Diagnostic evaluation and classification criteria in Sjögren's Syndrome.

Abstract Objectives Our objective is to carry out a clinical study of the performance of the preliminary European classification criteria for Sjogren Syndrome and that of the criteria proposed by the American European Consensus Group. Methods Eighty-eight patients who had undergone a biopsy of the salivary gland on suspicion that they were suffering from Sjogren Syndrome were studied by two independent rheumatologists. Two pathologists independently revised the biopsies without knowing the diagnosis. With all of this information, the clinicians established, or did not establish, a diagnosis of primary Sjogren Syndrome or secondary Sjogren Syndrome. Finally, it was analysed whether or not the patients met the American European Consensus Group classification criteria and the preliminary European criteria for primary Sjogren Syndrome and secondary Sjogren Syndrome, and their sensitivity and specificity with respect to the clinical diagnosis were determined. Results Clinicians estimated that 35 cases (39.8%) had primary Sjogren Syndrome (kappa 0.718) and 17 cases (19.3%) had secondary Sjogren Syndrome (kappa 0.761). The specificity and sensitivity of American European Consensus Group criteria, with regard to the clinical diagnosis, for primary Sjogren Syndrome were 97.2% and 48.6%, respectively. For secondary Sjogren Syndrome, the specificity was 97.2% and the sensitivity 64.7%. The preliminary European criteria for primary Sjogren Syndrome demonstrated a lesser specificity (75%), but a higher sensitivity (65.7%). In secondary Sjogren Syndrome the specificity reached 97.2% with sensitivity at 70.6%. Conclusions These results underline the difficulty in applying the Sjogren Syndrome classification criteria from the American European Consensus Group and the preliminary European criteria, in the diagnosis of individual patients.