Riassunto
Il Gruppo di Studio in Autoimmunologia (GdS-AI) della Società Italiana di Patologia Clinica e Medicina di Laboratorio (SIPMeL), dopo 14 anni dalla ultima edizione, ha ritenuto opportuno revisionare e integrare le “linee guida per l’impiego di test per autoanticorpi nucleo-citoplasmatici nella diagnosi e nel monitoraggio delle malattie autoimmuni sistemiche”, con l’aggiunta di nuove tematiche, la modifica di precedenti raccomandazioni e la rivalutazione di aspetti controversi del precedente documento.
Per l’elaborazione di questa edizione, la valutazione della “qualità delle evidenze” e l’espressione della “forza delle raccomandazioni” sono state definite secondo il metodo GRADE (Grading of Recommendation Assessment, Development and Evaluation), frutto dell’attività avviata nel 2000 da un gruppo di lavoro internazionale che aveva come scopo la definizione di un metodo rigoroso ed esplicito per la produzione di raccomandazioni cliniche. Il documento è articolato in 18 raccomandazioni, suddivise in 4 sezioni; ognuna di esse è introdotta da un quesito clinico con scelta e valutazione formale degli outcome a esso correlati, seguito dalla valutazione sistematica della letteratura scientifica e della qualità delle prove reperite. La definizione formale della forza delle raccomandazioni, espressa come “forte” o “debole”, è stata assegnata per consenso da tutti i membri del GdS-AI della SIPMeL. Questa revisione delle linee guida, nel fornire una sintesi sullo stato attuale dei test per la ricerca degli autoanticorpi anti-antigeni intracellulari, formula una serie di raccomandazioni rivolte soprattutto all’appropriatezza della richiesta, alla metodologia analitica da utilizzare, all’interpretazione e alla modalità di refertazione dei risultati. Infine, il documento affronta problematiche ancora aperte, quali l’utilizzo di nuovi termini e acronimi per denominare i test autoanticorpali in uso nella diagnostica delle malattie reumatiche autoimmuni e la standardizzazione dei metodi di dosaggio degli autoanticorpi.
Summary
After 14 years since the last edition, the Study Group on Autoimmune Diseases (GdS-AI) of the Italian Society of Clinical Pathology and Laboratory Medicine (SIPMeL) has revised and supplemented the “Guidelines for the laboratory use of autoantibody tests in the diagnosis and monitoring of autoimmune rheumatic diseases”, with addition of new themes, update of recommendations and revaluation of the controversial aspects of the previous document. For the preparation of this edition, the assessment of the “quality of evidence” and of “strength of the recommendations” has been defined by the GRADE (Grading of Recommendation Assessment, Development and Evaluation) method, developed in 2000 by an international working group as a rigorous and explicit method for the production of clinical recommendations. The document is divided into 4 sections including 18 recommendations; each is introduced by a question, followed by the systematic evaluation of the scientific literature and the quality of the evidence found. The formal definition of the strength of the recommendations, expressed as “strong” or “weak”, has been assigned by consensus of all members of GdS-AI SIPMeL. This updated revision of the guidelines provides an overview on the current status of the tests for the detection of autoantibodies to intracellular antigens, including solid phase immunoassays and the automated reading of indirect immunofluorescence. Recommendations are directed mainly to the appropriateness of the request, the analytical methodology to be used, the interpretation and reporting of results. Finally, the document approaches open issues, such as the use of new terms and acronyms to name autoantibody tests used to diagnose autoimmune rheumatic diseases and the harmonization of procedures for the detection of autoantibodies.
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Per il Gruppo di Studio in Autoimmunologia della Società Italiana di Patologia Clinica e Medicina di Laboratorio
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Hanno collaborato alla realizzazione di questo documento, partecipando alla consensus conference tenutasi a Padova nei giorni 13 e 14 febbraio 2015, i seguenti componenti del Gruppo di Studio in Autoimmunologia della Società Italiana di Patologia Clinica e Medicina di Laboratorio:
Gaetano Amato, UO Patologia Clinica, PO Civico e Benfratelli, ARNAS, Palermo, Italia; Giuseppina Barberio, Medicina di Laboratorio, Dipartimento di Patologia Clinica, ULSS 9, Treviso, Italia; Ignazio Brusca, Laboratorio Analisi, Ospedale Buccheri La Ferla, Palermo, Italia; Massimo Daves e Stefan Platzgummer, Laboratorio Centrale, Ospedale “Franz Tappeiner”, Merano, Italia; Martina Fabris, Istituto di Patologia Clinica, Azienda Ospedaliero-Universitaria, Udine, Italia; Elia Girolami, Laboratorio di Autoimmunità, Dipartimento di Oncoematologia Pediatrica e Medicina Trasfusionale, Ospedale Pediatrico Bambino Gesù, Roma, Italia; Tiziana Imbastaro, UOS Diagnostica di Laboratorio delle Malattie Autoimmuni, PO Spirito Santo, Pescara, Italia; Maria Infantino, Laboratorio di Immunologia e Allergologia, Ospedale S. Giovanni di Dio, Firenze, Italia; Maura Musso, Laboratorio Analisi, Azienda Ospedaliera S. Croce, Cuneo, Italia; Maria Concetta Sorrentino, Laboratorio Analisi Chimico Cliniche e Microbiologiche, ISMETT, Palermo, Italia.
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Cinquanta, L., Bizzaro, N., Villalta, D. et al. Linee guida per l’utilizzo dei test autoanticorpali nella diagnosi e nel monitoraggio delle malattie autoimmuni reumatiche sistemiche. Revisione 2015. Riv Ital Med Lab 11, 205–224 (2015). https://doi.org/10.1007/s13631-015-0099-x
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DOI: https://doi.org/10.1007/s13631-015-0099-x