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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 L. Belloni

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)

A. Clerico \| M. Zaninotto \| A. Aimo \| DM. Cardinale \| R. Dittadi \| M.T. Sandri \| M. A. Perrone \| L. Belloni \| A. Fortunato \| T. Trenti \| M. Plebani \|
<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 >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

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).
A. Clerico \| M. Zaninotto \| R. Dittadi \| D. Cosseddu \| M. Perrone \| A. Padoan \| S. Masotti \| L. Belloni \| M. Migliardi \| A. Fortunato \| M. Plebani \| T. Trenti \| L. Malloggi \| P. Cappelletti \| G.A. Galli \| L. Sciacovelli \|
<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 (Società Italiana di Biochimica Clinica), ELAS (Italian Society of the European Ligand Assay Society) and SIPMeL (Società 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

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.
A. Clerico \| M. Zaninotto \| S. Masotti \| V. Musetti \| A. Ripoli \| A. Padoan \| R. Aloe \| S. Rizzardi \| R. Dittadi \| C. Carrozza \| L. Belloni \| M. Perrone \| T. Fasano \| M. Correale \| C. Prontera \| S. Storti \| C. Guiotto \| M. Migliardi \| M. Migliardi \| S. Bernardini \| M. Plebani \|
<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

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