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Maria Stella Graziani

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

BC: Articoli scritti da G. Patrucco

Principi per l’implementazione e la gestione del point-of-care-testing (POCT): indicazioni essenziali
Implementation and management of the point-of-care testing (POCT): essential indications
<p>In recent years, the field of medicine has considerably changed; an important, widespread trend is the reorganization of medical laboratories. These facilities made an effort to improve their efficiency through a process of consolidation and decentralization. In this context, Point-of-Care Testing (POCT) devices offer numerous advantages, but also pose a clinical risk, particularly in Italy, which is limited by its varied, often inadequate, regional regulations. Some examples are reported, representing scenarios of frequent or bothersome POCT use. This document outlines the SIBioC Working Group recommendations for the safe use of POCT instruments. It defines how these have been updated to the state of technologies and medical requirements. Particular attention has been paid to clinical governance, connectivity, the role of the laboratory director and staff, quality control, education, risk management and the role of the in vitro diagnostic companies. Most of the Italian medical practice is based on hospital experience, but the recent pandemic outbreak of SARS-CoV-2 forces us to re-think about the use of POCT in settings that are outside of the hospital such as local clinics, nursing homes and primary care facilities. These facilities will be the next important field of application for those indispensable tools. Networks of instruments, professionals and competence should be carefully tailored to meet local needs and specific clinical settings.</p>
Biochimica Clinica ; 45(3) 312-326
Documenti SIBioC - SIBioC Documents
Il calcolo del kappa index come valida alternativa alla determinazione delle bande oligoclonali nell’iter diagnostico dei pazienti con sclerosi multipla
The Kappa Index as a valid alternative to oligoclonal bands determination in the diagnostic process of patients with multiple sclerosis
<p>Introduction: the role of the kappa free light chains (KFLC) index in the diagnostic workup of multiple sclerosis (MS) is still a matter of debate.<br />Methods: 667 subjects from three reference laboratories have been enrolled, including 181 MS patients and 486 controls with other immune-mediated or non-inflammatory disorders. Serum and cerebrospinal fluid KFLC index, serum and cerebrospinal fluid albumin and IgG concentrations were measured on BNII nephelometer (Siemens Healthineers. Marburg. Germany), while oligoclonal bands (OCB) were detected by isoelettrofocusing on Hydrasys system (Sebia. Bagno a Ripoli. Italia).<br />Results: KFLC index was higher in MS than in controls [median (interquartile range - IQR) 76.56 (35.05) versus 17.99 (2,34), p &lt;0.001]. A cut-off of 5.0 resulted in 93.9% (min-max 82.6-96.0) sensitivity and 77.4% (70.3-80.3) specificity, with positive and negative predictive values of 60.7% (41.4-69.3) and 97.2% (93.6-98.0), respectively. OCB assessment yielded 94.6% (87.9-96.5) sensitivity and 91.4% (86.6-94.8) specificity, with positive and negative predictive values of 87.5% (78.6-92.0) and 96.4 (93.6-98.0), respectively. The three laboratories showed similar results, making it possible to adopt common thresholds. The relatively low specificity of KFLC may be related to the characteristics of the control population, in particular to the percentage of subjects with inflammatory conditions associated with intratechal immunoreactivity.<br />Conclusions: an algorithm for the diagnostic management of MS could be suggested based on the KFLC index as screening test, followed by the detection of OCB, in case of a positive result. Future studies are needed to evaluate possible relationships between KFLC index, as a quantitative variable, and other clinical features of MS, such as severity of the disease and prognostic scores.</p>
Biochimica Clinica ; 45(1) 044-051
Contributi Scientifici - Scientific Papers
Analisi di laboratorio in un Punto di Primo Intervento: l’esperienza di sei anni di Point-of-Care Testing
Diagnostic test in a First Aid Point Service: a six years Point-of-Care Testing experience
G. Micca  |  G. Patrucco  | 
<p>For many yearslaboratory medicine services have been focused on reorganization interventions aimed at improving efficiency, inorder to respond to new care needs and to reduce costs. In some situations, when the centralized laboratory is notable to guarantee the service with an adequate timeliness, a Point-Of-Care Testing system designed for the clinicalmanagement of critically ill patients could be the solution. These systems can guarantee the immediate availability ofdiagnostic tests for diagnosis, monitoring and therapy, both for critical ill patients and for the continuity of health-care.<br />In this paper a six years&rsquo; experience of a Point-of-Care Testing implementation and management is described in aFirst Aid point service, in a particular territorial health-network created to guarantee continuity between the referencelaboratory and the local hospitals.</p>
Biochimica Clinica ; 43(2) 143-149
Contributi Scientifici - Scientific Papers
Disposizioni normative in Italia per la gestione dei Point of Care Testing: un’indagine SIBioC nelle regioni italiane
Regolatory rules for the Point of Care Testing in Italy: a survey of the Italian Society of Clinical Biochemistry
<p>Regolatory rules for the Point of Care Testing in Italy: a survey of the Italian Society of Clinical Biochemistry. Point-of-care testing (POCT) is a form of laboratory testing aimed to perform the analysis where healthcare is provided, close to or near the site of the patient care. It is a very common mode of providing laboratory testing, but concerns over the quality and errors of POCT have emerged from various sources. Regulations in different Countries and POCT operational guidelines have been produced by many professional groups and stakeholders, with the scope of minimizing testing errors and to built an efficient process. Since a national regulatory rule is lacking in Italy, a survey on the available local regulations has been conducted by the study group on POCT of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology in all the Italian Regions; the results are reported in the present paper. Local regional rules are rather divergent: some of them contain only essential indications while others are too detailed and difficult to apply. The lack of harmonization and regulation among Italian regions makes necessary the issuing of a national rule aimed to minimize the problems associated with POCT management to deliver to patients the best outcome</p>
Biochimica Clinica ; 42(4) 313-317
Contributi Scientifici - Scientific Paper