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Rheumatology (Oxford). 2014 Dec;53(12):2209-13. doi: 10.1093/rheumatology/keu271. Epub 2014 Jul 3.

Validation of the classification criteria for cryoglobulinaemic vasculitis.

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Rheumatology Clinic, Department of Medical and Biological Sciences, Azienda Ospedaliero Universitaria S. Maria della Misericordia, Department of Medical and Biological Sciences, Institute of Statistics, University of Udine, Udine, Italy, Laboratorio de Enfermedades Autoinmunes Josep Font, IDIBAPS, Hospital Clínic, Barcelona, Spain, Faculty of Medicine, Cairo University, Cairo, Faculty of Medicine, BeniSwafe University, BeniSwafe, Egypt, Section of Internal Medicine and Clinical Oncology, Department of Biomedical Sciences and Human Oncology, University of Bari Medical School, Bari, Rheumatology Division, Catholic University of the Sacred Heart, Rome, Italy, Department of Pathophysiology, Medical School of Athens, Second Department of Medicine, Hippokration General Hospital, Athens, Greece, Rheumatology Unit, M. Scarlato Hospital, Scafati, Salerno, Division of Rheumatology, Arcispedale S. Maria Nuova, Reggio Emilia, Italy, Centre de Références Maladies Auto-Immunes, Service de Médecine Interne II, Hôpital Pitié-Salpêtrière, Service de Médecine Interne, Hôpital Cochin, Paris, France, Rheumatology Unit, Niguarda Ca' Granda Hospital, Milan, Internal Medicine Unit, Saronno Hospital, Azienda Ospedaliera di Busto Arsizio, Saronno, Internal Medicine, Università Politecnica delle Marche, Ancona, Rheumatology Unit, Department of Internal Medicine, University of Modena, Modena, Italy, Department of Rheumatology, University Medical Centre, Ljubljana, Slovenia, Rheumatology Unit, Department of Internal Medicine, University of Pisa, Pisa, Department of Internal Medicine, Pordenone General Hospital, Pordenone, Internal Medicine, Donizetti Hospital, Monza, Italy, Osaka Rheumatology Clinic and Department of Molecular Regulation for Intractable Diseases, Institute of Medical Science, Tokyo Medical University, Japan, Nephrology Department, A.O. Spedali Civili, Brescia, Center for Systemic Manifestations of Hepatitis Viruses (MaSVE), Department of Internal Medicine, Universit



The aim of this study was to validate the classification criteria for cryoglobulinaemic vasculitis (CV).


Twenty-three centres were involved. New patients with CV (group A) and controls, i.e. subjects with serum cryoglobulins but lacking CV based on the gold standard of clinical judgment (group B) and subjects without cryoglobulins but with clinical features that can be observed in the course of CV (group C), were studied. Positivity of serum cryoglobulins was necessary for CV classification. Sensitivity and specificity of the criteria were calculated by comparing group A vs group B. The group A vs group C comparison was done to demonstrate the possible diagnostic utility of the criteria.


The study included 268 patients in group A, 182 controls in group B and 193 controls in group C (small vessel vasculitis, 51.8%). The questionnaire (at least 2/3 positive answers) showed 89.0% sensitivity and 93.4% specificity; the clinical item (at least 3/4 clinical involvement) showed 75.7% sensitivity and 89.0% specificity and the laboratory item (at least 2/3 laboratory data) showed 80.2% sensitivity and 62.4% specificity. The sensitivity and specificity of the classification criteria (at least 2/3 positive items) were 89.9% and 93.5%, respectively. The comparison of group A with group C demonstrated the clinical utility of the criteria in differentiating CV from CV mimickers.


Classification criteria for CV were validated in a second, large, international study confirming good sensitivity and specificity in a complex systemic disease.


classification; cryoglobulinaemia; hepatitis C; vasculitis

[Indexed for MEDLINE]

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