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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
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Tel. 0245498282


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

BC: Articoli scritti da G. Bonetti

Adesione alle raccomandazioni dei gruppi di studio SIBioC-SIPMeL (Società Italiana di Patologia Clinica e Medicina di Laboratorio) e SID (Società Italiana di Diabetologia) sulla fase preanalitica per la determinazione della glicemia: ancora margini di miglioramento. Risultati di una indagine conoscitiva nazionale
Adherence to the recommendations of the SIBioC-SIPMeL (Società Italiana di Patologia Clinica e Medicina di Laboratorio) and SID (Società Italiana di Diabetologia) study groups on the preanalytical phase for blood glucose measurement: still room for improvement. A National Survey on the state of art.
A. Terreni  |  M. Carta  |  D. Giavarina  |  V. Miconi  |  A. Mosca  |  G. Bonetti  | 
<p>Introduction: glucose measurement is pivotal in the management of subjects with diabetes mellitus. Laboratories should provide the most useful information to the clinician in order to ensure the best patient outcome.<br />Methods: in October 2019 a survey has been conducted by SIBioC and SIPMeL Study Groups on &ldquo;Diabetes Mellitus&rdquo; and by the Italian Diabetes Society to verify if their recommendations on preanalytical phase have had an impact on Italian laboratory procedures. Fifteen questions were submitted to all SIBioC and SIPMeL members and 190 complete responses were collected, corresponding to around 5% of all Italian laboratories.<br />Results: 74% of the laboratories (n=46) are aware of the recommendations of the &ldquo;Diabetes Mellitus&rdquo; Study Groups, but only 24% apply them. 61% of the first group centrifuges the collection tubes immediately, providing a rapid plasma separation; 9% place the tubes immediately in an ice-water slurry and separate the plasma within 30 minutes. Only 14 of the responders use citrate buffer/sodium EDTA/sodium fluoride (NaF) tube in lyophilic formulation.<br />The survey allowed to determine also which kind of tube is commonly used: for outpatients, 52 (30%) laboratories use serum or heparinized tubes with separator gel, 46 (24%) of the remaining of laboratories use NaF plasma and heparinized plasma tubes. For hospitalized patients, 99 (52%) laboratories utilizes tubes with separator gel or coagulation activator, while 19 (10%) and 15 (8%) respectively use NaF plasma and heparinized plasma. To perform the Oral Glucose Tolerance Test (OGTT), 84 (43%) laboratories uses tubes without glycolysis inhibitors or separator gel, and only 12 laboratories uses tubes with acidified ternary mixture.<br />Conclusion: considering these non-completely satisfactory findings, the educational activity of SIBioC working groups on &ldquo;Diabetes Mellitus&rdquo; and &ldquo;Variability of Extra-analytical phase&rdquo; should be continued, since they appear to be essential for the improvement of the laboratory procedures.</p>
Biochimica Clinica ; 45(3) 248-257
Contributi Scientifici - Scientific Papers
Il tipo di campione per la curva da carico orale di glucosio è fondamentale per una corretta identificazione del diabete mellito gestazionale
An appropriate sample for oral glucose tolerance test is fundamental for a correct identification of gestational diabetes mellitus
<p>Background: Gestational Diabetes Mellitus (GDM) is diagnosed by the oral glucose tolerance test (OGTT) using Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) study-derived definite cut-off values, where reference glucose is determined in sodium fluoride (NaF) containing tubes immediately centrifuged. The aim of the present study is to evaluate the effect of the use of the recommended citrate containing tubes, as immediate glycolisis inhibitor, for OGTT as screening for GDM, comparing them with NaF containing tubes, used in routine laboratory conditions.<br />Methods: a total of 83 pregnant women were enrolled in the study; OGTT (75 g) was carried out in the Clinical Laboratories of Brescia and Vicenza in all the subjects for screening of GDM. All subjects signed written informed consent to participate in the study. Glucose determination was performed using three different types of glycolysis inhibitor: [sodium fluoride (NaF, in both laboratories), a lyophilized acidified mixture (FC-MIX, in Vicenza), and a liquid acidified mixture (GlucoEXACT, in Brescia)]. The glucose concentration was measured by an hexochinase method on Dimension Vista systems from Siemens Healtheers. The International Association of Diabetes and Pregnancy Study Groups (IAPDGS) criteria, derived from the HAPO study, were used for the diagnosis of GDM.<br />Results: Using NaF and FC-mix tubes, 6/51 (11.8%) and 12/51 (23.5%) women respectively, were diagnosed having GDM in Vicenza. Using NaF and GlucoEXACT tubes 2/31 (6.5%) and 6/31 (18.8%) women respectively, were diagnosed having GDM in Brescia. There was a statistically significant difference (p&lt;0.05) between NaF and citrate acidified mixture in the glucose measurements at all time points.<br />Conclusions: The use of the tubes containing a mixture of NaF, EDTA and citrate is a useful and necessary pre-analytical tool for an accurate OGTT, when utilized for the screening of GDM. Tubes containing NaF alone should no longer be used for screening of GDM because their use results in underdiagnosis of GDM.</p>
Biochimica Clinica ; 44(2) 143-148
Contributi Scientifici - Scientific Papers
Impatto delle variabili preanalitiche e analitiche sulla diagnosi di diabete melito gestazionale
M. Carta  |  D. Giavarina  |  G. Bonetti  | 
Biochimica Clinica ; 44(2) 206-208
Lettere all'Editore - Letters to the Editor
Pazienti diabetici di tipo 2, non in terapia insulinica e albumina glicata: una valutazione multidimensionale
Insuline-Naive type 2 diabetic patients: a multidimensional evaluation on the role of glycated albumin
<p>Insuline-Naa&iuml;ve type 2 diabetic patients: a multidimensional evaluation on the role of glycated albumin Introduction: glycated Albumin (GA) is an innovative glycemic marker, that could be used in the clinical practice, as an add-on strategy, to the traditional glycemic monitoring systems, such as glycated haemoglobin (Hb1Ac) and fasting plasma glucose (FPG). The study aims at presenting the results of a multidimensional analysis conducted in Italy, exploring the main clinical, economic, ethical, social and organizational implications, related to the introduction of GA. Methods: an Health Technology Assessment (HTA) approach was implemented. The analysis considered the Italian National Healthcare Service (NHS) perspective, and assumed a 12-month time horizon, focusing on type 2 diabetes patients insulin-na&iuml;ve, assuming oral therapy. The 9 HTA dimensions (derived from the Core Model developed by the European Network of HTA &ndash; EUnetHTA) were deployed, considering scientific evidence, health economics tools and qualitative approaches, through the administration of specific questionnaires to 15 diabetes experts. Results: literature reported better GA safety and efficacy profiles, thus being a predictor of the relative risk for diabetes complications development, and increasing the therapeutic success after 3 months of therapy (97.0% versus71.6%). From an economic point of view, GA introduction resulted in an economic advantage of 1.06% and in a better trade-off between costs sustained and efficacy gained. Considering a 7-item Likert Scale (ranging from -3 to +3), negative perceptions emerged with regard to equity aspects (0.13 versus0.72) due to GA limited accessibility, whereas it would improve both patients (2.17 versus1.33) and care givers (1.50 versus0.83) quality of life. In the short term, GA required training courses and equipment update, whereas, in the long term, it could be considered the preferable solution from an organizational perspective (0.30 versus0.01). Conclusions: the results of this study demonstrated GA strategic relevance, its economic sustainability and feasibility, as well as the potential clinical pathway improvement.</p>
Biochimica Clinica ; 44(1) 052-060
Contributi Scientifici - Scientific Papers
Interferenza da biotina negli immunodosaggi: raccomandazioni del Gruppo di Studio SIBioC sulla Variabilità Extra-Analitica (SIBioC-VEA)
Biotin interference in immunoassays: recommendations of the SIBioC Working Group on Extra-AnalyticalVariability (WG-VEA).
<p><span style="background-color:rgb(255, 255, 255); color:rgb(51, 51, 51); font-family:sans-serif,arial,verdana,trebuchet ms; font-size:13px">Biotin is a water-soluble vitamin, which participates to a vast array of metabolic pathwaysinvolving fatty acids, carbohydrates and amino acids metabolism. This vitamin is also capable to form high-affinitybonds with various molecules, including streptavidin and avidin, which are essential components of manyimmunoassays based on the principle of biotin-streptavidin or biotin-avidin binding. In patients assuming high dosesof biotin, therefore, some competitive and non-competitive immunoassays may exhibit falsely increased and falselydecreased test results, respectively, with magnitude of interference depending on biotin concentration in the testsample and on specific vulnerability of the immunoassay. With the aim to provide some expert guidance foridentifying, preventing and managing biotin interference in clinical laboratory practice, this document contains a seriesof consensus recommendations endorsed by the Working Group on Extra-Analytical Variability of the Italian Societyof Clinical Chemistry and Clinical Molecular Biology (SIBioC). Briefly, the most important recommendationsencompass local evaluation of possible biotin interference, routine history taking on biotin intake for both inpatientsand outpatients, informing clinicians on potentially biotin-sensitive immunoassays, sample retesting 24-48 hours afterthe last biotin administration, along with possible consideration to add a note in the laboratory report highlighting themethods more vulnerable to biotin interference. Routine biotin measurement in all samples is currently discouraged.</span></p>
Biochimica Clinica ; 43(3) 327-331
Raccomandazioni per l’ottimizzazione della fase pre-analitica per una corretta determinazione della glicemia in ambito diabetologico
Correct determination of glycemia in the management of diabetes: recommendations for the optimization of the pre-analytical phase
G. Bonetti  |  M. Carta  |  A. Lapolla  |  R. Miccoli  |  R. Testa  |  A. Mosca  | 
<p>The time-dependent decrease of glucose in tubes after venipuncture may cause artificially lower values, if glycolysis is not appropriately inhibited by the correct anticoagulant. In this work we have extensively reviewed the current literature about the possible use of citrate buffer together with sodium EDTA and sodium fluoride. We conclude that, for screening and diagnosis of diabetes mellitus, including gestational diabetes, glucose has to be determined in plasma by using the above mentioned ternary mixture either as solid or in liquid state (in this case the correct numerical conversion factor has to be employed). For the measurement of glucose in patients with already known diabetes and following monitoring, lithium heparin tubes may be used providing that plasma separation should be rapidly performed. Alternatively, serum-separating tubes with particles promoting rapid clotting could also be employed.</p>
Biochimica Clinica ; 42(3) 263-265
Documenti SIBioC - SIBioC 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
Inibizione della glicolisi e accuratezza preanalitica nella misura della glicemia: la posizione del Gruppo di Studio SIBioC-SIPMeL Diabete Mellito
Glycolysis inhibition and reliable plasma glucose results: the position of the SIBioC-SIPMeL Study Group on Diabetes Mellitus
Biochimica Clinica ; 39(3) 223-224
Lettere all'Editore - Letters to the Editor
Il laboratorio nello screening del diabete gestazionale
Laboratory screening of gestational diabetes
MR Carta  |  D. Giavarina  |  G. Bonetti  | 
<p>Gestational diabetes mellitus (GDM) is defined by glucose intolerance first documented during pregnancy. The oral glucose tolerance test (OGTT) is currently the gold standard for the diagnosis of gestational diabetes mellitus, but many variables can affect its reproducibility and accuracy. An important source of pre-analytical variation affecting the glucose values is the type of tube employed for blood collection. Experts recommend immediately separation of the plasma from the cells by centrifugation, or to place the sample tube in an ice-water slurry and separate the plasma from the cells within 30 minutes from blood drawing. Being this approach impractical in daily practice, the use of a blood collection tube containing effective glycolysis inhibitors is a good alternative to avoid the decrease of plasma glucose concentration after blood drawing. Considering that the GDM diagnosis is based on cut off values, the use of tubes for blood collection that limit the in vitro glycolysis, could lead to an increase of the GDM prevalence. The impact of the increase is potentially of clinical significance: it is therefore fundamental that clinicians are aware of the main causes of preanalytical variability and how these variables can affect the patients&rsquo; outcome. A strict collaboration between the clinical laboratories and clinicians should therefore be started and maintained.</p>
Biochimica Clinica ; 17(1)
Opinioni - Opinions