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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 R. Dittadi

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
 
Extra-analytical Point of Care Testing errors in the pandemic era
<p>Introduction: during the current SARS-CoV-2 pandemic phase, the use of rapid diagnostic devices outside the laboratory has expanded enormously, creating great opportunities but also new risks. Methods: the present observational study evaluated the type and frequency of errors of the extra-analytical phases through an active search on all unclear or ambiguous cases. 252 241 rapid antigenic tests performed outside the laboratory in different health facilities over a 132-day period were considered. The requests, the patient demographics and the results were later entered manually onto the Laboratory Information System (LIS). Results: through a number of data checks and internal reports, 2 556 cases of errors in the pre-examination phase were recorded, with a relative frequency of 12,274 parts per million (ppm). The vast majority of errors were observed in this phase; these were due mainly to computer communication problems induced by human errors that made the loading of results or the issuing of the reports difficult. The remaining cases involving erroneous personal data or patient identification amounted to 16 (64 ppm), confirming the relative safety of this phase in decentralized analysis. The errors identified in the post-examination phase were 540, with a relative frequency of 2140 ppm. The assessment of the severity of the errors with Failure Mode and Effect Analysis (FMEA) allowed us to identify in particular, the attribution of the report to the wrong person (20 ppm) and the manual transcription of an incorrect result (20 ppm). Discussion: this study contributes to the comprehension of the critical issues connected to the Point of Care Testing and made it possible to establish corrective actions: improving staff training, choice of instruments with reading devices and establishing direct computer connection for the entering of the requests and results to the LIS.</p>
Biochimica Clinica ; 46(2) 160-165
Contributi Scientifici - Scientific Papers
 
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
 
Valutazione degli anticorpi anti SARS-COV-2 nell’ambito di un progetto di costituzione di una banca di plasma iperimmune
SARS-COV-2 antibodies in patients candidates as donors of immune plasma
<p>Background: in this study SARS-CoV-2 serology was investigated, using three different methods, in a cohort of convalescent patients from SARS-CoV-2 infection, recruited for the establishment of a hyperimmune plasma bank.<br />Methods: SARS-CoV-2 serology was investigated in 326 subjects using three commercial methods: MAGLUMI (MAG) 2019-nCoV IgM CLIA, MAGLUMI 2019-nCoV IgG CLIA and DiaSorin (SOR) LIAISON SARS-CoV-2 S1/S2 IgG. Moreover, 143 subjects were tested using a plaque reduction micro neutralization assay.<br />Results: MAG IgG test and SOR IgG test showed a good agreement (Cohen&#39;s K index = 0.65, CI 95% 0.55 &ndash; 0.78). Considering SOR IgG test versus micro neutralization test, the observed cut-off values were: 85 AU/mL for a neutralizing titer of 1/80; 108 AU/mL for 1/160 titer and 144 AU/mL for 1/320 titer. Considering MAG IgG test versus micro neutralization test, the observed cut-off values were: 4 AU/mL for a neutralizing titer of 1/80, 5 AU/mL for 1/160 titer and 7 AU/mL for 1/320 titer.<br />Conclusions: in our experience, the MAG and SOR tests showed good agreement in identifying subjects with IgG antibodies to SARS-CoV-2. Obtained results confirmed a good correlation between the antibody concentration detected by the SOR IgG and the neutralizing titer determined by the plaque reduction test.</p>
Biochimica Clinica ; 45(2) 146-152
Contributi Scientifici - Scientific Papers
 
Documento congiunto di SIBIOC, della Società Italiana dell’Osteoporosi, del Metabolismo Minerale e delle Malattie dello Scheletro (SIOMMMS), della Sezione Italiana della European Ligand Assay Society (ELAS), e della Associazione Medici Endocrinologi (AME)
Joint Document from: Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC), Italian Society of Osteoporosis, Mineral Metabolism, and Skeletal Diseases (SIOMMMS), Italina Section of Ligand Assay (ELAS), Association of Endocrinolo
<p>Vitamin D, and its metabolites, have key roles in the functioning of virtually all tissues. Indeed, besides the unquestioned role in bone mineral metabolism, evidences have pointed out roles in inflammation and autoimmunity, skeletal muscle and cardiac function, neuromuscular communication. Therefore, vitamin D deficiency associates with&nbsp;rickets in the child, osteomalacia and increased risk of fracture in the adulthood and possibly with the increased risk<br />of other pathological conditions. In order to regulate the prescription of vitamin D supplementation (cholecalciferol, cholecalciferol/calcium salts, calcifediol) to the adult population, and consequently to contain the costs sustained by the National Health System, the Italian Medicine Agency (AIFA) has recently drafted the &ldquo;Nota 96&rdquo; identifying the categories of patients, based on the laboratory measurement of serum levels of 25(OH)D, that can benefit from the reimbursement of vitamin D therapy. If the &ldquo;Nota 96&rdquo;, AIFA has the merit to define rules in a field only sligtly regulated, several considerations emerged from its analysis. From an analytical point of view, the &ldquo;Nota 96&rdquo; does not consider the issues of reliability and reproducibility of 25(OH)D measurement and standardization of the units of measurement and reporting. On the clinical side, the &ldquo;Nota 96&rdquo; does not consider the epidemic vitamin D insufficiency/deficiency that needs an adequate preventive approach and, furthermore, beyond its roles, the agency indicates the clinical conditions for whom vitamin D prescription is allowed. This document analyses the content of &ldquo;Nota 96&rdquo; highlighting the points that need further evaluations and by giving possible different solutions; the document provides also recommendations on laboratory reporting of vitamin D measurements.</p>
Biochimica Clinica ; 44(4) 400-406
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
 
Troponina cardiaca ad alta sensibilità: risultati preliminari di un confronto tra un nuovo strumento “point-of-care” e i più comuni analizzatori impiegati nei laboratori clinici
High sensitivity cardiac troponin: preliminary results of a new point-of-care analyzer compared with the analyzers routinely used in clinical laboratories
<p>Introduction: cardiac troponin concentration measured using a point-of-care testing (POCT) analyzer could accelerate the management of patients awaiting assessment for suspected acute coronary syndrome without persistent ST-segment elevation in the emergency department (ED).<br />Methods: we evaluated a new high sensitivity cardiac troponin I (hs-cTnI) assay applied to the POCT PATHFAST&trade; (Gepa, Italia). The study of imprecision was carried out using commercial control materials and lithium-heparin plasma pools. The percentages of detectable hs-cTnI values between the Limit of Detection (LoD) and the 99th percentile as declared by the manufacturer were studied in a population of reference donors. The clinical diagnostic performance was evaluated in a population of patients presenting to the ED with chest pain (lithium-heparin plasma samples were collected at admission and 3 hours later), in comparison to the most common methods that measure hs-cTnI in clinical laboratories: Architect PLUS i2000SR, Dimension Vista, Advia Centaur XPT, UniCel DXI 800. Using the gender-specific 99thpercentile as declared from each manufacturer, the percentages of agreement and disagreement for the classification of hs-cTnI results were calculated as well as the Cohen&rsquo;s Kappa values.<br />Results: imprecision: concentration range (CV% range)=14.6-12227.3 ng/L (2.8-9.8%); % of hs-cTnI &gt;LoD and &lt;99th percentile in males and females were 30.0% and 18.5% respectively. The percentage ranges of agreement versus disagreement observed in the clinical study were 76.8-96.3% versus3.7-23.2% respectively, and the corresponding Cohen&rsquo;s Kappa values ranged from 0.532 to 0.864. The prevalence of discordant results was obtained on admission sample (range=59.1-83.3%).<br />Discussion: the observed analytical imprecision was satisfactory while the percentages of subjects with hs-cTnI&gt;LoD and &lt;99thpercentile were lower than those declared by the manufacturer because a limited number of subjects has been evaluated. The clinical performance has shown an overall satisfactory agreement with all the analytical platforms used.</p>
Biochimica Clinica ; 44(2) S059-S066
Contributi Scientifici - Scientific Papers
 
La fase pre-analitica dei campioni provenienti dal Pronto Soccorso: impatto della introduzione di un impianto di posta pneumatica nel miglioramento del tempo di risposta
Improving pre-analytical laboratory turnaround time for the emergency department: outcomes of a pneumatic tube system introduction
<p>Background: the pre-analytical phase of the stat tests requested by the Emergency Department (ED) has been rarelystudied in relation to the containment of the laboratory turnaround time (TAT).<br />Methods: through a pre-analytical workflow analysis in a large ED with &quot;Lean&quot; methodology, some improvementshave been activated, including the installation of a pneumatic tube system (PTS).<br />Results: significant improvement of TATs (23 minutes at 90th percentile) and also of length of stay (LOS) of EDpatients (53 minutes at 90th percentile) has been documented. The plasma concentrations of a number of analytesmeasured in samples transported manually and by PTS were very similar (lactic dehydrogenase excluded),demonstrating that PTS does not alter the integrity of the samples.<br />Conclusions: compared to manual transportation, the use of this PTS significantly reduced transport time and alsoimproved some pre-analytical flow phases within the ED. The system is suitable for the measurement of most of theanalytes commonly requested for ED patients.</p>
Biochimica Clinica ; 43(2) 150-155
Contributi Scientifici - Scientific Papers
 
Protocollo operativo per la verifica della comparabilità dei risultati di laboratorio ottenuti su più procedure analitiche
Protocol to verify the comparability of quantitative laboratory results obtained with different measurementprocedures.
<p>With the growth and merging of clinical laboratories, very frequently analytical tests are performed onmultiple instruments within one or multiple locations. In these situations, there is the need of verifying thecomparability of patient results obtained with different analysers and/or different measurement procedures. Theimportance of this verification is further emphasised when considering that it is included into the ISO 15189specifications. This protocol provides step-by-step guidance on how to assess results comparability in differentscenarios. Up to four experimental designs are presented to meet laboratories&rsquo; needs, with details and examples onfrequency of testing, definition of acceptability criteria, samples selection, sample size calculation, statistical analysisand reporting.</p>
Biochimica Clinica ; 43(2) 228-243
Documenti SIBioC - SIBioC Documents
 
Protocollo per la comparazione di due metodi analitici di laboratorio
Protocol for the comparison of two laboratory methods
<p>Method comparison is one of the main concerns in&nbsp;Laboratory Medicine. With the introduction of new methods with potential advantages (e.g., cost reduction, improvement&nbsp;in efficiency, easier procedures and maintenance) the laboratory staff should investigate if the field method in use may&nbsp;be replaced by the new candidate method without compromising analytical quality nor resulting in a different medical&nbsp;decision or patient management. Several statistical approaches and graphical tools are available to investigate sources&nbsp;of analytical error and for decision-making. In this article, we present an operative protocol for the comparison of two&nbsp;quantitative analytical methods. All sequential steps, including experimental design, familiarization with the new method,&nbsp;quality assessment, sample selection, definition of acceptability criteria, sample measurement, data analysis and&nbsp;evaluation, final decision and reporting, are discussed and exemplified.</p>
Biochimica Clinica ; 40(2) 129-142
Documenti SIBioC - SIBioC Documents
 
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