A broad panel
Seven traditional and newer biomarkers give a wide view in a single test.
In-office procedures · Diagnostic test
Sjö A blood panel aimed at catching Sjögren's sooner.
Immco's Sjö Diagnostic Test looks at a broad biomarker panel built for autoimmune dry eye and early Sjögren's syndrome. The office draws blood, and Immco's reference laboratory screens it for 7 traditional and newer biomarkers.
7biomarkers in the panel
3early antibodies (SP-1, CA6, PSP)
2 weeksuntil the report is ready
Up to 4MAmericans living with Sjögren's
Why practices add it
What the test looks for
The practice draws blood and ships it to Immco's lab, which tests for the classic Sjögren's markers and for antibodies to salivary protein 1, carbonic anhydrase 6 and parotid secretory protein. Those newer antibodies appeared earlier in the disease than antibodies to Ro or La.
Early action
Catching Sjögren's or other autoimmune dry eye early can lead to better patient outcomes.
Accurate
High specificity, with sensitivity well above other screening approaches.
Markers that appear sooner
Among patients who met Sjögren's syndrome criteria but had no Ro or La antibodies, 45% had antibodies to SP-1, CA6 and PSP.
Shen et al. 2012Inside the panel
The complete Sjögren's Syndrome Profile pairs classic autoantibodies with three newer early markers.
- 7 traditional and newer biomarkers
- One blood draw in the office
- Collection kits at no charge
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SP-1, CA6 and PSP
ELISA for IgG, IgA and IgM against three gland proteins: salivary protein 1, carbonic anhydrase 6 and parotid secretory protein.
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SS-A (Ro) and SS-B (La)
The classic Sjögren's autoantibodies, run by ELISA.
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ANA
Reports both titer and staining pattern, read by indirect immunofluorescence on HEp-2 cells and mouse kidney.
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Rheumatoid factor
RF IgG, IgA and IgM, run by ELISA.
In the office
From order to report
Request the panel on Immco's Sjögren's Syndrome test request form, collect the sample chairside and mail it back in Immco's kit.
Specimen
5 to 10 mL of blood drawn into a red top or SST, then spun and poured off into the supplied tube. Whatman blood spot cards are accepted too.
Turnaround
Results post within two weeks of the lab receiving the specimen and can be pulled any time from Immco Online.
Run by the lab
Immco runs every sample in its own CLIA-certified reference lab (CLIA 33D0170905), and collection kits are free.
How a Sjögren's diagnosis is made
There is no single confirming test. Rheumatologists lead diagnosis and management, and an eye doctor may order testing when Sjögren's is suspected. The diagnosis combines objective testing, symptom questions and a complete medical history.
Blood tests
SS-A (Ro) and SS-B (La) are the hallmark Sjögren's antibodies. Roughly 70% of patients test positive for SS-A and 40% for SS-B, and both also appear in lupus.
Sjögren's FoundationEye tests
Schirmer testing measures tear output, and rose bengal and lissamine green stains reveal dry areas on the ocular surface.
Sjögren's FoundationOral tests
Salivary flow testing measures saliva produced over a fixed time, and a minor salivary gland biopsy, usually taken from the lower lip, confirms lymphocytic infiltration.
Sjögren's FoundationWhy it gets missed
Sjögren's can look like menopause, a medication side effect, lupus, rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome or multiple sclerosis, and symptoms rarely arrive together. The eye doctor may be managing dry eye with no idea the patient has other symptoms. According to the Sjögren's Foundation, the average time to diagnosis is now 2.8 years, compared with over 6 years back in 2012.
The 2016 classification criteria were designed to enroll clinical trial participants, not to diagnose patients in practice, so a patient who falls short of them may still have Sjögren's.
History clues that point to Sjögren's
- How long dry eye has been present
- A gritty or foreign body feeling
- How many times a day artificial tears are used
- How long dry mouth has been present
- Swollen salivary glands
- Needing a drink to get food down
Specs
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 for 5 days in transit; refrigerated (2 to 8°C) up to 5 days; frozen (-20°C or colder) up to 1 year |
| Report availability | Within two weeks of the lab receiving the specimen |
| 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 |
Questions doctors ask about Sjö
Why screen dry eye patients for Sjögren's?
Early Sjögren's syndrome usually looks like ordinary dry eye, and patients typically wait several years for the right diagnosis. Diagnosing it sooner means patients can be watched for organ involvement, systemic symptoms, related autoimmune disease and malignancy.
How do I order the test?
Fill out the Sjögren's Syndrome test request form. Immco sends collection kits free; call (716) 691-0091 or 800-537-TEST, ext. 310/321.
How stable are specimens?
They hold at room temperature during shipping. If they must be stored first, they last up to 5 days refrigerated (2 to 8°C) and up to a year frozen (-20°C).
Are blood spot cards accepted?
Yes. Fill each circle on the Whatman card completely so the blood soaks through to the back, because underfilled cards can be rejected for low volume.
Will insurance pay for it?
Coverage varies by plan, and some plans need pre-authorization. Immco bills state Medicare plans and a long list of other insurers; Medicaid is not accepted, and patients are never balance billed.
Where do results appear?
On Immco Online, which is open 24/7 once results post.
Published studies
Look for Sjögren's in your dry eye patients sooner.
Seven biomarkers in one blood panel, including the early SP-1, CA6 and PSP antibodies.
Sjö Diagnostic Test is a trademark of Immco Diagnostics. Read the complete manufacturer instructions for use, including every warning, precaution and contraindication, before use. Individual results vary.