In patients with primary Sjögren's syndrome sensitivity of Japanese criteria was 82.0% and specificity was 82.7%: sensitivity of European criteria was 73.3%, and specificity was 88.9%. In patients with secondary Sjögren's syndrome sensitivity of Japanese criteria was 74.5% and specificity was 85.7%: sensitivity of European criteria was 70.2%, and specificity was 89.3%. False-negative patients with decreased sensitivity of both criteria mostly showed a positive labial salivary gland biopsy without ovart dry mouth and dry eye symptoms. False-positive patients with decreasing specificity of both criteria were those who had only keratoconcunctivitis sicca without a positive labial salivary gland biopsy.