Riassunto
Premesse.
Il Gruppo di Studio in Autoimmunologia della SIMeL ha svolto un’indagine per rilevare le caratteristiche strutturali, le tecnologie impiegate, i volumi di attività diagnostica e gli aspetti di governo clinico dei Laboratori italiani di autoimmunologia nell’anno 2012.
Metodi.
I dati sono stati raccolti utilizzando un questionario distribuito in forma elettronica nel mese di gennaio 2013 a 315 Laboratori di autoimmunologia italiani. Il questionario comprendeva 38 domande relative alle caratteristiche del Laboratorio di autoimmunologia, alle dimensioni del bacino di utenza, al numero di esami di autoimmunologia effettuati, alla fase analitica (strumentazione, test anticorpali e metodi), alla definizione degli intervalli di riferimento. Infine, l’ultima serie di quesiti intendeva esplorare le modalità di refertazione, l’utilizzo di commenti interpretativi e il rapporto con il mondo clinico, sia ospedaliero sia del territorio.
Risultati.
235 (74,6%) Laboratori hanno risposto in tutto o in parte alle domande. I Laboratori che operano nel settore di autoimmunità in Italia sono per l’87% inseriti in ospedali pubblici e per il 13% in strutture private. La metà circa (48%) esegue tra i 10.000 e i 50.000 esami/anno di autoimmunologia e il 30% più di 50.000. Solo il 7% dei Laboratori esegue meno di 5000 esami e questi sono per lo più Laboratori privati. Tra i metodi analitici, l’immunofluorescenza indiretta è utilizzata nel 97% dei Laboratori, i metodi immunoenzimatici sono impiegati nel 96% dei Laboratori e l’immunochemiluminescenza nel 62%. Il 63% dei partecipanti dichiara di inserire un commento interpretativo nel referto. Il 5% utilizza solo commenti codificati, il 9% solo commenti personalizzati e il 49% un commento predefinito o personalizzato a seconda del risultato. In generale, esistono buoni rapporti di collaborazione con i clinici ospedalieri e con i medici di medicina generale e attività di consulenza viene fornita dal 57% dei Laboratori, sia pubblici sia privati.
Conclusioni.
L’elevato numero di risposte ricevute fa ritenere che i dati raccolti e analizzati siano del tutto rappresentativi della realtà organizzativa dei Laboratori italiani e costituiscano un’eccellente fotografia dello stato attuale dell’attività diagnostica autoimmunologica nel nostro Paese.
Summary
Background.
The Study Group on Autoimmune Diseases of the Italian Society of Laboratory Medicine (SIMeL) carried out a national survey to detect structural characteristics, the technologies used, the volume of diagnostic activity and aspects of clinical governance of Italian autoimmunology laboratories in 2012.
Methods.
The data were collected using a questionnaire distributed in electronic form in January 2013 to 315 Italian autoimmunology laboratories. The questionnaire included 38 questions related to the characteristics of the laboratory, the size of the referring area, the number of tests carried out, the analytical phase (instrumentation, antibody tests and methods), the definition of reference intervals. The last series of questions intended to explore ways of reporting, the use of interpretive comments, and the relationship with the clinicians, both hospital specialists and general practioners.
Results.
235 (74.6%) laboratories responded in whole or in part to the questions. The laboratories operating in the field of autoimmunity in Italy are 87% placed in public hospitals and 13% in private facilities. About half (48%) run between 10,000 and 50,000 tests / year, and 30% more than 50,000. Only 7% of the laboratories perform fewer than 5,000 exams and these are mostly private. Among the analytical methods, indirect immunofluorescence is used in 97%, ELISA methods are used in 96% and immunochemiluminescence in 62% of the laboratories. 63% of participants declared to add an interpretive comment in the report: 5% using only canned comments, 9% using only narrative comments, and 49% using predefined or customized comments depending on the result. In general, there are good working relationships with hospitals clinicians and with general practitioners; counseling is provided by 57% of laboratories, both public and private.
Conclusions.
The high number of responses we received suggests that the data collected and analyzed are quite representative of the organizational reality of the Italian laboratories and are an excellent picture of the current state of the autoimmunology diagnostics in our country.
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Bizzaro, N., Tozzoli, R., Morozzi, G. et al. Indagine conoscitiva sull’attività dei Laboratori italiani di autoimmunologia—anno 2012. Riv Ital Med Lab 10, 172–180 (2014). https://doi.org/10.1007/s13631-014-0070-2
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DOI: https://doi.org/10.1007/s13631-014-0070-2