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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

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
Andrea di Bello
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 M. Vidali

I Big Data e la Medicina di Laboratorio
M. Vidali  | 
Biochimica Clinica ; 45(1) 013-014
Editoriale - Editorial
 
La scienza riproducibile
The reproducible science
M. Vidali  | 
<p>Many studies in different areas of scientific research suggest that we are currently facing a deep reproducibility crisis. To illustrate the significance of the problem, results of some pivotal reproducibility projects of both social, economic and biomedical sciences are reported. Terminology proposed by different authors is presented and compared. The paper, according to a new lexicon for research reproducibility recently adopted, offers hints for discussion on possible causes and solutions for reproducibility of methods, results and inferential reproducibility as well. Moreover, open tools for reproducibility are briefly described. Reproducibility requires a new way to structure and organize a project, deeper understanding of the scientific process, mature statistical knowledge and the implementation of good existing policies and practices. These resource consuming activities are worth the effort, since they may contribute to establish a solid basis to build upon.</p>
Biochimica Clinica ; 44(4) 386-396
Opinioni - Opinions
 
Considerazioni relative alla tecnica statistica del bootstrap
A note to bootstrap methods
M. Vidali  | 
<p>The bootstrap is a computer-intensive method, part of the broad umbrella of resampling methods. It represents a different approach to statistical inference when population distribution is not known, when sampling distribution of the statistic of interest is intractable or assumptions are not met. Limiting the mathematical details, the paper focuses on the key idea of bootstrapping to resample with replacement from the observed sample and on how to implement the process. Bootstrap confidence intervals are briefly discussed.</p>
Biochimica Clinica ; 44(2) S079-S085
Opinioni - Opinions
 
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  |  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  |  E. Fiorio  |  L. Crinò  |  M. A. V. Willrich  |  A. Modenese  |  M. Berardi  |  G. Nordera  |  M. Girelli  |  R. Tomaiuolo  |  R. Danesi  |  M. Locatelli  |  M. Savoia  |  S. Bernardini  |  C. Domenichini  |  M. Lamonaca  |  P. Pradella  |  A. D'Avolio  | 
Biochimica Clinica ; 39(6) 546-547
Editoriale - Editorial
 
Stato dell’arte delle analisi farmacotossicologiche nei laboratori di tossicologia italiani
State of the art of pharmacotoxicological analyses in Italian toxicology laboratories
<p>Analyses for drug and&nbsp;substance abuse represent a considerable part of the daily workload of pharmacotoxicology laboratories (PL).&nbsp;Lacking specific rules, PL have developed their own analytical drug testing procedures and, in turn, personalized&nbsp;reports and interpretation. In 2013, the SIBioC Toxicology Study Group did a national survey to assess the situation&nbsp;of the Italian PL involved in drug testing. Here data from this survey are reported. The survey included two&nbsp;questionnaires aimed to clarify laboratory procedures used for workplace drug and drug and alcohol on the road,&nbsp;respectively. The variability of qualitative variables was evaluated by the Gini index of heterogeneity. Although a low&nbsp;response rate to the survey (&lt;30 respondents), data clearly showed a high heterogeneity of laboratory procedures,&nbsp;including preanalytical (custody chain, methods of sample collection, sample volumes, sample adulteration check),&nbsp;analytical (instrumentations, methods, cut-offs) and post-analytical aspects (qualitative or quantitative reporting), in&nbsp;some cases even different from procedures required by Italian law, when available. To avoid subjective interpretation,&nbsp;which could lead to different treatments of citizens, an harmonization of analytical procedures used by the Italian PL&nbsp;is mandatory.</p>
Biochimica Clinica ; 39(2) 100-107
Contributi scientifici - Scientific Papers
 
Rispondono gli Autori dell'articolo in questione
In reply
M. Vidali  |  G. Bellomo  | 
Biochimica Clinica ; 35(2) 158
LETTERE ALL'EDITORE - Letters to the Editor
 
Antibody identification in COVID-19 pandemic: a comparison between immunochemiluminescence and immunochromatography methods
<p>Introduction: in the fight against the COVID-19 pandemic, the determination of the serum antibodies against SARS-CoV-2 is highly relevant, although the reliability of the results delivered is sometimes questionable. The aim of this paper is to evaluate the performances of a rapid immunochromatography test for IgG and IgM antibodies, comparing them with an immunochemiluminescence method.<br />Methods: we analyzed 357 sera for the presence of IgG anti-SARS-CoV-2 spike proteins S1/S2 with an automated immunochemiluminescent test (DiaSorin&reg;) and the presence of IgG and IgM anti-SARS-CoV-2 nucleocapside protein with an immunochromatography method (LEPU&reg;) based on lateral flow technology.<br />Results: with Diasorin&reg; method, 248 subjects resulted to be negative and 109 positives, whereas LEPU&reg; test was positive (IgM+ and/or IgG+) in 98 subjects. The overall concordance between LEPU&reg; and DiaSorin&reg;, was 94.1% (95% CI 91.0-96.2). Cohen&rsquo;s kappa was 0.86 (95% CI 0.80-0.92), indicating good agreement. 21 out of 357 (5.9%) samples had a discordant result and were re-analyzed with a third method (Roche Diagnostics Electrochemiluminescence&reg;): 4 out of 5 DiaSorin&reg; negative/LEPU&reg; positive samples were confirmed as negative by Roche&reg;; conversely, among the 16 DiaSorin&reg; positive/LEPU&reg; negative samples, 5 were confirmed as positive by Roche&reg;, 6 as negative and 5 were not retested due to insufficient sample volume.<br />Conclusions: despite the methods were designed to detect different antibodies an overall high agreement between techniques was found. Discrepant results were found and were likely due to different antigen targets recognized by methods. The observation that only 6 out of 11 DiaSorin&reg; positive samples were not confirmed by ROCHE&reg;, supports the antigen-dependent hypothesis.</p>
Biochimica Clinica ; 17(1)
Contributi Scientifici - Scientific Papers