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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

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Francesco Busardò

International Advisory Board Khosrow Adeli Canada
Sergio Bernardini Italy
Marcello Ciaccio Italy
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Philippe Gillery France
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Hans Jacobs The Netherlands
Eric Kilpatrick UK
Magdalena Krintus Poland
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Giuseppe Agosta

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

BC: Articoli scritti da D. Brugnoni

Elementi utili per implementare un sistema per il controllo dell'accuratezza dei risultati nella diagnostica di SARS-COV-2 (RNA virale, antigeni e anticorpi)
Useful elements for implementing a system to control the accuracy of results in the diagnosis of SARS-CoV-2 (viral RNA, antigens and antibodies)
<p>As SARS-CoV-2 swiftly spread globally becoming a pandemic, the urgent need to provide a laboratory diagnosis of the infection - to allow both the clinical management of individual patients and to monitor the outbreak in the community by health authorities - arose. This resulted in a rapid development of diagnostic tests - promptly available on the market - including methods for the direct detection of the virus in biological samples (molecular and antigenic tests) and for indirect detection by documenting a contact with SARS-CoV-2 (serological antibodies tests). To fast-track the availability of these tests, an &quot;emergency&quot; authorization was issued for their use in medical laboratories, which then resulted in the urge to verify their reliability and to monitor carefully their performances, in order to avoid the risk to provide inaccurate results. This document illustrates the main potential sources of error, which can be pre-pre-analytical (i.e. test utilization in an incorrect diagnostic window), pre-analytical (i.e. incorrect collection, manipulation, sample transport and storage), analytical (i.e. pipetting errors during manual sample dispensing, incorrect RNA extraction, cDNA synthesis and amplification) and post-analytical (i.e. incorrect test report and interpretation). Furthermore, the key elements for creating a system to keep continuously under control these potential sources of error are presented, both implementing an adequate control of the</p>
Biochimica Clinica ; 45(4) 400-407
Opinioni - Opinions
Information Technology in Medicina di Laboratorio: sviluppo di un'applicazione indipendente per la gestione della tracciabilità e degli esiti dei tamponi per SARS-CoV-2 inviati a strutture esterne
Information Technology in Laboratory Medicine: development of a stand-alone application for the management of the traceability and outcomes of SARS-CoV-2 swabs
<p>Introduction: during the health emergency for SARS-CoV-2 pandemic, the high number of diagnostic swabs from different health care facilities overcome quickly the hospital clinical laboratory capacity of analysis, that was dedicated to in-patients, and first aid department. The processing of this large number of swabs had to be entrusted thus to an external laboratory. As a consequence, the hospital clinical laboratory, under the pressure of an exponentially growing number of samples, allocated internal resources to develop the software described in the paper, for an efficient management of these samples.<br />Methods: an in-house Microsoft Windows Application (Microsoft&reg;) has been written using Visual Basic .NET (Microsoft&reg;) with the support of a relational database provided by Oracle (Oracle&reg;), already deployed in the Hospital Information System. The name of the application is TraceCOVID.<br />Results: the application has an integration with different data entry application and LIS (Laboratory Information System) to receive the information related to the sample. TraceCOVID manages samples&rsquo; check-in and automatically sends and receives data to/from the external laboratory server, associates the report to the specific patient and sends an email message containing the results of the molecular test to each patient. The application offers the possibility to print the report if necessary. There is also a statistics section that monitors the number of samples and the outcomes, generating different types of outputs.<br />Discussion: the health crisis due to COVID19, has highlighted how the presence of informatic skills in the clinical laboratories has made it possible to cope with a critical aspect related to the swabs&rsquo; management, allowing an efficient information flows to the patient and to the health authorities.</p>
Biochimica Clinica ; 45(4) 381-387
Contributi Scientifici - Scientific Papers
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 stima dell'incertezza delle misure nel laboratorio clinico
Measurement uncertainty calculation in clinical laboratories
<p>The result of a measurement is only an estimate of&nbsp;the value of the measurand and it is complete only when accompanied by a statement of the measurement uncertainty.&nbsp;The ISO 15189 standard requires that &ldquo;the laboratory shall determine measurement uncertainty for each measurement&nbsp;procedure&rdquo;. The approach to calculate the measurement uncertainty proposed by the &ldquo;Guide to the expression of&nbsp;uncertainty in measurement&rdquo; (GUM) requires the quantification of every source of variability to sum them up for the&nbsp;final calculation (&ldquo;bottom-up&rdquo; approach). To overcome inherent difficulties in the systematic application of this approach&nbsp;in a clinical laboratory, a &quot;top-down&quot; approach is proposed, through the calculation of measurement uncertainty from&nbsp;already existing data of IQC. The proposed approach is checked by applying it to the IQC data for serum glucose and&nbsp;creatinine measurements collected from 19 clinical laboratories. Different approaches to cope with the issue of the&nbsp;estimate of systematic error (bias) are proposed, based either on value-assigned trueness control/reference materials,&nbsp;on the mean value of the employed material defined by the laboratory at the start of the IQC program or on the peer&nbsp;group mean of an interlaboratory program material. The availability of a standardized way to estimate the measurement&nbsp;uncertainty provides a tool to evaluate the analytical quality of results and it allows comparison of the quality of results&nbsp;made available by different laboratories.</p>
Biochimica Clinica ; 39(2) 108-115
Contributi scientifici - Scientific Papers