Abstract: Objective：To validate the American College of Rheumatology Classification (ACR) Criteria (2012) for the diagnosis of primary Sjögren’s syndrome in Chinese patients.Methods:All patients involved in this study came from the Department of Oral Medicine Peking University Stomatology Hospital. They were devided into two groups of pSS and non-pSS according to the diagnoses made by two experts. Both groups of the patients had completed medical records kept in the hospital. Results: A total of 239 pSS patients (160 with labial salivary gland biopsy, and 79 without biopsy) and 52 age-matched non-pSS patients ［(55.17±14.295)，and (55.90±13.38) years old, P>0.05］ (9 with biopsy, and 43 without biopsy) were involved in this study. The sensitivity and specificity of ACR criteria in diagnosing pSS were 90.37 % and 88.46 % respectively. The positive and negative likelihood ratios were 7.83 and 0.109, respectively. The sensitivities of ACR criteria in diagnosing pSS patients with and without labial biopsy were 88.75% and 93.67 %, respectively, with specificities of 88.89% and 88.37%, respectively. The most sensitive item adopted in ACR criteria was the ocular staining score with a sensitivity of 85.77%, and the most specific item was the labial salivary gland biopsy, with a specificity of 88.89%. Conclusion:The sensitivity and specificity of ACR criteria in diagnosing Chinese pSS patients were relatively high, and may serve as the diagnosis criteria in research and clinical practice. However, the ACR criteria need to be validated and further revised in the future .

Key words: Sjögren’s syndrome, Diagnosis, Sensitivity and specificity