Comprehensive panel
Screens a total of 7 traditional and novel biomarkers for a wide scope of analysis.
In-Office Procedures · Diagnostic Test
Sjö Designed for early detection of Sjögren's.
The Sjö Diagnostic Test by Immco analyzes a comprehensive set of biomarkers designed for advanced autoimmune dry eye and early detection of Sjögren's syndrome. It is a blood test that screens 7 traditional and novel biomarkers, performed at Immco's reference laboratory.
7Biomarkers screened
3Early-stage antibodies (SP-1, CA6, PSP)
2 weeksReport availability
Up to 4MPeople in the U.S. with Sjögren's
How it works
How the Sjö test works
A blood sample is collected in the office and sent to Immco's laboratory, where it is tested for traditional Sjögren's markers plus antibodies to salivary protein 1, carbonic anhydrase 6 and parotid secretory protein. These novel antibodies occurred earlier in the course of the disease than antibodies to Ro or La.
Proactive
Detecting autoimmune dry eye or Sjögren's syndrome early in the disease course can lead to better outcomes for the patient.
Precise
High specificity and significantly higher sensitivity than other screening methods.
Earlier markers
Antibodies to SP-1, CA6 and PSP were found in 45% of patients meeting the criteria for Sjögren's syndrome who lacked antibodies to Ro or La.
Shen et al. 2012What the panel measures
The full Sjögren's Syndrome Profile combines traditional autoantibodies with three novel early markers.
- 7 traditional and novel biomarkers
- Simple blood draw in office
- Free specimen collection kits
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SP-1, CA6 and PSP
IgG, IgA and IgM antibodies to salivary protein 1, carbonic anhydrase 6 and parotid secretory protein, measured by ELISA.
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SS-A (Ro) and SS-B (La)
Traditional Sjögren's autoantibodies measured by ELISA.
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ANA
Antinuclear antibody titer and pattern by indirect immunofluorescence on HEp-2 and mouse kidney.
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Rheumatoid factor
RF IgG, IgA and IgM measured by ELISA.
The test
Testing workflow
Order the panel with Immco's Sjögren's Syndrome test request form, collect blood in the office and ship it to the lab in the kit provided.
Sample
5 to 10 mL of blood in a red top or serum separator tube, with serum separated into the tube provided. Whatman blood spot cards are also accepted.
Time to result
Reports are available within two weeks of specimen receipt and can be retrieved 24/7 through Immco Online.
Lab-performed test
Performed at Immco's CLIA-certified reference laboratory (CLIA 33D0170905). Collection kits are supplied free of charge.
How Sjögren's is diagnosed
No single test confirms Sjögren's. Rheumatologists have primary responsibility for diagnosis and management, and an eye doctor may run tests when Sjögren's is suspected. The diagnosis draws on objective tests, symptom questions and a full medical history.
Blood tests
SS-A (Ro) and SS-B (La) are the marker antibodies for Sjögren's. About 70% of patients are positive for SS-A and 40% for SS-B. Both are also found in lupus.
Sjögren's FoundationEye tests
The Schirmer test measures tear production. Rose bengal and lissamine green dyes show dry spots on the ocular surface.
Sjögren's FoundationOral tests
Salivary flow measures how much saliva is produced over a set time. A minor salivary gland biopsy, usually from the lower lip, confirms lymphocytic infiltration.
Sjögren's FoundationWhy it is often missed
Sjögren's symptoms can mimic menopause, drug side effects, lupus, rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome and multiple sclerosis, and not every symptom appears at the same time. An eye care provider may be treating dry eye without realizing the patient has other symptoms. The Sjögren's Foundation reports that average time to diagnosis has fallen to 2.8 years, from over 6 years in 2012.
The 2016 classification criteria were written to enroll patients in clinical trials, not to diagnose patients in the clinic. Patients who do not meet them can still have Sjögren's.
History that can flag Sjögren's
- How long the patient has had dry eye
- Foreign body sensation in the eye
- How often artificial tears are used each day
- How long the patient has had dry mouth
- Swelling of the salivary glands
- Needing liquids to swallow food
Specifications
Technical specifications
| Test type | Send-out serum antibody panel |
|---|---|
| Biomarkers | SP-1, CA6, PSP, SS-A (Ro), SS-B (La), ANA, RF |
| Methodology | Indirect immunofluorescence and ELISA |
| Specimen | 5 to 10 mL blood in a red top or serum separator tube |
| Volume | 2 mL serum requested, 0.5 mL minimum |
| Stability | Ambient during shipment for 5 days; refrigerated (2 to 8°C) up to 5 days; frozen (-20°C or lower) up to 1 year |
| Report availability | Within two weeks of specimen receipt |
| Early marker reference range | <20 EU/mL negative; 20 to 25 EU/mL borderline; >25 EU/mL positive |
| Test codes | 076 Sjögren's Syndrome Profile; 093 Early Sjögren's Syndrome Profile |
| CPT codes (076) | 83520 (x9), 86038, 86431 (x3), 86235 (x2) |
| Laboratory CLIA number | 33D0170905 |
Common questions about Sjö
Why test dry eye patients for Sjögren's?
Sjögren's syndrome in its earliest stages commonly presents as routine dry eye, and on average there is a several-year delay in receiving an accurate diagnosis. Early diagnosis allows patients to be monitored for organ-specific manifestations, general symptoms, associated autoimmune diseases and malignancies.
How do I order testing?
Use the Sjögren's Syndrome test request form. Immco supplies specimen collection kits free of charge; call (716) 691-0091 or 800-537-TEST, ext. 310/321.
How long are specimens stable?
Stable at ambient temperature during shipment. If stored before shipment, stable refrigerated (2 to 8°C) for up to 5 days and frozen (-20°C) up to a year.
Can I use a blood spot card?
Yes. Fill the circles on the Whatman card completely, saturated through to the back of the card; underfilled cards may be rejected for insufficient volume.
Does insurance cover the test?
It depends on each plan, and some require pre-authorization. Immco works with state Medicare plans and many other providers but does not accept Medicaid, and does not balance bill patients.
How do I get results?
Through Immco Online, available 24/7 once results are posted.
Peer-reviewed clinical studies
Screen dry eye patients for Sjögren's earlier
A 7-biomarker blood panel that includes early-stage antibodies to SP-1, CA6 and PSP.
Sjö Diagnostic Test is a trademark of Immco Diagnostics. Review the full manufacturer instructions for use, including all warnings, precautions and contraindications, before use. Individual results vary.
