At a glance
- No single test confirms Sjögren's; gland function, autoimmunity and history are judged together.
- A positive anti-SSA antibody does not diagnose it alone, and a negative one does not rule it out.
- Classification criteria (ACR/EULAR 2016, Japan 1999) guide clinicians but do not replace their judgement.
01
No single test, so several tests together
There is no single test for Sjögren's disease. The NIAMS explains that diagnosis depends on how well the tear and salivary glands work and whether there is evidence of autoimmunity. A clinician starts with your history, especially how long dry eyes and dry mouth have lasted and whether they occur every day, then combines eye tests, saliva tests, blood tests and sometimes a biopsy or imaging. Other causes of dryness, such as medicines, are checked as well.
Diagnosis is usually led by a rheumatologist, a specialist in autoimmune disease, with an eye doctor or dentist carrying out some of the tests. This guide explains what each test measures and how the published criteria combine them, so you can follow the process; only the clinicians who examine you can say what your results mean.
02
The tests and what each one shows
Not everyone needs every test. Which ones are used depends on your symptoms, what the earlier results show and what is available locally.
| Test | What it measures | What to ask |
|---|---|---|
| Schirmer test | How much tear fluid wets a test strip in five minutes; 5 mm or less counts as reduced in the published criteria. | Were both eyes tested, and was anything used beforehand that could affect it? |
| Eye surface staining | A dye, such as fluorescein, shows damage to the surface of the eye caused by dryness. | Which dye and which scoring system were used? |
| Saliva flow | How much saliva the mouth produces over a set time, with or without stimulation (in Japan, often the gum test or Saxon test). | Was the result low, and could a medicine be reducing saliva? |
| Blood antibodies | Antibodies such as anti-SSA (Ro), and anti-SSB (La) in some criteria. They are common in Sjögren's but also occur in healthy people and other conditions. | Which antibodies were tested, and how do they fit with the other results? |
| Lip (minor salivary gland) biopsy | A small sample of the minor salivary glands in the lip, checked for clusters of immune cells (a focus score of 1 or more). | Is a biopsy needed in my case, and who will interpret it? |
| Salivary gland imaging | Ultrasound, or in Japan sialography or scintigraphy, to look for gland changes or reduced function. | What would imaging add to the results we already have? |
A positive antibody test does not establish the diagnosis on its own, and a negative one does not rule it out. That is why clinicians look for agreement between tests of gland function, signs of autoimmunity and the history, rather than relying on one result.
03
How published criteria combine the results
Two sets of criteria are widely cited. The 2016 ACR/EULAR criteria score five items in people with dryness symptoms or a suspected systemic feature; a total of 4 or more meets the criteria. The Japanese criteria, revised in 1999 and used for Japan's designated intractable disease system, require positive results in at least two of four groups.
| Item | ACR/EULAR 2016 (points) | Japan 1999 (one of four groups) |
|---|---|---|
| Lip or tear gland biopsy | Focus score of 1 or more: 3 points | Biopsy group: 1 or more focus per 4 mm² |
| Antibodies | Anti-SSA (Ro) positive: 3 points | Blood group: anti-SSA or anti-SSB positive |
| Eye tests | Ocular staining score of 5 or more: 1 point; Schirmer 5 mm/5 min or less: 1 point | Eye group: Schirmer 5 mm/5 min or less plus positive staining |
| Saliva tests | Unstimulated saliva flow 0.1 mL/min or less: 1 point | Mouth group: abnormal sialography, or low saliva with reduced function on scintigraphy |
| Threshold | Total of 4 or more | Positive in 2 or more groups |
The ACR/EULAR authors state that the main purpose of classification criteria is recruiting people into clinical trials and studies. In their validation, the criteria agreed with expert clinicians' judgement with 96% sensitivity and 95% specificity, so a small number of people are classified differently from the clinician's view. The criteria also exclude people with certain conditions that can mimic Sjögren's, such as previous head and neck radiation, active hepatitis C, sarcoidosis or IgG4-related disease.
04
Why a self-check cannot confirm it
Questions about daily dry eyes or dry mouth lasting several months are the entry point for the international criteria, so noticing them is useful. But dryness is common and has many causes, including medicines and other conditions. The NIAMS notes that lab or imaging tests are used to check for other causes, and that antibodies alone cannot make the diagnosis. No home test or online questionnaire can measure tear and saliva production accurately or show autoimmunity.
What you can do is prepare. Write down when dryness started, how often it happens, what helps, and any other symptoms such as swollen glands, joint pain, fatigue or rashes. Bring a full list of medicines, because some can make eye and mouth dryness worse, and any earlier eye, dental or blood test results. This gives the clinician a clear starting point for deciding which tests are needed.
05
Questions for the clinician
These questions can help you understand the plan and the results as they come in. Ask for copies of the reports so you can follow them over time.
- Which tests do you recommend first, and why?
- Could any of my medicines or other conditions explain the dryness?
- Which specialists will do the eye, dental or biopsy tests?
- How do my antibody results fit with the gland tests?
- Which criteria are you using, and does my situation meet them?
- If the results are unclear, what happens next and when should we review them?
Sources
- Sjögren's Disease: Diagnosis, Treatment, and Steps to TakeNational Institute of Arthritis and Musculoskeletal and Skin Diseases · 2024Source accessed:
- 2016 ACR-EULAR Classification Criteria for primary Sjögren's Syndrome (Arthritis & Rheumatology)American College of Rheumatology / EULAR (Shiboski and colleagues) · 2016Source accessed:
- 指定難病53 シェーグレン症候群 概要・診断基準等Ministry of Health, Labour and Welfare (Japan)Source accessed:
- シェーグレン症候群（指定難病53）Japan Intractable Diseases Information Center · 2025Source accessed:
- Sjögren's DiseaseNational Institute of Arthritis and Musculoskeletal and Skin Diseases · 2024Source accessed:
Revision history
- Initial English, Spanish and Japanese article prepared with automated assistance. The cited sources were checked for the complete article on 2026-10-31T03:07:48Z (UTC). Publication and preparation use the current date; no historical date was assigned. No independent clinical review is recorded.