Objective To evaluate the sensitivity and specificity of international classification criteria （2002） for primary Sjgren’s syndrome （pSS） and the role of lower lip biopsy in diagnosis of pSS in Chinese patients. Methods Patients who were diagnosed by the experts/rheumatologists as pSS during 1990-2002 from the Depart- ment of Rheumatology

Peking Union Medical College Hospital were retrospectively collected as experimental group. Patients who were diagnosed as non-pSS connective tissue diseases or non-connective tissue diseases served as control group. Those with a history of head-neck radiation

hepatitis C virus infection

AIDS

lymphoma

sarcoidosis

graft versus host disease （GVHD）

and anti-acetylcholine drug use were exempted. Both groups were required to complete question- naires about symptoms such as dry eyes and dry mouth

and complete the objective tests of keratoconjunctivitis and xero- stomia including Schirmer test

corneal staining

unstimulated salivary flow

sialography

lower lip biopsy

and antinuclear antibodies （including anti-SSA/SSB antibodies） test. Results A total of 330 pSS patients were included in experimental group and 185 non-pSS patients in control group. The mean age of both groups matched （47.8 ± 10.9 years vs. 46.2 ± 13.6 years

P > 0.05）. The sensitivities of the criteria in pSS patients with lower lip biopsy and in pSS patients without lower lip biopsy were 89.2% and 87.2%

respectively; the overall sensitivity was 88.5%. The specificity was 97.3%. A total of 11.3% pSS patients with negative anti-SSA/SSB anti- bodies were diagnosed as pSS by lower lip biopsy. Conclusion The international classification criteria （2002） for pSS is feasible in Chinese patients. It has high sensitivity and specificity

and may serve as diagnosis criteria in routine clinical practice.