Table 1.

The 2016 American College of Rheumatology/European League Against Rheumatism Sjögren’s syndrome classification criteria

Item	Weight/score
The classification of primary Sjögren’s syndrome (SS) applies to any individual who meets the inclusion criteriaa, does not have any of the conditions listed as exclusion criteriab and has a score of ≥4 when the weights of the five criteria items below are summed
Labial salivary gland with focal lymphocytic sialadenitis and focus score of ≥1 foci/4 mmc	3
Anti-SSA/Ro-positive	3
Ocular staining score ≥5 (or van Bijsterveld score ≥4) in at least one eyed, e	1
Schirmer’s test ≤5 mm/5 min in at least one eyed	1
Unstimulated whole saliva flow rate ≤0.1 mL/mind, f	1

^aThese inclusion criteria are applicable to any patient with at least one symptom of ocular or oral dryness, defined as a positive response to at least one of the following questions [1]: Have you had daily, persistent, troublesome dry eyes for more than 3 months [2]? Do you have a recurrent sensation of sand or gravel in the eyes [3]? Do you use tear substitutes more than three times a day [4]? Have you had a daily feeling of dry mouth for more than 3 months [5]? Do you frequently drink liquids to aid in swallowing dry food?—or in whom there is suspicion of SS from the European League Against Rheumatism Sjögren’s syndrome Disease Activity Index questionnaire (at least one domain with a positive item)

^bExclusion criteria include prior diagnosis of any of the following conditions, which would exclude the diagnosis of Sjögren’s syndrome and participation in Sjögren’s syndrome studies or therapeutic trials because of overlapping clinical features or interference with criteria tests [1]: history of head and neck radiation treatment [2], active hepatitis C infection (with confirmation by PCR) [3], acquired immunodeficiency syndrome, [4] sarcoidosis, [5] amyloidosis [6], graft-versus-host disease [7], immunoglobulin G4-related disease

^cThe histopathologic examination should be performed by a pathologist with expertise in the diagnosis of focal lymphocytic sialadenitis and focus score count, using the protocol described by Daniel et al. [134]

^dPatients who are normally taking anticholinergic drugs should be evaluated for objective signs of salivary hypofunction and ocular dryness after a sufficient interval without these medications in order for these components to be a valid measure of oral and ocular dryness

^eOcular staining Score described by Whitcher et al. [135] and by the van Bijsterveld score described by van Bijsterveld [136]

^fUnstimulated whole saliva flow rate measurement described by Navazesh and Kumar [137]