, 30); font-size:9pt">The issue of the appropriateness in laboratory medicine has been discussed from several years in association to theparallel onset of two aspects: 1) the significant increase in tests demand and utilization, thanks to the developmentof laboratory automation and information laboratory systems (LIS), that allow to provide timely and reliable results toclinicians; 2) the opportunity, thanks to new pathophysiological knowledge and new technologies to introduce newand more sophisticated tests in clinical practice, providing a relevant support to the clinician in the management ofpatients, according to the improved vision of personalized medicine. As a consequence, the potentialinappropriateness in test utilization and the need to manage demand and to reduce the redundant testing havereceived increasing concern. Several papers, in the recent literature, demonstrated that the inappropriateness inlaboratory test utilization may represent a potential source of errors, and interesting strategies have been proposedand progressively adopted in order to limit this problematic outcome. An essential issue is to assure appropriatenessnot only in test request, but in all steps of the testing cycle. In particular, some of the more relevant issues has beenlinked to: rationalization of laboratory test ordering prescription, thanks to development of a computerized clinicaldecision support systems; implementation of the reflexing tests rule; definition of the minimum retesting intervalaccording to the clinical and pathophysiological criteria; timely revision of the available panel tests in order to deletethose considered obsolete from clinical and analytical point-of-view and, finally, improving the education in demandmanagement. The &ldquo;clinical laboratory stewardship&rdquo; seems to be the new and shared strategy, that guarantees notonly the appropriate utilization and interpretation of laboratory tests improving efficacy and providing efficiency but,more importantly, the future of the discipline and the role of laboratory professionals in the context of new and morecomplicated clinical and economical scenarios.</span></p>
Biochimica Clinica ; 17(1)
Documenti SIBioC - SIBioC Documents