American-European Consensus Criteria for Sjögren’s Syndrome

In order to make a diagnosis of Sjögren’s syndrome, the following criteria must be met:

I. Ocular Symptoms (at least one)

  • Symptoms of dry eyes for at least 3 months
  • A foreign body sensation in the eyes
  • Use of artificial tears 3 or more times per day

II. Oral Symptoms (at least one)

  • Symptoms of dry mouth for at least 3 months
  • Recurrent or persistently swollen salivary glands
  • Need for liquids to swallow dry foods

III. Ocular Signs (at least one)

  • Abnormal Schirmer’s test, (without anesthesia; ≤5 mm/5 minutes)
  • Positive vital dye staining of the eye surface

IV. Histopathology

  • Lip biopsy showing focal lymphocytic sialoadenitis (focus score ≥1 per 4 mm2)

V. Oral Signs (at least one)

  • Unstimulated whole salivary flow (≤1.5 mL in 15 minutes)
  • Abnormal parotid sialography
  • Abnormal salivary scintigraphy

VI. Autoantibodies (at least one)

  • Anti-SSA (Ro) or Anti-SSB (La), or both

For a primary Sjögren’s syndrome diagnosis:

  • Any 4 of the 6 criteria, must include either item IV (Histopathology) or VI (Autoantibodies)
  • Any 3 of the 4 objective criteria (III, IV, V, VI) 

For a secondary Sjögren’s syndrome diagnosis:

In patients with another well-defined major connective tissue disease, the presence of one symptom (I or II) plus 2 of the 3 objective criteria (III, IV and V) is indicative of secondary SS.

Exclusion Criteria

  • Past head and neck radiation treatment
  • Hepatitis C infection
  • Acquired immunodeficiency syndrome (AIDS)
  • Pre-existing lymphoma
  • Sarcoidosis
  • Graft versus host disease
  • Current use of anticholinergic drugs


Vitali C, et al. Classification criteria for Sjogren’s syndrome: a revised version of the European criteria proposed by the American-European Consensus Group. Ann Rheum Dis 2002; 61:554-558.