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Maria Stella Graziani

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Martina Zaninotto

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Ferruccio Ceriotti
Davide Giavarina
Bruna Lo Sasso
Giampaolo Merlini
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Rossella Tomaiuolo
Matteo Vidali

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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
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Ana-Maria Simundic Croatia
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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. Frattolillo

Le criticità della fase post-analitica della determinazione delle crioglobuline: risultati di uno studio pilota condotto in Emilia-Romagna
Critical issues of the post-analytical phase for cryoglobulin determination: results of a pilot study carried out in Emilia-Romagna, Italy
<p>Introduction: cryoglobulins (CRG) are immunoglobulins that precipitate at low temperature and dissolve at 37 &deg;C. The difficulties associated to the analisys of cryoproteins, are related to the pre-analytical phase, including the collection of the sample and the maintenance of the heat chain; to the analytical phase, because of the many manual steps involved and, to the post-analytical phase as well, due to the operator-depending interpretation of immunofissation (IFE). The Department of Laboratory Medicine of Modena promoted a pilot study to verify the incidence of the post-analytical phase in the accuracy of the CRG analisys.<br />Methods: 30 images of CRG-IFE plates were selected and sent to 8 centers of the Emilia Romagna region that agreed to join the project; 13 different laboratory professionals have been involved in the IFE interpretation.<br />Results: out of 30 IFE, only 3 (10%) were interpreted with the excellent concordance of 100% by all the participants; 10 of them (33%) showed a good concordance, 75-99%; 14 (47%) sufficient concordance, 50-74%; 3 (10%) a poor concordance &lt;50%. Out of 8 centers involved, 4 participated with more than one operator. Arbitrarily assuming that the analysis can be considered acceptable when at least 75% of the participants agree on the interpretation of the gels, the results show that only in 43% of cases the acceptability was reached.<br />Discussion: this pilot study highlights the need to harmonize the CRG determination, not only the pre-analytical and analytical procedures, but also the post-analytical phase. To this end, it could be highly recommended that the clinical laboratories participate to external quality assessment control programs, as the one promoted by UK-NEQAS. Moreover, scientific societies and their Study Groups, can play an important role by promoting the harmonization of CGR evaluation.</p>
Biochimica Clinica ; 45(4) 388-394
Contributi Scientifici - Scientific Papers
Valutazione di un sistema esperto per la validazione di tracciati elettroforetici delle proteine del siero
Evaluation of an expert system for computer-supported evaluation of serum protein electrophoresis patterns
<p>Serum proteins electrophoresis (SPE) is mainly ordered for screening and follow-up of monoclonal gammopathies (MG). Several softwares have been developed to assist the process, but none has been able to replace human validation. In this paper we describe the performance of an expert system (ES), integrated by Sebia into Phoresis software, for validation of negative SPE patterns obtained on Capillarys 2, combining qualitative analysis of SPE patterns by neural networks with a semi-quantitative evaluation of SPE fractions and providing classification in real time. 10,055 patterns, evaluated by supervisor scientists without knowing ES classification, subsequently underwent ES analysis. Sensitivity, specificity and predictive values (PV) of ES classification were calculated. Agreement with human operator for classifying patterns was calculated by Cohen&rsquo;s kappa, obtaining a value of 0.31 indicating fair agreement. Sensitivity and specificity of software alerts for MG detection were 100% and 49.3%, respectively, with 23.7% positive PV and 100% negative PV. Sensitivity and negative PV for a<sub>1</sub>-antitrypsin deficit and hypogammaglobulinemia were 100%. The combination of morphologic analysis by neural networks and quantitative assessment of every SPE fraction allowed a very good performance in detection of SPE patterns that did not display abnormalities. In conclusion, the evaluated ES is a safe and efficient method for validating normal SPE patterns, allowing ~40% time saving and a better standardization of inter-observer evaluations.</p>
Biochimica Clinica ; 40(4) 316-321
Contributi scientifici - Scientific Papers
Accuratezza diagnostica di un’immunofissazione urinaria semplificata per la ricerca e tipizzazione della proteina di Bence Jones
Diagnostic accuracy of a simplified urine immunofixation for the Bence Jones (BJ) protein detection and typing
<p>We assessed the diagnostic accuracy of a modified routinely used commercial kit to screen for BJ. The study&nbsp;consisted in the revision of 1077 urine immunofixation that included antisera against free light chains (full IF),&nbsp;performed with Sebia Hydragel 2/4 BJ kit according to the manufacturer&rsquo;s instructions. Two experts reassessed all&nbsp;gels, comparing the results of the full IF against those obtained excluding the lanes treated with the anti-free light&nbsp;chain antisera (simplified IF). 886 samples were negative and 123 samples were positive with both tests. One false&nbsp;negative sample was observed by the simplified IF, while 67 samples could not be interpreted using this type of IF.&nbsp;Sensitivity and specificity of the simplified IF were 99.3% and 94.8% respectively. On the basis of the obtained results,&nbsp;the following algorithm to screen for BJ can be suggested: simplified IF as first step followed by a full IF only in case&nbsp;of inconclusive results (e.g. in presence of monoclonal bands reacting both with heavy and total light chain antisera&nbsp;or elevated concentrations of polyclonal immunoglobulins). By using the simplified IF alone, 86.6% of positive&nbsp;samples would have been typed correctly without the need of a full IF.</p>
Biochimica Clinica ; 39(4) 264-269
Contributi scientifici - Scientific Papers