Table 1.

The 2016 ACR/EULAR classification criteria for pSS.²⁰

Consensus criteria items for the classification of pSS:
Abnormal unstimulated salivary flow rate* (⩽0.1 ml/min)	(1 point)
Abnormal Schirmer’s test (<5 mm in 5 min)	(1 point)
Abnormal findings with lissamine green or fluorescein staining
⩾5 in Ocular Staining Score or ⩾4 in Van Bijsterveld Score	(1 point)
Presence of anti-Ro/SSA antibodies	(3 points)
Histological evidence of focal lymphocytic sialadenitis,$ with a focus score ⩾1 focus/4 mm2 (1 focus = 50 lymphocytes/4 mm2)	(3 points)
Diagnosis is considered established if score ⩾4 points, after application of inclusion and exclusion criteria
Inclusion criteria:
Dryness of eyes or mouth for at least 3 months, not explained otherwise (e.g. medications, infection)
Exclusion criteria:
Status post head/neck radiation
HIV/AIDS
Sarcoidosis
Active infection with hepatitis C virus (PCR replication rate)
Amyloidosis, graft versus host disease, IgG4-related disease
The lack of any other potentially associated disease is the key requirement for classification as pSS

^*The patient is asked to sit still, not to speak or to chew for 5–15 min; the saliva produced during this time is transferred to a test tube and weighed.

^$Biopsy: removal of 3–5 labial minor salivary glands from the lower lip under local anaesthesia; fixation of biopsy material in formalin and HE staining.

ACR/EULAR, American College of Rheumatology/European League Against Rheumatism; AIDS, acquired immunodeficiency syndrome; HE, hematoxylin and eosin stain; HIV, human immunodeficiency virus; IgG, immunoglobulin G; PCR, polymerase chain reaction; pSS, primary Sjögren’s syndrome.