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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

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Via L. Temolo 4, 20126 Milano

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Giuseppe Agosta

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Chiara Riva
Biomedia srl
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ISSN print: 0393 – 0564
ISSN digital: 0392- 7091

BC: Articoli scritti da M. Carta

Il D-dimero nell’esclusione del tromboembolismo venoso nella donna in gravidanza: stato dell’arte
D-dimer in the exclusion of venous thromboembolism in pregnant women: state of the art
<p>The diagnosis of pulmonary embolism (PE) in non-pregnant patients with suspected PE, relies on diagnostic strategies based on sequential assessment of clinical pre-test probability (PTP), determination of plasma D-dimer (DD) levels and diagnostic management: computed tomographic pulmonary angiography (CTPA), pulmonary ventilation/perfusion (V/Q SCAN) and compression ultrasonography (CUS). In pregnant women the use of conventional algorithms for PE is limited by several factors: pregnant women were not included in the studies that derived models assessing PPT of PE, normal pregnancy causes a progressive increase in circulating DD and finally DD levels often exceed non pregnant<!--[if !supportFootnotes]--><span style="font-family:calibri,sans-serif; font-size:11.0pt">[1]</span><!--[endif]-->validated cut-off points, being likely to produce more false positive results. Therefore, guidelines advice against the use of DD determination in pregnancy and recommend to proceed directly to diagnostic imaging. Nevertheless, the clinical presentation of PE can be confused with features of a healthy pregnancy and the prevalence of PE is lower than in non-pregnant population. This leads to a high proportion of negative diagnostic imaging findings. The most recent European Society of Cardiology guidelines, on the basis of two important studies (CT-PE-Pregnancy, ARTEMIS), recognize a possible role of the DD to rule out PE during pregnancy with stratification according PTP and a negative DD result. In the two studies, however, different clinical algorithms and different cut-offs for the DD are used. DD may be a useful diagnostic tool in the management of pregnant women with suspected PE, but further trials are needed to derive and validate models assessing PTP and to identify the optimal DD cut offs during pregnancy.</p>
Biochimica Clinica ; 46(3) S069-S075
Opinioni - Opinions
Il laboratorio nello screening del diabete gestazionale
Laboratory screening of gestational diabetes
M. 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 ; 46(3) S076-S081
Opinioni - Opinions
Interpretazione degli esami relativi all’emostasi in corso di gravidanza
Interpretation of hemostasis tests during physiological pregnancy
<p>Pregnancy is associated with significant modifications of the hemostatic system (endothelium, platelets, coagulation and fibrinolysis) resulting in a prothrombotic state. This is mainly due to an increase in the activity of some procoagulant factors and to the decrease of some physiological inhibitors. The plasma concentrations of these hemostatic system components therefore show important modifications during the three trimesters of pregnancy; as a consequence, the clinical laboratory should report specific reference intervals for the three trimesters of pregnancy or at least add a comment to the laboratory report. The screening tests (although very differently) are also influenced by this hypercoagulability condition and therefore also for PT, APTT, fibrinogen, antithrombin and D-dimer, different reference intervals for the three trimesters of pregnancy should be considered. Global tests have been used (viscoelastometric techniques and thrombin generation test) for monitoring the hemostatic imbalance that occurs during pregnancy; these techniques are very promising but, except for the use of viscoelastometry in monitoring post-partum hemorrhagic risk, they are still far from clinical practice.</p>
Biochimica Clinica ; 46(3) S055-S068
Rassegne - Reviews
How to report HbA1c in presence of hemoglobin variants
How to report HbA1c in presence of hemoglobin variants
<p>Measurement of glycated hemoglobin (HbA1c) has a key-role in the management of diabetic patients. Clinicians need reliable and accurate measurements, with negligible pre-analytical and post-analytical errors. Among the preanalytical variables, the presence of hemoglobin variants is a challenge to the laboratorians, both on pre-analytical and analytical phase. The purpose of this document is to give some practical advices on how to report HbA1c values in presence of hemoglobin variants. This is an update of a previously reported document, published in 2011. The list of the most diffused method for measuring HbA1c has been updated, and the most recent enzymatic assays have been included. A new aspect concerns the post-analytical phase, in which we recommend to report the presence of the hemoglobin variant in the final laboratory report</p>
Biochimica Clinica ; 46(2) 176-179
Documenti SIBioC - SIBioC Documents
Un utile riscontro occasionale di variante emoglobinica
Useful occasional report of a haemoglobin variant.
<p>HbA1c is a marker used for diagnosis and management of diabetes. The clinical case described here describes a patient with Impaired Fasting Glucose who requires the measurement of HbA1c in order to define his metabolic status. The capillary electrophoresis (CE) method used for the HbA1c measurement was unable to return a result for HbA1c because of an atypical pattern which required further investigations. The presence of haemoglobin variants can interfere analytically with HbA1c measurements; also abnormalities in erythrocyte turnover can affect the clinical interpretation of HbA1c values. Therefore, it is important to recognize the presence of a haemoglobin variant, to evaluate whether the result returned from the CE instrument is compatible with the patient&rsquo;s situation.<br />This case demonstrates the importance of implementing safety barriers to prevent errors arising from situations that, although already described and well known, may go unnoticed by the laboratory staff.</p>
Biochimica Clinica ; 46(2) e8-e10
Caso Clinico - Case Report
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
Una variante emoglobinica rara
A rare hemoglobin variant
<p>When arrived to our observation, BS was an African origin newborn of a few days. His hemoglobin concentration and complete blood count were within normal ranges, and he had no jaundice; however, his parents are heterozygous carriers of hemoglobin variant: HbC trait the mother and HbS trait the father. Screening was therefore required for hemoglobin variants. The request is appropriate since the evidence of a double heterozygosis S/C (SCD) would allow timely treatment of these patients. Screening was performed in capillary electrophoresis but was not conclusive because the presence of a small concentration of HbS and of another variant did us not allow to make a diagnosis, although the presence of HbA allowed to exclude the state of SCD. Hemoglobin electrophoresis was then performed, but it was not conclusive. It was necessary resorting to the molecular analysis, that highlights the presence of HbS trait and a mutation in heterozygosis at the charge of the gamma-globin chain consistent with HbF Granada. The recognition of HbF Granada was meaningless from a clinical point of view, but allowed to exclude the presence of a hemoglobin compound, the main clinical question of this clinical case.</p>
Biochimica Clinica ; 44(3) e020-e022
Casi Clinici - Case Report
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
La tele-ematologia nel consolidamento dei laboratori clinici
Tele-haematology in the consolidation of clinical laboratories
D. Giavarina  |  M. Carta  | 
<p>Haematological laboratory diagnostics couldbenefit widely from telematics, but some critical issues need to be addressed for a successful organization. Imagetransmission is probably the most critical item. In fact, specific competences are required for the selection of thesamples to be reviewed, preparing of the slides, choosing fields and cells to be examined, and so on. Thetransmission of the entire blood film could be a good solution, but it is not yet available for laboratory haematology,while expert automated systems are nowadays ready for high performance processes without the need of specificskills.<br />Digitization of laboratory haematology can harmonize the activities utilizing the same rules of selection of thepreparations to be reviewed, and for the control, verification and validation of the analysed samples and finally forreporting. It offers support for consultancy and training. When these needs involve different sites far from each other,the transmission of data and images effectively requires automation technologies for preparing and reading thepreparations, information technologies for an integrated management of all the necessary data helpful for thediagnosis and a suitable network to make communications travel in suitable quantities and speeds.<br />The new frontiers of artificial intelligence will probably have a greater role both in the management of process, in theverification of automatic validations, and finally in the recognition of pathological morphological patterns. All this toolscannot replace the specialized expertise in the final supervision of haematological diagnoses, but will allow simpler,faster and safer management of haematological analyses and revisions, meeting the changing needs of modernlaboratory medicine.</p>
Biochimica Clinica ; 43(2) 125-134
Rassegne - Reviews
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
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
Raccomandazioni 2015 per l’esecuzione dell’esame da carico orale di glucosio
2015 recommendations for oral glucose tolerance testing (OGTT)
M. Carta  |  A. Mosca  |  A. Lapolla  |  R. Testa  | 
<p>Despite its large use and importance, OGTT is&nbsp;still plagued by poor reproducibility and sometimes is not appropriately performed. In 2006 the joint Study Group on&nbsp;Diabetes mellitus made recommendations concerning OGTT in order to harmonize the test procedure according to&nbsp;WHO and American Diabetes Association guidelines. This document should be regarded as an updated version of the&nbsp;original 2006 recommendations, including some improvements and changes, particularly regarding the use of OGTT for&nbsp;the diagnosis of gestational diabetes in agreement with the 2010 guidelines of the Italian Ministry of Health. The list of&nbsp;drugs having effect on the glucose tolerance has been updated too.</p>
Biochimica Clinica ; 39(2) 135-140
Documenti SIBioC - SIBioC Documents
Refertazione dell'emoglobina glicata in presenza di varianti emoglobiniche
Glycated hemoglobin reporting in presence of hemoglobin variants
M. Carta  |  A. Mosca  | 
Biochimica Clinica ; 35(1) 42