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Maria Stella Graziani

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Giampaolo Merlini
Martina Montagnana
Andrea Mosca
Paola Pezzati
Rossella Tomaiuolo
Matteo Vidali

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BC: Articoli scritti da M. Vidali

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
 
Protocollo per la comparazione di due metodi analitici di laboratorio
Protocol for the comparison of two laboratory methods
<p>Method comparison is one of the main concerns in&nbsp;Laboratory Medicine. With the introduction of new methods with potential advantages (e.g., cost reduction, improvement&nbsp;in efficiency, easier procedures and maintenance) the laboratory staff should investigate if the field method in use may&nbsp;be replaced by the new candidate method without compromising analytical quality nor resulting in a different medical&nbsp;decision or patient management. Several statistical approaches and graphical tools are available to investigate sources&nbsp;of analytical error and for decision-making. In this article, we present an operative protocol for the comparison of two&nbsp;quantitative analytical methods. All sequential steps, including experimental design, familiarization with the new method,&nbsp;quality assessment, sample selection, definition of acceptability criteria, sample measurement, data analysis and&nbsp;evaluation, final decision and reporting, are discussed and exemplified.</p>
Biochimica Clinica ; 40(2) 129-142
Documenti SIBioC - SIBioC Documents
 
Stato dell’arte delle analisi farmacotossicologiche nei laboratori di tossicologia italiani
State of the art of pharmacotoxicological analyses in Italian toxicology laboratories
<p>Analyses for drug and&nbsp;substance abuse represent a considerable part of the daily workload of pharmacotoxicology laboratories (PL).&nbsp;Lacking specific rules, PL have developed their own analytical drug testing procedures and, in turn, personalized&nbsp;reports and interpretation. In 2013, the SIBioC Toxicology Study Group did a national survey to assess the situation&nbsp;of the Italian PL involved in drug testing. Here data from this survey are reported. The survey included two&nbsp;questionnaires aimed to clarify laboratory procedures used for workplace drug and drug and alcohol on the road,&nbsp;respectively. The variability of qualitative variables was evaluated by the Gini index of heterogeneity. Although a low&nbsp;response rate to the survey (&lt;30 respondents), data clearly showed a high heterogeneity of laboratory procedures,&nbsp;including preanalytical (custody chain, methods of sample collection, sample volumes, sample adulteration check),&nbsp;analytical (instrumentations, methods, cut-offs) and post-analytical aspects (qualitative or quantitative reporting), in&nbsp;some cases even different from procedures required by Italian law, when available. To avoid subjective interpretation,&nbsp;which could lead to different treatments of citizens, an harmonization of analytical procedures used by the Italian PL&nbsp;is mandatory.</p>
Biochimica Clinica ; 39(2) 100-107
Contributi scientifici - Scientific Papers
 
Rispondono gli Autori dell'articolo in questione
In reply
M. Vidali  |  G. Bellomo  | 
Biochimica Clinica ; 35(2) 158
LETTERE ALL'EDITORE - Letters to the Editor