diagnostic criteria

sjogren's syndrome diagnostic criteria 




I. Ocular symptoms: a positive response to at least one of the following questions:



1. Have you had daily, persistent, troublesome dry eyes for more than 3/12?


2. Do you have a recurrent sensation of sand or gravel in the eyes?


3. Do you use tear substitutes more than 3 times a day?


II. Oral symptoms: a positive response to at least one of the following questions:





1. Have you had a daily feeling of dry mouth for more than 3 months?


2. Have you had recurrent swollen salivary glands as an adult?


3. Do you frequently drink liquids to aid in swallowing dry food?


III. Ocular signs: that is, objective evidence for at least one of the following two tests:




1. Schirmer's I test, performed without anaesthesia (<5 mm in 5 minutes)


2. Rose Bengal score or other ocular dye score


IV. Histopathology:



In minor salivary glands (obtained through normal-appearing mucosa) focal lymphocytic sialoadenitis, evaluated by an expert histopathologist, with a focus score >1, defined as a number of lymphocytic foci (which are adjacent to normal-appearing mucous acini and contain more than 50 lymphocytes) per 4 mm2 of glandular tissue.


V. Salivary gland involvement: objective evidence of salivary gland involvement defined by a positive result for at least one of the following diagnostic tests:



1. Unstimulated whole salivary flow (<1.5 ml in 15 minutes)


2. Parotid sialography showing the presence of diffuse sialectasias (punctate, cavitary or destructive pattern), without evidence of obstruction in the major ducts.


3. Salivary scintigraphy showing delayed uptake, reduced concentration and/or delayed excretion of tracer.


VI. Autoantibodies: presence in the serum of the following autoantibodies:



1 . Antibodies to Ro(SSA) or La(SSB) antigens, or both                                             |


For primary SS

Primary SS may be defined as follows:

a.  The presence of any 4 of the 6 items is indicative of primary SS, as long as
either item IV (Histopathology) or VI (Serology) is positive

b.  The presence of any 3 of the 4 objective criteria items (items III, IV, V, VI)

For secondary SS

In patients with a potentially associated disease (for instance, another well defined connective tissue disease), the presence of item I or item II plus any 2 from among items III, IV, and V may be considered as indicative of secondary SS.

Exclusion criteria:


Past head & neck radiotherapy


Hepatitis C infection




Pre-existing iymphoma




Graft versus host disease


Use of anticholinergic drugs


X = excluded