TY - JOUR TI - Validation of the classification criteria for cryoglobulinaemic vasculitis AU - Quartuccio, Luca AU - Isola, Miriam AU - Corazza, Laura AU - Ramos-Casals, AU - Manuel AU - Retamozo, Soledad AU - Ragab, Gaafar Mohamed AU - Zoheir, AU - Mostafa Naguib AU - El-Menyawi, Manal Abdel-Moneim AU - Salem, Mohamed AU - Nabil AU - Sansonno, Domenico AU - Ferraccioli, Gianfranco AU - Gremese, AU - Elisa AU - Tzioufas, Athanasios AU - Voulgarelis, Michael and AU - Vassilopoulos, Dimitris AU - Scarpato, Salvatore AU - Pipitone, Nicolo and AU - Salvarani, Carlo AU - Guillevin, Loic AU - Terrier, Benjamin AU - Cacoub, AU - Patrice AU - Filippini, Davide AU - Saccardo, Francesco AU - Gabrielli, AU - Armando AU - Fraticelli, Paolo AU - Sebastiani, Marco AU - Tomsic, Matija AU - and Tavoni, Antonio AU - Mazzaro, Cesare AU - Pioltelli, Pietro and AU - Nishimoto, Norihiro AU - Scaini, Patrizia AU - Zignego, Anna Linda and AU - Ferri, Clodoveo AU - Monti, Giuseppe AU - Pietrogrande, Maurizio and AU - Bombardieri, Stefano AU - Galli, Massimo AU - De Vita, Salvatore JO - Rheumatology (Bulgaria) PY - 2014 VL - 53 TODO - 12 SP - 2209-2213 PB - Oxford University Press SN - null TODO - 10.1093/rheumatology/keu271 TODO - cryoglobulinaemia; hepatitis C; classification; vasculitis TODO - Objective. The aim of this study was to validate the classification criteria for cryoglobulinaemic vasculitis (CV). Methods. 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. Results. 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. Conclusion. Classification criteria for CV were validated in a second, large, international study confirming good sensitivity and specificity in a complex systemic disease. ER -