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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

Responsible Editor
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 S. Mattioli

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