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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

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

Responsible Editor
Giuseppe Agosta

Editorial Secretary
Andrea di Bello
Biomedia srl
Via L. Temolo 4, 20126 Milano
Tel. 0245498282


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

BC: Articoli scritti da L. Sciacovelli

Cinetica e caratteristiche biologiche della risposta umorale all’infezione da SARS-CoV-2: implicazioni vaccinali
Kinetics and biological characteristics of humoral response developing after SARS-CoV-2 infection: implications for vaccination
<p>With the ongoing coronavirus disease 2019 (COVID-19) pandemic outbreak spreading all around the world, an extensive vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is now universally regarded as one of the most effective strategies for counteracting the unremittent spread of this novel coronavirus. Nonetheless, the reasonable need to identify segments of the population in which vaccination shall be prioritized for avoiding a possible shortage of vaccines seems to collide with indications provided by many national and international healthcare organizations, that endorse widespread vaccination irrespective of a positive history of prior symptomatic or asymptomatic SARS-CoV-2 infection. To this end, this document provides an ad interim guidance aimed at prioritizing SARS-CoV-2 vaccination in people who are more likely to be infected, re-infected and/or to develop more aggressive COVID-19 illness, essentially based on routine assessment and monitoring of anti-SARS-CoV-2 immune response.</p>
Biochimica Clinica ; 45(1) 087-090
Documenti SIBioC - SIBioC Documents
Raccomandazioni ad interim di SIBioC per l’analisi sierologica dell’infezione da SARS-CoV-2
Ad interim SIBioC recommendations for serological assessment of SARS-CoV-2 infection
<p>The recent pandemic outbreak caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and associated with the pathology called COVID-19 (coronavirus disease 2019), has now become one of the most strenuous health care challenges since the emergence of the three pandemics caused by influenza viruses during the past century. Throughout the clinical decision-making of COVID-19, laboratory tests are essential for supporting the screening, diagnosis, prognostication and therapeutic monitoring of this severe infectious disease. Serological testing, that reflects the humoral immune response developing after interaction between the host and the virus (or its components), enables to garner a vast array of clinical information which can be especially used in seroprevalence or seroconversion studies. To this end, the Task Force on COVID-19 of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) has endorsed a series of technical, practical and clinical ad interim recommendations, aimed at facilitating and optimizing the introduction, clinical usage and governance of SARS-CoV-2 serological immunoassays in routine practice.</p>
Biochimica Clinica ; 45(1) 091-099
Documenti SIBioC - SIBioC Documents
52° Congresso Nazionale: Virtual Edition
Biochimica Clinica ; 44(3) 321
Notizie SIBioC - SIBioC News
Valutazione precoce del danno cardiaco da farmaci chemioterapici: importanza della misura delle troponine cardiache I e T con metodi ad alta-sensibilità analitica
High-sensitivity cardiac troponin I and T methods for the early detection of myocardial injury in patients on chemotherapy
<p>Important advances achieved in pharmacological cancer treatment have led progressively to a reduction in mortality from many forms of cancer, and increasing numbers of previously incurable patients can now hope to become cancer-free. Yet, to achieve these improved outcomes a high price has been paid in terms of untoward side effects associated with treatment, cardiotoxicity in particular. Several recent studies have reported that cardiac troponin assay using high-sensitivity methods (hs-cTn) can enable the early detection of myocardial injury related to chemotherapy or abuse of drugs that are potentially cardiotoxic. Several authors have recently suggested that changes in hs-cTn values enable the early diagnosis of cardiac injury from chemotherapy, thus potentially benefitting cancer patients with increased troponin values by initiating early cardioprotective therapy. However, large randomised clinical trials are needed in order to evaluate the cost/benefit ratio of standardised protocols for the early detection of cardiotoxicity using the hs-cTn assay in patients treated with chemotherapy.</p>
Biochimica Clinica ; 44(3) 279-286
Documenti SIBioC - SIBioC Documents
Garantire la comparabilità dei risultati nel rispetto dei requisiti di qualità e delle esigenze organizzative: l’esempio di una procedura operativa
How to guarantee the comparability of test results in compliance with the quality requirements andorganizational needs: the example of an operative procedure
<p>Medical laboratories are responsible for the qualityof test results, also when the same patient sample is evaluated using different analytical systems within the same lab.Indeed, as stated by ISO 15189:2012, laboratories should define means to compare procedures for evaluating thecomparability of patients&rsquo; samples results within the same healthcare system. In this study we report the approachused to define a procedure for assessing results comparability, developed in our laboratory before the ISO15189:2012 accreditation in 2016. Firstly, the approach was focused on the identification of all the different situationsthat may potentially require alignment of test results within the laboratory. Therefore, after evaluating guidelines anddocuments available in the literature, we defined a workflow applicable both to quantitative and qualitative methods.For quantitative methods, bias was estimated by means of statistical analyses such as Bland Altman and PassingBablok. For qualitative methods, results comparability was assessed by concordance. Criteria for defining theacceptability of systematic errors were also included in the procedure.</p>
Biochimica Clinica ; 43(2) 135-142
Contributi Scientifici - Scientific Papers
La valutazione delle prestazioni analitiche dei laboratori mediante programmi di valutazione esterna di qualità: una analisi multifattoriale
The evaluation of laboratories’ analytical performance through external quality assessment programs: amultifaceted analysis
<p>The Italian accreditation body, Accredia, requires that clinical laboratories obtained positiveanalytical performances in the last four External Quality Assessment (EQA) surveys in order to undertake theaccreditation with flexible scope (document RT-26).<br />In addition to the choice of acceptability limits (AL), other factors contribute to define the analytical performance:nature and commutability of control materials, definition of target value (TV), homogeneous group classification, dataelaboration, procedures for outliers exclusion.<br />In this study, the creatinine performances of 106 participants, obtained in the last four surveys of the year 2017 ofthe Centre of Biomedical Research (CRB) EQA program, have been evaluated using two different AL and TV: the ALproposed by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and by the RegionalReference Centre of the Azienda Ospedaliera Universitaria &ldquo;Careggi&rdquo; of Firenze (Italy) (CRRVEQ); the TV assignedwith the reference method (RV) and as consensus value, i.e. median of the results obtained with the same method(AV).<br />The percentage of laboratories satisfying the RT-26 requisite was different on the basis of the AL and TV considered:with the EFLM-AL, 68.8 % laboratories complied the requisite if AV was used and 60.4% if RV was applied; with theCRRVEQ-AL, 50.0% and 48.1%, respectively.<br />These data demonstrate that harmonized criteria and procedures for evaluation of EQA results are needed to obtainhomogeneous classification of laboratories&rsquo; performance.<br />In order to support the laboratory professionals in accreditation processes and, above all, to guarantee theirperformance reliability, time has come that the Scientific Societies of Laboratory Medicine promote the merging of thedifferent Italian EQA schemes in a consolidated network of EQA providers.</p>
Biochimica Clinica ; 43(2) 168-172
Opinioni - Opinion
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
La check list in medicina di laboratorio quale strumento di assicurazione della qualità e sicurezza del paziente: l'esempio del prelievo venoso
Check-list in laboratory medicine: an important tool to improve patient safety. The blood collection
A. Aita  |  R. Marin  |  C. Pozzato  |  E. Piva  |  L. Sciacovelli  |  M. Plebani  | 
<p>This work aims to describe the results concerning the implementation of a check-list (CL) on blood collection procedures as a tool to prevent errors in laboratory medicine. Literature and operating procedures carried out in three outpatients phlebotomy sites (SMa, SMb, PN) were analysed to identify check-points (CPs). CL draft was evaluated by a multidisciplinary team and tested for one month (September 2014) by 25 physicians and 15 nurses. The filled in CLs were analysed together with the involved staff and a final version was released. CL effectiveness was evaluated immediately after experimentation and one year later. 5661 CL were filled in, out of 9469 venipunctures (59.8%). The percentages of CPs filled in within SMa, SMb and PN were respectively: 100% patient identification and label-sample-identification matching; 80.2, 73.1 and 51.9% vein selection; 96.7, 95.8 and 97.9% needle selection; 82.5, 85.8 and 89.9% tourniquet application time; 98.9, 97.9 and 98.7% tubes filling; 98.4, 97.4 and 98.7% tubes mixing; 27.6, 23.5 and 15% temperature transport; 16.4, 20.8 and 1.3% time transport. The percentages of unsuitable samples in SM and PN were respectively: 0.040 and 0.013% (September 2014); 0.041 and 0.012% (October 2014); 0.024 and 0.16% (September-October 2015). The insufficient number of available CLs, difficulties over communication concerning purpose and methodology, and patients crowding affected the results in SM; anyway the CL was very helpful for trainees. An effective CL should: include only critical CPs, be shared with the staff, take into account organizational peculiarities. CL is a powerful tool to ensure patient safety only when it becomes an integral part of quality management system.</p>
Biochimica Clinica ; 42(2) 131-140
Contributi Scientifici - Scientific papers
Armonizzazione della notifica dei valori critici come contributo al miglioramento della sicurezza e della cura del paziente
Harmonization of the notification of critical values as contribution to the improvement of patient safety and care
<p>A project for harmonizing the notification of critical values was performed in our department, which covers 3&nbsp;different hospitals. We achieved the harmonization of definitions by distinguishing critical values, critical tests and&nbsp;abnormal results, according to the Joint Commission proposal. For critical tests, the requesting physicians should&nbsp;verify the availability of results as soon as possible, while the laboratory professionals must ensure appropriate and&nbsp;timely results. As an example, all requests from the Emergency Room are relevant and considered as critical tests,&nbsp;avoiding overload of alarms or calls, which distract the busy medical team. Identification of critical values was based&nbsp;on consensus, guidelines and clinicians&rsquo; opinion. The practice was harmonized by automated notification systems&nbsp;and by establishing who should report critical values on an established time frame to the responsible licensed&nbsp;caregiver, so that the patient can be promptly treated. Timeliness was linked with clinical effectiveness with the aim<br />to provide the best outcome at the lowest cost. Finally, harmonization was directed to develop quality indicators&nbsp;regarding the policies of critical value communication, the monitoring of the timeliness in reporting and the need to&nbsp;evaluate how the effectiveness of improved communication assures better clinical outcomes. The realization of&nbsp;harmonized critical value notification may support the clinical decision making, leading to an improvement in patient&nbsp;safety and care.</p>
Biochimica Clinica ; 39(6) 595-600
Contributi scientifici - Scientific Papers
Gli indicatori di qualità nel processo di armonizzazione in Medicina di Laboratorio
Harmonization of quality indicators in Laboratory Medicine
<p>According to the International Standard for medical&nbsp;laboratories accreditation ISO 15189:2012, the laboratory should establish and periodically review quality indicators&nbsp;(QIs) to monitor and evaluate performance throughout critical aspects of pre-, intra and post-analytical processes.&nbsp;The use of QIs is needed to provide information and accountability to users and to establish a program of continuous&nbsp;improvement to ensure the quality of care and patient safety. In this context, we designed a QIs system as a part of&nbsp;a coherent and integrated quality improvement strategy. The management of QIs is based on an internal assessment&nbsp;system (IAS), which allows us to evaluate our performance over time and on the participation in an interlaboratory&nbsp;comparison managed as an EQA program, in order to compare our performance with other laboratories. The IAS&nbsp;includes a list of QIs, a form describing the specifications of each QI and a standard operating procedure. We&nbsp;participated in the project developed by the Working Group &ldquo;Laboratory errors and patient safety&rdquo; of IFCC on QIs.&nbsp;The project aims to identify a model of QIs that can be used worldwide through an EQA program. This paper aims to&nbsp;stimulate harmonization initiatives concerning QIs on the basis of the method and results of described experience.</p>
Biochimica Clinica ; 39(6) 601-608
Contributi scientifici - Scientific Papers
Linee guida per la gestione dei programmi di Valutazione Esterna di Qualità
Guidelines for External Quality Assessment Scheme organization
Biochimica Clinica ; 35(2) 107
Il Percorso Comune di Formazione per Specialisti in Medicina di Laboratorio secondo la Direttiva Europea 2013/55/EC (Il riconoscimento delle qualifiche professionali)
A proposed common training framework for specialists in laboratory medicine under EU directive 2013/55/EC (The recognition of professional qualifications)
<p>European Union (EU) Directive 2013/55/EC (The Recognition of Professional qualifications) allows Member States to decide on a common set of minimum knowledge, skills and competences that are needed to pursue a given profession through a Common Training Framework. To be adopted the framework must combine the knowledge,skills and competences of at least one third of the Member States. Professionals who have gained their qualifications under a Common Training Framework will be able to have these recognised automatically within the Union. Thebackbone of the European Federation of Clinical Chemistry and Laboratory Medicine&rsquo;s (EFLM) proposed Common Training Framework for non-medical Specialists in Laboratory Medicine is outlined here. It is based on an Equivalence of Standards in education, training, qualifications, knowledge, skills, competences and the professional conduct associated with specialist practice. In proposing the recognition of specialist practice EFLM has identified 15 EU Member States able to meet Equivalence and in whom the profession and/or its training is regulated (an additional EU Commission requirement). The framework supports and contributes to the Directive&rsquo;s enabling goals for increasing professional mobility, safeguarding consumers and ensuring a more equitable distribution of skills and expertise across the Member States. It represents EFLM&rsquo;s position statement and provides a template for professional societies and/or competent authorities to engage with the EU Commission.</p>
Biochimica Clinica ; 17(1)
Documenti SIBioC - SIBioC Documents
Modalità di refertazione del D-Dimero e prestazioni dei sistemi analitici: quali informazioni dal programma di Valutazione Esterna di Qualità del Centro di Ricerca Biomedica
Reporting of D-Dimer and performance of analytical systems: data from participants to the External Quality Assessment Scheme of the Biomedical Research Centre in Italy
<p>Introduction: D-Dimer assessment represents a cornerstone in the diagnostic approach to several thrombotic disorders. Recent literature has highlighted the role of D-Dimer also in the diagnostic pathway of coronavirus infection (COVID-19) and the importance of harmonized reporting [D-dimer unit (DDU) or fibrinogen equivalent unit (FEU); unit of measure; cut-off] in order to guarantee the correct interpretation of the results.<br />Methods: D-Dimer data from 100 EQA participants and the inter-laboratory variability (CV%) of the last 7 years for the most used analytical systems: Werfen, HemosIL HS; Werfen, HemosIL HS-500; Auto D-D, Sclavo; Innovance, Siemens; VIDAS, bioM&eacute;rieux and STA Liatest, Stago have been evaluated.<br />Results: concerning the results expression in DDU or FEU, we observed a prevalence of FEU (55.1%) over DDU (44.9%); the value was confirmed in the last 7 years (average FEU = 55.6%), differently from data obtained in the survey conducted in 2014 at a national level.<br />The units used are: ng/mL (67.8%), &mu;g/L (29.0%) and mg/L (3.2%) for D-Dimer DDU; ng/mL (57.9%), &mu;g/mL (21.0%), &mu;g/L (15.8%) and mg/L (5.3%) for D-Dimer FEU.<br />Inter-laboratory variability (mean CV%) calculated on a total of 72 controls is lower for all diagnostic systems at pathological levels than the one observed for concentrations below the cut-off.<br />Discussion: this study demonstrates that the reporting of D-Dimer results does not comply with the 2014 SIBioC consensus document which recommended the use of &mu;g/L FEU, and highlights 8 different types of information. Data reported in this study call for the harmonization of D-Dimer reporting in order to guarantee the correct interpretation of the information, both in the case of COVID-19 and in all the diseases already known where this analyte has a clinical relevance.</p>
Biochimica Clinica ; 17(1)
Contributi Scientifici - Scientific Papers