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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 G. Banfi

Big Data e Intelligenza Artificiale in Medicina di Laboratorio
Artificial intelligence and big data in laboratory medicine
<p><span style="color:rgb(33, 29, 30); font-family:calibri,sans-serif; font-size:9pt">In the last few years, artificial intelligence (AI) is gaining attention in several medical disciplines, including laboratory medicine (LM). The raised interest on AI has been fueled not only by the huge amounts of information daily generated, but also by the special natural context offered by laboratories, where digitalization have already occupied an important part of the routine workflow of patients&rsquo; data. Motivated by these topics and under the auspices of SIBioC, a conference on AI and big data was organized in May 2022 in Bologna, Italy. This conference covered several topics of AI and big data, including but not limited to the current and future perspectives, comprising ethical challenges and the role of laboratory specialists, including young professionals, the productive integration of AI with information technologies and with other digital infrastructure, such as the LOINC and the block chain. Furthermore, some examples of real application of AI in LM were reported, including diagnosis and monitoring of familiar hypercholesterolemia, management of insulin treatments for diabetes, reference intervals identification and verification by indirect methods, COVID-19 diagnosis and the monitoring of outpatients monoclonal gammopathy treatment by digital healthcare</span></p>
Biochimica Clinica ; 47(1) 074-081
Documenti - Documents
 
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 del materiale biologico residuo nel laboratorio clinico
Use of residual biological material in the clinical laboratory.
G. Banfi  | 
<p>The clinical laboratory plays a central role in the evaluation of new diagnostic methods and procedures. It is common practice to use biological material from clinical practice for this purpose. The starting assumption is that the biological material is first of all used for the diagnostic and analytical procedures required by the medical prescription and that any further use must be subject to external authorization (Ethics Committee) and consent of the patient (where the Ethics Committee deems it necessary). Specific authorizations are required for the transfer of biological material to other researchers and/or industries. In any case, the use of the data is allowed provided that these are anonymous or aggregated. National and/or international laws and rules also govern BioBanks management; these are responsible for systematically collecting biological samples with a public service function and some of them have a research function. In all cases, it may be necessary to re-obtain or supplement the informed consent, i.e., when the study&#39;s objectives for which the samples are to be analyzed have not been previously detailed. This Opinion paper deals with this complex and vast topic, considering that the prerequisite for using residual biological material is that was previously and adequately authorized. Some of the numerous regulations governing the use of residual biological material and sensitive data will therefore be mentioned. The purpose of the paper is to bring the issue to the attention of laboratory medicine professionals to stimulate the participation of scientific and professional associations in developing regulations and to provide tools for their optimal interpretation.</p>
Biochimica Clinica ; 45(4) 408-411
Opinioni - Opinion
 
Valutazione della risposta anticorpale post-vaccino COVID-19: fiat lux
M. Plebani  |  G. Banfi  |  G. Lippi  | 
Biochimica Clinica ; 45(3) 228-229
Editoriale - Editorial
 
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
 
Applicazioni cliniche della presepsina come biomarcatore diagnostico d’infezione: rassegna e aggiornamenti
Clinical application of presepsin as diagnostic biomarker of infection: overview and updates
<p>The appropriate identification of bacterial infection is the basis for effective treatment and control of infective disease. Among this context, an emerging biomarker of infection is presepsin (PSP), re-cently described as early marker of different infections. PSP secretion has been shown to be associ-ated with monocyte phagocytosis and plasmatic levels of PSP increase in response to bacterial infec-tion and decrease after antibiotic treatment, therefore it can be considered a marker of activation of immune cell response towards an invading pathogen. Different methods have been developed to measure PSP and this review will briefly describe the different clinical fields of application of PSP, ranging from intensive care to neonatal infection, to orthopedic and pulmonary infection as well as fungal infections and cardiovascular infections.</p>
Biochimica Clinica ; 44(1) 021-027
Rassegne - Reviews
 
Siero o plasma? Un quesito non nuovo che attende risposte nuove
Serum or plasma? An old question awaiting for new answers.
<p>There is a continual debate on what type of sample a clinical laboratory should use. While serum is still considered the gold standard and remains the required sample matrix for some assays, laboratories must consider turn-around time, which is an important metric for laboratory performance and, more importantly, plays a critical role in patient care. In addition, a body of evidence emphasize the choice of plasma samples in order to prevent modifications of some measurands due to the coagulation process and related interferences. Advantages and disadvantages of serum and plasma are discussed on the basis of current literature and evidence. In addition, data are provided on the current utilization of the matrix (serum or plasma) in Italy and in other Countries. Finally, a rational for a possible shift from serum to plasma is provided.</p>
Biochimica Clinica ; 43(2) 178-186
Documenti - Documents
 
Raccomandazioni per l’identificazione e la gestione dei risultati critici nei laboratori clinici
Recommendations for the detection and management of critical results in clinical laboratories
<p>Critical results, (also known as panic or alarm results) identify a laboratory test result associated with a serious risk for the patient&rsquo;s health, requiring immediate communication to the physician to establish appropriate therapeutic interventions. The adoption of an efficient procedure for the communication of critical values/results is crucial for clinical, ethical, organizational reasons, because it is a requirement for laboratory accreditiation and because of potential legal consequences related to the lack of notification of harmful laboratory results. In 2008, the Italian Society of Clinical Biochemistry and Laboratory Medicine (SIBioC) published its first consensus-based recommendation for the detection and management of critical values in clinical laboratories, with the aim to improve the implementation of standardized and universally accepted procedures, promoting an essential policy toward rational and efficient solutions to this issue. These new recommendations represent a complete review of the first document. Using the same consensus conference method between experts of scientific societies, the main aspects of clinical risk, patient safety and legal liability of health care workers were re-considered. The SIBioC and the Italian Society of Laboratory Medicine (SIPMeL), Intersociety Study Group on Standardization of extra-analytical variability of laboratory results, together with the Italian Society of Ergonomics and Human Factors (SIE) collaboration, issued the present join document.</p>
Biochimica Clinica ; 42(2) 167-179
Documenti SIBioC - SIBioC Documents
 
Le revisioni della letteratura biomedica
The reviews of the biomedical literature
<p>The reviews of the biomedical literature aim to summarize and disseminate the knowledge about a specific topic intended as a disease treatment or a diagnostic biomarker. They include narrative and systematic reviews (SR). Narrative reviews simply describe the features about a specific topic. On the contrary, SR are performed to answer to a specific question by using a standardized methodology to obtain results that may be reproduced by other authors. SR may include studies of diagnostic or therapeutic efficacy and prognostic value according to the scope. SR of treatment efficacy are generally focused on the efficacy of a new treatment in comparison with the one considered as reference, commonly used in the clinical therapeutic protocols. SR focused on diagnostic test accuracy generally retrieve data on diagnostic sensitivity and specificity from original studies in order to estimate pooled likelihood ratios or predictive values. Finally, SR of prognostic studies explore the ability of a specific marker to predict the outcome of interest. A SR implies to plan a systematic literature search strategy by Medline and other biomedical databases, defining inclusion criteria for study selection. Statistical analyses allow to pool data in a meta-analysis to provide an estimates of the effect power. This paper summarize the main features of different type of SR to help readers in the comprension of a SR and meta-analysis. Their utility in clinical practice and biomedical research is also illustrated.</p>
Biochimica Clinica ; 41(2) 175-182
Documenti - Documents
 
Verifica locale dei sistemi di prelievo nei laboratori clinici: adattamento delle linee guida EFLM
Blood collection systems in clinical laboratories: local adaptation of the EFLM guidelines
<p>The importance of the process of purchasing or changing blood collection devices is often overlooked. This is likely attributable to many factors such as the limited knowledge that policymakers, healthcare administrators and also laboratory managers have on the significance of preanalytical quality, but also to the lack of validated criteria for analyzing the quality of blood collection devices. Since a gap remains to be filled between companies&rsquo; and laboratory&rsquo;s validation, the EFLM Working Group on Preanalytical Phase (WG-PRE) has published a comprehensive document, which contains essential prerequisites and technical issues (e.g., physical imperfections, defects of functioning, safety deficiencies) to support local clinical laboratories for the development of tenders for blood tubes and for the validation of new materials ahead of local routine use. This consensus document is a national adaptation of these guidelines.</p>
Biochimica Clinica ; 40(4) 347-352
Documenti SIBioC - SIBioC Documents
 
Emoglobina glicata come indicatore di efficacia dell’attività fisica nel controllo del diabete
Glycated hemoglobin as an effectiveness indicator of physical activity for diabetes control
V. Pecoraro  |  G. Banfi  | 
<p>Type 2 diabetes&nbsp;is a complex disease. One of the strategies put in place to reduce body weight and controlling blood sugar&nbsp;concentrations is the physical exercise. Some studies have shown that physical activity improves glycated&nbsp;hemoglobin (HbA1c) concentrations, sensitivity to insulin and lipid profile. The objective of our work was to evaluate&nbsp;available studies that consider HbA1c as an indicator of effectiveness of physical exercise. We included 44 studies&nbsp;(37 randomized and 7 not randomized controlled trials) for a total of 3738 patients. The majority of studies reported&nbsp;a significant improvement of HbA1c concentrations confirming its role as effectiveness indicator. Physical exercise&nbsp;reduced the risk of developing diabetes mellitus in healthy subjects, reduced the cardiovascular risk in type 2 diabetic&nbsp;patients and increased HbA1c concentrations in athletes performing high intensity exercises.</p>
Biochimica Clinica ; 38(6) 607-614
Rassegne - Reviews
 
Proposta di una “checklist” per il prelievo di sangue venoso
Proposal of a checklist for venous blood collection
<p>The collection of venous blood is central in clinical laboratory&nbsp;activity. Although there is widespread perception that this practice is simple and free of complications and side effects,&nbsp;it is undeniable that the vast majority of laboratory errors arises from ignorance, incompetence or negligence during&nbsp;venipuncture. It has hence become advisable to prepare a document in simplified form of checklist, consisting of a&nbsp;concise but comprehensive list of activities to be completed or verified in order to prevent errors during venous blood&nbsp;collection. In the intention of authors, this synthetic checklist is a modular tool, adaptable to different local contexts,&nbsp;it can be easily and gradually implemented, it is supported by scientific evidence and consensus of experts and&nbsp;created with the support of different healthcare professionals and it is adherent to the best practices and requires&nbsp;minimal resources for implementation. It is reasonable to assume that this checklist may be able to withstand system&nbsp;and individual changes, strengthening the standards for safety of both operators and patients, limiting potential failure&nbsp;patterns. We hope that the checklist may be implemented in all healthcare facilities where routine venous blood&nbsp;collection is performed, after adaptation to suit characteristics of local organization.</p>
Biochimica Clinica ; 37(4) 312-317
Documenti SIBioC - SIBioC Documents
 
Raccomandazioni di consenso SIBioC-SIMeL per la rilevazione e gestione dei campioni emolisati e utilizzo dell'indice di emolisi
SIBioC-SIMeL consensus recommendations for the identification and management of hemolysed specimens and the implementation of hemolysis index
<p><strong>SIBioC-SIMeL consensus recommendations for the identification and management of hemolysed specimens</strong><br /><strong>and the implementation of hemolysis index.</strong> The presence of hemolysis in a biological blood sample is mainly<br />caused by hemolytic anemia or hemolysis in vitro. The latter is caused by inappropriate collection and processing of biological samples, which may affect the reliability of test results. Hemolysis is assessed by free hemoglobin quantification, whose limit is 0.02 g/L in plasma and 0.05 g/L in serum, and visually observed when the concentration of free hemoglobin exceeds 0.30 g/L. Since hemolysis is the most frequent cause of unsuitable biological samples in clinical laboratories, with a prevalence approaching 3% of all received samples, these recommendations have been drafted specifically to assist laboratory professionals in detection and management of hemolysed specimens. In summary, the recommended approach is based on: (i) systematic detection and quantification of hemolysis, by visual inspection and subsequent quantification of the hemolysis index on all samples with visually detectable hemolysis; (ii) immediate notification to the referring department of the presence of hemolysis in the sample, as locally determined; (iii) suppression of all results affected by the presence and/or degree of hemolysis; and (iv) timely request of a second sample, on which the previously deleted tests can be performed.</p>
Biochimica Clinica ; 35(6) 481-490
DOCUMENTI SIBioC - DOCUMENTI SIBioC