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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

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


ISSN print: 0393 – 0564
ISSN digital: 0392- 7091

BC: Articoli scritti da M. Vidali

Saliva: Challenges, possibilities, and limits of the diagnostic use Part 2 – Pre-analytical and analytical aspects
<p><span style="font-size:12px">Part I of this review was dedicated to the biological complexity of saliva and its relationship with the pathophysiology of many organs. In Part II, issues related to the pre-analytical and analytical phases are illustrated, focusing first the attention on the main sources of variability, starting from the few data available on biological variation to the different approaches for sample collection under basal or stimulated conditions. Up to now, published data, obtained on small groups of healthy or diseased individuals, seem to be indicative of wide pre-analytical errors and/or individual variability. The established clinical use of salivary tests is then reviewed and a series of possible new applications are presented. Methodologies employed in saliva are presented, ranging from commonly applied techniques, such as colorimetric enzymatic methods and ELISA, to more sophisticated technologies (gas chromatography&ndash;mass spectrometry, liquid chromatography-mass spectrometry and 1H NMR spectroscopy) to investigate proteomics and metabolomics. The aim of this review is to present the pre-analytical issues related to its collection and storage and to illustrate the knowledge gaps and the numerous opportunities that the analysis of this interesting biological fluid may offer.</span></p>
Biochimica Clinica ; 47(1) 012-028
Rassegne - Reviews
Saliva: challenges, possibilities, and limits of the diagnostic use Part 1 - Anatomical and basic pathophysiological aspects
Saliva: challenges, possibilities, and limits of the diagnostic use Part 1 - Anatomical and basic pathophysiological aspects
<p><span style="color:rgb(34, 30, 31); font-size:9pt">This review presents a detailed description of the saliva physiology (sources, composition, regulation of secretion) illustrating the complexity of this body fluid and its relationship with the pathophysiology of many organs. The knowledge of these aspects are of paramount importance to deeply understand main sources of variability, in keeping under control the pre-analytical phase and also to try to explain some contradictory results found in literature.&nbsp;</span><span style="color:rgb(34, 30, 31); font-size:9pt">Saliva is a biofluid with very interesting advantages: it is easy to self-collect, transport, and store. It is expected that saliva will have a key future role in the diagnosis of many diseases (metabolic disorders, cancer, oral and dental diseases, etc.) and useful for point-of-care testing.&nbsp;</span><span style="color:rgb(34, 30, 31); font-size:9pt">Part I of this review is a basic introduction to the saliva biological complexity; part II will follow, dealing with issues related to the pre-analytical and analytical phase.</span></p>
Biochimica Clinica ; 46(4) 292-300
Rassegne - Reviews
Sviluppo e validazione di un metodo analitico per la misurazione in neonati dell'ormone della crescita in campioni eluiti da carte filtro
Development and validation of a method for the measurement of growth hormone in newborns on dried blood spots.
<p>Introduction: severe deficiency of Growth Hormone (GHD) of the newborn is a rare but potentially life-threatening disease. GH can be measured during the first week of life when levels are physiologically higher. Aim of the study was to validate a method to measure GH in newborns from dried blood spots (DBS) for reference interval estimation. Methods: whole EDTA-blood and serum were&nbsp; collected from patients attending the Endocrinology Unit. 50 &micro;L of EDTA-blood was spotted onto Guthrie cards (LTA Srl) which were air dried at room temperature (RT) for 4 hours and processed or stored at -20&deg;C up to 8 months. Three disks (5.5 mm) were punched out into a 2 mL polypropylene tube and 250 &micro;L of PBS1x were added. Samples were incubated at RT for 16 hours and then centrifuged at 12 500 rpm for 1 min. GH in supernatants or undiluted sera was determined by Immulite 2000 (Siemens Healthineers) and a calibration curve was built. Results: linearity was verified (R2 &gt;0.99) up to 50 &micro;g/L. At 1 &micro;g/L, considered the Limit of Quantification (LOQ), CV% resulted to be 11%. Repeatability at 8 concentrations (from 1.5 to 50 &micro;g/L) ranged from 2.4% to 11.1%. At 7 &micro;g/L, the cut-off previously reported by literature for GHD, CV% was 3.7%. Within-laboratory imprecision, evaluated in a period of 8 months at two different concentrations (3.4 &micro;g/L and 10.1 &micro;g/L) was 13% and 5.9%, respectively. Conclusions. The new method displayed good analytical performances, suggesting it can be used to measure GH in newborns using DBS for reference interval estimation.</p>
Biochimica Clinica ; 46(4) 325
Contributi Scientifici - Scientific Papers
Preziose informazioni dall’esame del liquido pericardico
Valuable information from the examination of the pericardial fluid
<p><span style="font-family:calibri,sans-serif; font-size:9.0pt">A 63-year-old man, without previously known cancer disease, arrived at the Emergency room because of severe dyspnea. Electrocardiogram revealed right branch block and low ventricular repolarization voltages. Chest X ray and echocardiogram, instead, showed right pleural effusion and cardiac massive effusion. The patient underwent pericardiocentesis. The morphological study of pericardial fluid revealed the presence of numerous nonhematopoietic cells and the patient was admitted to the hosptital Thoracentesis was performed during hospitalization. The analysis of pleural fluid showed similar results to those obtained in pericardial fluid. A subsequent paracentesis was performed. Accordingly, this fluid showed similar atypical cells. Adenopathy in the supraclavicular area was found at the TC scan. Lymphnode biopsy confirmed a poorly differentiated proliferation, consistent with squamous cell carcinoma. In conclusion, morphological analysis of the pericardial fluid is a simple examination that, in a short time, may alert about the presence of unexpected atypical cells.</span></p>
Biochimica Clinica ; 46(3) e18-e21
Casi Clinici - Case Report
Evaluation of a panel of polymorphisms in vitamin D-related genes, vitamin D status and Multiple Sclerosis
Evaluation of a panel of polymorphisms in vitamin D-related genes, vitamin D status and Multiple Sclerosis
<p><span style="color:#333333; font-family:arial,sans-serif; font-size:10.0pt">Introduction: the role of hypovitaminosis D as risk factor for Multiple Sclerosis (MS) is well known. Vitamin D status</span> is the result of the interaction between environmental and genetic factors. Several single nucleotide polymorphisms (SNPs) in genes codifying for molecules involved in vitamin D pathway have been associated with an increased risk of MS. However, few studies evaluated the association of these SNPs with MS severity. The aim of this study was to investigate the association among a panel of vitamin D-related SNPs, vitamin D status, and MS severity. Methods: one hundred MS patients were enrolled in the study. Serum 25(OH)D3 levels and genotyping of SNPs in vitamin D-related genes were evaluated in all patients by high-performance liquid chromatography or real-time polymerase chain reaction. MS severity was assessed by Multiple Sclerosis Severity Score (MSSS). Results: three SNPs of the NADSYN1 gene, namely rs3829251, rs7944926 and rs12785878, and the rs2248137 SNP of the CYP24A1 gene were significantly associated with 25(OH)D3 levels. However, neither serum 25(OH)D3 levels nor the SNPs of the NADSYN1 or of the CYP24A1 genes were associated with disease severity. Discussion: in this study, we assessed the hypothesis that the presence of SNPs in vitamin D-related genes could influence MS severity. However, the statistical analysis indicates that there is no correlation between the severity of the disease and the polymorphisms considered.</p>
Biochimica Clinica ; 46(2) 122-125
Contributi Scientifici - Scientific Papers
Tecniche di apprendimento automatico basato sui risultati di esami di medicina di laboratorio nella diagnosi e prognosi per i pazienti COVID-19: una revisione sistematica
Machine Learning based on laboratory medicine test results in diagnosis and prognosis for COVID-19 patients: a systematic review
<p>The rapid detection of SARS-CoV-2 infections is essential for both diagnostic and prognostic reasons: however, the current gold standard for COVID-19 diagnosis, that is the rRT-PCR test, is affected by long turnaround time, potential shortage of reagents, high false-negative rates and high costs. Thus, Machine Learning (ML) based methods have recently attracted increasing interest, especially when applied to digital imaging (x-rays and CT scans).<br />In this article, we review the literature on ML-based diagnostic and prognostic methods grounding on hematochemical parameters. In doing so, we address the gap in the existing literature, which has so far neglected the application of ML to laboratory medicine. We surveyed 20 research articles, extracted from the Scopus and PubMed indexes. These studies were characterized by a large heterogeneity, in terms of considered laboratory and clinical parameters, sample size, reference population, employed ML methods and validation procedures. Most studies were found to be affected by reporting and replicability issues: among the surveyed studies, only three reported complete information regarding the analytic methods (units of measure, analyzing equipment), while nine studies reported no information at all. Furthermore, only six studies reported results on independent external validation. In light of these results, we discuss the importance of a tighter collaboration between data scientists and medicine laboratory professionals, so as to correctly characterize the relevant population, select the most appropriate statistical and analytical methods, ensure reproducibility, enable the correct interpretation of the results, and gain actual usefulness by applying ML methods in clinical practice.</p>
Biochimica Clinica ; 45(4) 348-364
Rassegne - Reviews
Utilizzo della differenza critica per una corretta interpretazione dei valori di creatinina sierica
A. Carobene  |  M. Vidali  | 
Biochimica Clinica ; 45(3) s104-s106
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 ; 45(2) 153-157
Contributi Scientifici - Scientific Papers
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  |  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
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