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Quanto e come vengono applicate le linee guida in Autoimmunologia nei Laboratori italiani?

Do Autoimmunology Laboratories follow guidelines? An Italian survey

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La Rivista Italiana della Medicina di Laboratorio - Italian Journal of Laboratory Medicine

Riassunto

Il Gruppo di Studio in Autoimmunologia della Società Italiana di Patologia Clinica e Medicina di Laboratorio in un meeting tenutosi a Mondello (Palermo) nell’ottobre 2015 ha affrontato il tema dell’applicazione delle linee guida internazionali nella diagnostica delle malattie autoimmuni nei Laboratori italiani. Riportiamo qui i risultati di un sondaggio effettuato durante il convegno nel quale i partecipanti, attraverso il televoto in aula, hanno espresso il grado di applicazione nei loro Laboratori ed evidenziato gli aspetti critici relativi a quattro linee guida sulla diagnostica di Laboratorio della malattia celiaca, delle malattie reumatiche autoimmuni, delle sindromi da anticorpi anti-fosfolipidi e delle vasculiti ANCA-associate. I risultati dimostrano che nei Laboratori Italiani di Autoimmunologia c’è grande attenzione nei confronti di questa articolata e complessa specialità e che c’è la consapevolezza che le linee guida basate sulle prove scientifiche costituiscono un modello adeguato per perseguire finalità di appropriatezza e accuratezza diagnostica.

Summary

The Study Group on Autoimmune Diseases of the Italian Society of Clinical Pathology and Laboratory Medicine in a meeting held in Mondello (Palermo) in October 2015 dealt with the issue of the application of international guidelines on the diagnosis of autoimmune diseases in Italian laboratories. Here we report the results of a survey conducted during the conference in which the participants through the televoting, have expressed the degree of compliance and highlighted critical aspects related to four guidelines on the diagnosis of celiac disease, autoimmune rheumatic diseases, anti-phospholipid syndrome and ANCA-associated vasculitis. The results show that in Italian Autoimmunology Laboratories there is great attention to this detailed and complex diagnostic specialty and that there is awareness that the evidence-based guidelines are an adequate model to pursue appropriateness and diagnostic accuracy purposes.

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Bibliografia

  1. Bizzaro N, Tozzoli R, Morozzi G et al. (2014) Indagine conoscitiva sull’attività dei Laboratori italiani di autoimmunologia—anno 2012. Riv Ital Med Lab 10:172–180

    Article  Google Scholar 

  2. Husby S, Koletzko S, Korponay-Szabó IR et al. (2012) European society for pediatric gastroenterology, hepatology and nutrition guidelines for the diagnosis of coeliac disease. J Pediatr Gastroenterol Nutr 54:136–160

    Article  CAS  PubMed  Google Scholar 

  3. Rubio-Tapia A, Hill ID, Kelly CP et al. (2013) ACG clinical guidelines: diagnosis and management of celiac disease. Am J Gastroenterol 108:656–676

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  4. Gazzetta Ufficiale della Repubblica Italiana, Serie generale 19–8–2015, p 147, http://www.celiachia.it/public/bo/upload/aic%5Cdoc/GU%20191%202015.pdf (Accesso 15 settembre 2016)

  5. Porcelli B, Alessio MG, Villalta D et al. (2015) Linee guida per la diagnosi di laboratorio e istologica della malattia celiaca. Revisione 2015. Riv Ital Med Lab 11:76–95

    Article  Google Scholar 

  6. Sugai E, Vazquez H, Nachman F et al. (2006) Accuracy of testing for antibodies to synthetic gliadin-peptides in celiac disease. Clin Gastroenterol Hepatol 4:1112–1117

    Article  CAS  PubMed  Google Scholar 

  7. Volta U, Granito A, Fiorni E et al. (2008) Usefulness of antibodies to deaminated gliadin peptides in celiac disease diagnosis and follow up. Dig Dis Sci 53:1582–1588

    Article  CAS  PubMed  Google Scholar 

  8. Liu E, Li M, Emery L et al. (2007) Natural history of antibodies to deaminated gliadin peptides and transglutaminase in early childhood celiac disease. J Pediatr Gastroenterol Nutr 45:293–300

    Article  CAS  PubMed  Google Scholar 

  9. Lewis NR, Scott BB (2010) Meta-analysis: deamidated gliadin peptide antibody and tissue transglutaminase antibody compared as screening tests for coeliac disease. Aliment Pharmacol Ther 31:73–81

    Article  CAS  PubMed  Google Scholar 

  10. Giersiepen K, Lelgemann M, Stuhldreher N et al. (2012) Accuracy of diagnostic antibody tests for coeliac disease in children: summary of an evidence report. J Pediatr Gastroenterol Nutr 54:229–241

    Article  CAS  PubMed  Google Scholar 

  11. Brusca I, Carroccio A, Tonutti E et al. (2011) The old and new tests for celiac disease: which is the best test combination to diagnose celiac disease in pediatric patients? Clin Chem Lab Med 50:111–117

    PubMed  Google Scholar 

  12. Catassi C, Fasano A (2010) Celiac disease diagnosis: simple rules are better than complicated algorithms. Am J Med 123:691–693

    Article  PubMed  Google Scholar 

  13. Meroni PL, Schur PH (2010) ANA screening: an old test with new recommendations. Ann Rheum Dis 69:1420–1422

    Article  CAS  PubMed  Google Scholar 

  14. Shoenfeld Y, Cervera R, Gershwin ME (2008) Diagnostic criteria in autoimmune diseases. Humana Press, Totowa

    Book  Google Scholar 

  15. Mahler M, Miller FW, Fritzler MJ (2014) Idiopathic inflammatory myopathies and the anti-synthetase syndrome: a comprehensive review. Autoimmun Rev 13:367–371

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  16. Stinton LM, Fritzler MJ (2007) A clinical approach to autoantibody testing in systemic autoimmune rheumatic disorders. Autoimmun Rev 7:77–84

    Article  CAS  PubMed  Google Scholar 

  17. Mahler M, Meroni PL, Bossuyt X et al. (2014) Current concepts and future directions for the assesment of autoantibodies to cellular antigens referred to as anti-nuclear antibodies. J Immunol Res 2014:315179

    PubMed  PubMed Central  Google Scholar 

  18. Burlingame R, Peebles C (2006) Detection of antibodies. In: Pollard KM (ed) Autoantibodies and autoimmunity: molecular mechanisms in health and disease. Wiley–VCH, Weinheim, pp 159–188

    Google Scholar 

  19. Holman H, Robbins W (1959) Antinuclear antibodies in systemic lupus erythematosus. Arthritis Rheum 2:468–471

    Article  CAS  PubMed  Google Scholar 

  20. Cinquanta L, Bizzaro N, Villalta D et al. (2015) 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

    Article  Google Scholar 

  21. Bizzaro N, Wiik A (2004) Appropriateness in anti-nuclear antibody testing: from clinical request to strategic laboratory practice. Clin Exp Rheumatol 22:349–355

    CAS  PubMed  Google Scholar 

  22. Homburger HA (1995) Cascade testing for autoantibodies in connective tissue diseases. Mayo Clin Proc 70:183–184

    Article  CAS  PubMed  Google Scholar 

  23. Tonutti E, Bizzaro N, Morozzi G et al. (2015) Il test ANA-reflex. Riv Ital Med Lab 11:171–175

    Article  Google Scholar 

  24. Srivastava R, Bartlett WA, Kennedy IM et al. (2010) Reflex and reflective testing: efficiency and effectiveness of adding on laboratory tests. Ann Clin Biochem 47:223–227

    Article  CAS  PubMed  Google Scholar 

  25. Bizzaro N, Morozzi G (2009) A proposed model for effective collaboration between rheumatologists and clinical pathologists for the diagnosis of autoimmune rheumatic diseases. Rheumatol Int 29:849–851

    Article  PubMed  Google Scholar 

  26. Tozzoli R, Bizzaro N (2012) The clinical autoimmunologist and the laboratory autoimmunologist: the two sides of the coin. Autoimmun Rev 11:766–770

    Article  PubMed  Google Scholar 

  27. Tampoia M, Brescia V, Fontana A et al. (2007) Application of a combined protocol for rational request and utilization of antibody assays improves clinical diagnostic efficacy in autoimmune rheumatic disease. Arch Pathol Lab Med 131:112–116

    CAS  PubMed  Google Scholar 

  28. Bonaguri C, Melegari A, Ballabio A et al. (2011) Italian multicentre study for application of a diagnostic algorithm in autoantibody testing for autoimmune rheumatic disease: conclusive results. Autoimmun Rev 11:1–5

    Article  PubMed  Google Scholar 

  29. Savige J, Gillis D, Benson E et al. (1999) International consensus statement on testing and reporting of antineutrophil cytoplasmatic antibodies (ANCA). Am J Clin Pathol 111:507–513

    Article  CAS  PubMed  Google Scholar 

  30. Savige J, Dimech W, Fritzler M et al. (2003) Addendum to the international consensus statement on testing and reporting of antineutrophil cytoplasmic antibodies. Quality control guidelines, comments, and recommendations for testing in other autoimmune diseases. Am J Clin Pathol 120:312–318

    Article  CAS  PubMed  Google Scholar 

  31. Sinico RA, Radice A (2014) Antineutrophil cytoplasmic antibodies (ANCA) testing: detection method and clinical application. Clin Exp Rheumatol 32(Suppl 82):S112–S117

    PubMed  Google Scholar 

  32. Vermeersch P, Vervaeke S, Blockmans D et al. (2008) Determination of anti-neutrophil cytoplasmic antibodies in small vessel vasculitis: comparative analysis of different strategies. Clin Chim Acta 397:77–81

    Article  CAS  PubMed  Google Scholar 

  33. Rao DA, Wei K, Merola JF et al. (2015) Myeloperoxidase-antineutrophil cytoplasmic antibodies (MPO-ANCA) and proteinase 3-ANCA without immunofluorescent ANCA found by routine clinical testing. J Rheumatol 42:847–852

    Article  CAS  PubMed  Google Scholar 

  34. Oudkerk Pool M, Ellerbroek PM, Ridwan BU et al. (1993) Serum antineutrophil cytoplasmic autoantibodies in inflammatory bowel disease are mainly associated with ulcerative colitis. A correlation study between perinuclear antineutrophil cytoplasmic autoantibodies and clinical parameters, medical, and surgical treatment. Gut 34:46–50

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  35. Lecis P, Germanà B, Papa N et al. (2002) p-ANCA and ASCA antibodies in the differential diagnosis between ulcerative rectocolitis and Crohn’s disease. Recenti Prog Med 93:308–313

    PubMed  Google Scholar 

  36. Wilson WA, Gharavi AE, Koike T et al. (1999) International consensus statement on preliminary classification criteria for definite antiphospholipid syndrome: report of an international workshop. Arthritis Rheum 42:1309–1311

    Article  CAS  PubMed  Google Scholar 

  37. Miyakis S, Lockshin MD, Atsumi T et al. (2006) International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost 4:295–306

    Article  CAS  PubMed  Google Scholar 

  38. Lakos G, Favaloro EJ, Harris EN et al. (2012) International consensus guidelines on anticardiolipin and anti-\(\upbeta\)2 glycoprotein I testing: report from the 13th International Congress on Antiphospholipid Antibodies. Arthritis Rheum 64:1–10

    Article  PubMed  Google Scholar 

  39. Galli M, Luciani D, Bertolini G et al. (2003) Lupus anticoagulants are stronger risk factors of thrombosis than anticardiolipin antibodies in the antiphospholipid syndrome: a systematic review of the literature. Blood 101:1827–1832

    Article  CAS  PubMed  Google Scholar 

  40. Pengo V, Banzato A, Bison E et al. (2012) What have we learned about antiphospholipid syndrome from patients and antiphospholipid carrier cohorts? Semin Thromb Hemost 38:322–327

    Article  CAS  PubMed  Google Scholar 

  41. Tincani A, Allegri F, Sanmarco M et al. (2001) Anticardiolipin antibody assay: a methodological analysis for a better consensus in routine determinations a cooperative project of the European Antiphospholipid forum. Thromb Haemost 86:575–583

    CAS  PubMed  Google Scholar 

  42. Wong RC, Gillis D, Adelstein S et al. (2004) Consensus guidelines on anti-cardiolipin antibody testing and reporting. Pathology 36:63–68

    Article  CAS  PubMed  Google Scholar 

  43. Cervera R, Conti F, Doria A et al. (2012) Does seronegative antiphospholipid syndrome really exist? Autoimmun Rev 11:581–584

    Article  CAS  PubMed  Google Scholar 

  44. Nayfe R, Uthman I, Aoun J et al. (2013) Seronegative antiphospholipid syndrome. Rheumatology (Oxf) 52:1358–1367

    Article  Google Scholar 

  45. Sorice M, Griggi T, Circella A et al. (1994) Detection of antiphospholipid antibodies by immunostaining on thin layer chromatography plates. J Immunol Methods 173:49–54

    Article  CAS  PubMed  Google Scholar 

  46. Conti F, Alessandri C, Sorice M et al. (2012) Thin-layer chromatography immunostaining in detecting anti-phospholipid antibodies in seronegative anti-phospholipid syndrome. Clin Exp Immunol 167:429–437

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  47. Conti F, Capozzi A, Truglia S et al. (2014) The mosaic of ‘seronegative’ antiphospholipid syndrome. J Immunol Res 2014:389601

    Article  PubMed  PubMed Central  Google Scholar 

  48. Tincani A, Spatola L, Prati E et al. (1996) The anti-beta2-glycoprotein I activity in human anti-phospholipid syndrome sera is due to monoreactive low-affinityautoantibodies directed to epitopes located on native beta2-glycoprotein I and preserved during species’ evolution. J Immunol 157:5732–5738

    CAS  PubMed  Google Scholar 

  49. Bouma B, de Groot PG, van den Elsen JM et al. (1999) Adhesion mechanism of human beta(2)-glycoprotein I to phospholipids based on its crystal structure. EMBO J 18:5166–5174

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  50. De Groot PG, Meijers JC (2011) \(\upbeta\)(2)-glycoprotein I: evolution, structure and function. J Thromb Haemost 9:1275–1284

    Article  PubMed  Google Scholar 

  51. Meroni PL (2016) Anti-beta-2 glycoprotein I epitope specificity: from experimental models to diagnostic tools. Lupus 25:905–910

    Article  CAS  PubMed  Google Scholar 

  52. Chighizola CB, Gerosa M, Meroni PL (2014) New tests to detect antiphospholipid antibodies: anti-domain I beta-2-glycoprotein-I antibodies. Curr Rheumatol Rep 16:402

    Article  PubMed  Google Scholar 

  53. Zhang S, Wu Z, Chen S et al. (2016) Evaluation of the diagnostic potential of antibodies to beta2-glycoprotein 1 domain 1 in Chinese patients with antiphospholipid syndrome. Sci Rep 6:23839

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  54. Pericleous C, Ferreira I, Borghi O et al. (2016) Measuring IgA anti-\(\upbeta\)2-glycoprotein I and IgG/IgA anti-domain I antibodies adds value to current serological assays for the antiphospholipid syndrome. PLoS ONE 11:e0156407

    Article  PubMed  PubMed Central  Google Scholar 

  55. Atsumi T, Ieko M, Bertolaccini ML et al. (2000) Association of autoantibodies against the phosphatidylserine–prothrombin complex with manifestations of the antiphospholipid syndrome and with the presence of lupus anticoagulant. Arthritis Rheum 43:1982–1993

    Article  CAS  PubMed  Google Scholar 

  56. Sciascia S, Sanna G, Murru V et al. (2014) Anti-prothrombin (aPT) and antiphosphatidylserine/prothrombin (aPS/PT) antibodies and the risk of thrombosis in the antiphospholipid syndrome. A systematic review. Thromb Haemost 111:354–364

    Article  CAS  PubMed  Google Scholar 

  57. Branch DW, Khamashta MA (2003) Antiphospholipid syndrome: obstetric diagnosis, management, and controversies. Obstet Gynecol 101:1333–1344

    PubMed  Google Scholar 

  58. Ortona E, Capozzi A, Colasanti T et al. (2010) Vimentin/cardiolipin complex as a new antigenic target of the antiphospholipid syndrome. Blood 116:2960–2967

    Article  CAS  PubMed  Google Scholar 

  59. Murthy V, Willis R, Romay-Penabad Z et al. (2013) Value of isolated IgA anti-\(\upbeta\)2-glycoprotein I positivity in the diagnosis of the antiphospholipid syndrome. Arthritis Rheum 65:3186–3193

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  60. CLSI (2014) Laboratory testing for the lupus anticoagulant; Approved Guideline, CLSI document H60-A. Wayne, PA, USA: CLSI

  61. Favaloro EJ, Wong RC (2014) Antiphospholipid antibody testing for the antiphospholipid syndrome: a comprehensive pratical review including a synopsis of challenges and recent guidelines. Pathology 46:481–495

    Article  CAS  PubMed  Google Scholar 

  62. De Moerloose P, Reber G, Musial J et al. (2010) Analytical and clinical performance of a new, automated assay panel for the diagnosis of antiphospholipid syndrome. J Thromb Haemost 8:1540–1546

    Article  Google Scholar 

  63. Meneghel L, Ruffatti A, Gavasso S et al. (2015) The clinical performance of a chemiluminescent immunoassay in detecting anti-cardiolipin and anti-\(\upbeta\)2 glycoprotein I antibodies. A comparison with a homemade ELISA method. Clin Chem Lab Med 53:1083–1089

    Article  CAS  PubMed  Google Scholar 

  64. Tozzoli R, Bonaguri C, Melegari A et al. (2013) Current state of diagnostic technologies in the autoimmunology laboratory. Clin Chem Lab Med 51:129–138

    Article  CAS  PubMed  Google Scholar 

  65. Bizzaro N, Tozzoli R, Villalta D (2015) Autoimmune diagnostics: the technology, the strategy and the clinical governance. Immunol Res 61:126–134

    Article  CAS  PubMed  Google Scholar 

  66. Pengo V, Biasiolo A, Pegoraro C et al. (2005) Antibody profiles for the diagnosis of antiphospholipid syndrome. Thromb Haemost 93:1147–1152

    CAS  PubMed  Google Scholar 

  67. Ruffatti A, Tonello M, Del Ross T et al. (2006) Antibody profile and clinical course in primary antiphospholipid syndrome with pregnancy morbidity. Thromb Haemost 96:337–341

    CAS  PubMed  Google Scholar 

  68. Lee EY, Lee CK, Lee TH et al. (2003) Does the anti-\(\upbeta\)2-glycoprotein I antibody provide additional information in patients with thrombosis? Thromb Res 111:29–32

    Article  CAS  PubMed  Google Scholar 

  69. Male C, Foulon D, Hoogendoorn H et al. (2005) Predictive values of persistent versus transient antiphospholipid antibody subtypes for the risk of thrombotic events in pediatric patients with systemic lupus erythematosus. Blood 106:4152–4158

    Article  CAS  PubMed  Google Scholar 

  70. Forastiero R, Martinuzzo M, Pombo G et al. (2005) A prospective study of antibodies to beta2-glycoprotein I and prothrombin and risk of thrombosis. J Thromb Haemost 3:1231–1238

    Article  CAS  PubMed  Google Scholar 

  71. Galli M (2010) The antiphospholipid triangle. J Thromb Haemost 8:234–236

    Article  CAS  PubMed  Google Scholar 

  72. Otomo K, Atsumi T, Amengual O et al. (2012) Efficacy of the antiphospholipid score for the diagnosis of antiphospholipid syndrome and its predictive value for thrombotic events. Arthritis Rheum 64:504–512

    Article  CAS  PubMed  Google Scholar 

  73. Sciascia S, Bertolaccini ML, Roccatello D et al. (2013) Independent validation of the antiphospholipid score for the diagnosis of antiphospholipid syndrome. Ann Rheum Dis 72:142–143

    Article  PubMed  Google Scholar 

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Authors and Affiliations

  1. Dipartimento Biotecnologie Mediche, Università degli Studi di Siena, Laboratorio di Patologia Clinica, AOU Senese, Siena, Italia

    Brunetta Porcelli

  2. Laboratorio di Patologia Clinica, Azienda Ospedaliera San Giovanni di Dio e Ruggi D’Aragona, Salerno, Italia

    Luigi Cinquanta

  3. Medicina di Laboratorio, Dipartimento di Patologia Clinica, Unità Locale Socio Sanitaria 9, Treviso, Italia

    Giuseppina Barberio

  4. Dipartimento di Medicina di Laboratorio e Biotecnologie avanzate, Laboratorio di Patologia Clinica, Microbiologia e Virologia, ISMETT, Palermo, Italia

    Maria Concetta Sorrentino

  5. UOC di Patologia Clinica, Ospedale Buccheri La Ferla FBF, Palermo, Italia

    Ignazio Brusca

  6. Laboratorio di Patologia Clinica, Ospedale San Antonio, Tolmezzo, UD, Italia

    Nicola Bizzaro

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  1. Brunetta Porcelli
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  2. Luigi Cinquanta
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  3. Giuseppina Barberio
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  4. Maria Concetta Sorrentino
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  5. Ignazio Brusca
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  6. Nicola Bizzaro
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Correspondence to Nicola Bizzaro.

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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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Porcelli, B., Cinquanta, L., Barberio, G. et al. Quanto e come vengono applicate le linee guida in Autoimmunologia nei Laboratori italiani?. Riv Ital Med Lab 12, 221–233 (2016). https://doi.org/10.1007/s13631-016-0134-6

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