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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

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Chiara Riva
Biomedia srl
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Tel. 0245498282


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

BC: Articoli scritti da V. Pecoraro

Applicazione dell’analisi dei Big Data nella valutazione dell’utilità clinica della determinazione degli anticorpi anti SARS-CoV-2 di tipo IgM: l’esperienza di Modena
Big Data analysis to evaluate the clinical utility of IgM anti SARS-CoV-2 determination: the Modena experience
<p>Introduction: since the scarce diagnostic accuracy of specific circulating antibodies for SARS-CoV-2, we aimed to assess the clinical utility of IgM detection in SARS-CoV-2 using the Big Data analysis. Methods: this is a retrospective study; all the blood samples collected between March and September 2020 were processed using a lateral flow immunoassay (LFIA) kit for IgG and IgM antybody testing. Positives results were tested again using a chemiluminescent method. Subjects confirmed with a positive result were contacted for a molecular test.<br />Results: more than 69 000 serological tests (from 42 911 subjects) were performed. 94.5% (40 559/42 911) of subjects had negative results for both IgG and IgM. 1.5% (n = 640) subjects had both IgG and IgM positive results, and viral RNA research confirmed positivity in 16% (85/533). Among subjects with IgG negative and IgM positive results (n=271), a positivity was confirmed in 1% (4/270). Conversely, in subjects with IgG positive and IgM negative results, a positivity was confirmed in 8% (97/1 215). Therefore, the analysis suggests that up to 98% of serological test results of IgM positivity and IgG negativity are false positive.<br />Discussion: the study, based on Big Data analysis application, proved the scarce clinical utility of IgM detection in COVID-19 management, and underlines the responsibility of laboratory professionals in highlighting the limitations of the serological tests also due to uncertainty in their interpretation.</p><p>&nbsp;</p>
Biochimica Clinica ; 46(2) 154-159
Contributi Scientifici - Scientific Papers
Disegno e sviluppo di una applicazione per dispositivi mobili per migliorare l’appropriatezza prescrittiva degli esami di laboratorio del medico di medicina generale: focus sull’ipertensione arteriosa
An application for mobile devices to improve the appropriateness of laboratory test request by general practitioners: focus on blood hypertension
<p>The prevalence of consultations of general practitioners (GPs) is huge, and for an unknown number of patients a consistent amount of diagnostic laboratory tests is requested. One of the tasks of GPs is to identify patients in need of specific laboratory tests, to improve the patient outcomes taking at the same time into consideration the risk of over-diagnosis and treatment and the available resources as well. To support GPs in their decisional process, we developed a dedicated software application (APP) for mobile devices; the APP contents were developed in collaboration with GPs, with students of a GP training course and with laboratory medicine specialists. We identified the laboratory tests useful for the management of the most frequent diseases observed in GPs&#39; offices,&nbsp; that are supported by the best available evidence. The first attempt was made considering blood hypertension. Aim of the paper is the description of the process of the APP development,&nbsp; that&nbsp; includes data available from national and international guidelines. This promising tool could help GPs to prescribe suitable laboratory tests in different clinical scenario (diagnosis, evaluation of therapy, monitoring) and to promote the implementation of the evidence-based practice of laboratory medicine, reducing the requests of inappropriate tests and accurately identifying patients who need a second level referral (nephrologist, endocrinologist).</p>
Biochimica Clinica ; 43(1) 052-058
Contributi Scientifici - Scientific Paper
Il Grading of Recommendations Assessment Development and Evaluation(GRADE) quale metodologia sistematica e trasparente per valutare l’esame di laboratorio nella formulazione di raccomandazioni e linee guida
The Grading of Recommendations Assessment Development and Evaluation (GRADE) methodology assystematic and transparent framework to evaluate diagnostic test value in supporting guide lines andrecommendations issuing.
<p>A multidimensional pathway based on GRADE Evidence to Decision (EtD) frameworkis presented. The aim of the document is to define a valid process to assess the adoption of a diagnostic test and theconsequences of the decision. The framework includes three sections reflecting the main steps of GRADE EtD:formulating the relevant question, making an assessment of the evidence, and drawing conclusions. As a matter ofexample, the EtD framework is used to present the evidence concerning the molecular diagnosis of sepsis inneonates including seven dimensions: (1) formulating the question; (2) assessment of diagnostic test accuracy; (3)certainty of the evidence; (4) effects of test on the main patient outcome; (5) balance between the desirable andundesirable effects; (6) resource use; (7) equity, acceptability and feasibility. The example is used to better elucidatethe concepts and to show how reviewers may complete each dimension with the relevant information avaiable.Several factors could influence the final decisions: the relevance of the problem, the values of diagnostic accuracy,the effects of the test on main patient outcome; other issues may play a role. The framework consists of acomprehensive decision aid model to ensure that all important criteria are considered to explain a judgment. Thisapproach could help health professionals to use the best available research evidence in a structured and transparentway to inform decisions in the context of laboratory medicine.</p>
Biochimica Clinica ; 43(1) 076-089
Documenti - Documents
Efficacia e utilità del monitoraggio terapeutico di autoanticorpi e farmaci inibitori del Tumor Necrosis Factor alpha in pazienti in trattamento per patologie autoimmuni
Therapeutic monitoring of autoantibodies Tumor Necrosis Factor α inhibitor drugs: efficacy and benefit for patients with autoimmune diseases
<p>Therapeutic monitoring of autoantibodies Tumor Necrosis Factor &alpha; inhibitor drugs: efficacy and benefit for patients with autoimmune diseases. Tumor necrosis factor alpha (TNF&alpha;) is a proinflammatory cytokine involved in the pathogenesis of chronic inflammatory disease, such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Chron&rsquo;s disease and ulcerative colitis. TNF&alpha; inhibitors (anti-TNF&alpha;) are monoclonal antibodies drugs directed against TNF&alpha; (i.e. adalimumab, infliximab, etarnecept, golimumab and certolizumab). Their effect consists in reducing the inflammatory response of autoimmune diseases. Several randomized controlled trials and observational studies evaluated the therapeutic efficacy of these drugs and reported a clear benefit for patients affected by chronic inflammatory disease treated with anti-TNF&alpha;, but also a high risk of reactions and infections in the injection site. These drugs are immunogenic, and consequent anti-drug antibodies (ADA) formation may decrease the functional drug concentration resulting in a loss of response. Therefore, we evaluated the impact of ADA on therapeutic response through meta-analyses, showing that detectable ADA significantly reduced TNF&alpha; inhibitors response. ADA could interfere with drugs and compromise their effects, so the determination of serum ADA levels could improve the patient&rsquo;s management. Even if the decrease of therapeutic response, due to ADA production, is well documented, the clinical benefit of serum ADA determination remains unclear. At the moment, there are many indications about the use of immunogenicity test to guide the therapy, but more information should be acquired before implementing this test in clinical practice.</p>
Biochimica Clinica ; 42(3) 266-273
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
Confronto tra marcatori sierici di fibrosi e biopsia epatica
A comparison between serum biomarkers of fibrosis and liver biopsy
<p>Hepatic fibrosis is a common response to&nbsp;prolonged liver injury and the liver biopsy is the standard method for assessing it. However, searching for alternative&nbsp;noninvasive approaches is important and immunoenzymatic assays using monoclonal antibodies have been recently&nbsp;developed to investigate the diagnostic utility of serum biomarkers. In this study, we explore the relationship between&nbsp;the grade of liver fibrosis and some biochemical parameters. We considered the following markers: collagen IV (CIV),&nbsp;coliglicin (CG), hyaluronic acid (HA), laminin (LN) and aminoterminal procollagen type III peptide (PIIIP). All markers&nbsp;were analyzed by new chemiluminescence immunoassays. We enrolled 36 patients with liver disease and available&nbsp;liver biopsy data. Furthermore, we compared the serum marker concentrations of patients with those of 16 healthy&nbsp;volunteers. Results showed a significant increase in concentrations of CIV, CG and PIIIP in patients with liver fibrosis.&nbsp;For CIV and PIIIP, a significant difference was also observed among groups with different fibrosis grade. In particular,&nbsp;a significant increase was evident in patients with early fibrosis when compared to patients without fibrosis.</p>
Biochimica Clinica ; 39(3) 188-192
Contributi scientifici - Scientific Papers
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