State of the Art Diagnostics for Sjögren’s Syndrome

Sjögren’s Syndrome (SS) is one of the common autoimmune disorders affecting over 4 million Americans of which 90% are women. It is often seen in association with other autoimmune diseases, especially systemic lupus erythematosus and rheumatoid arthritis. The hallmark symptoms are severe dry mouth and/or eyes, due to destruction of the salivary and lachrymal glands. Almost 4% of patients with SS will develop lymphoma, predominantly B cell non-Hodgkin lymphomas.

Traditional Disease Diagnosis

• Multiple tests need to be carried out including serology, imaging and biopsy
• No early markers available
• Delay in diagnosis of up to 6 years
• Most salivary and lachrymal glands are completely destroyed by the time diagnosis is established

Novel Markers for Early Diagnosis

• Proprietary and new markers SP-1, CA6 and PSP
• Increases the sensitivity to over 80%
• Enables diagnosis early before the traditional markers (Ro/La) appear
• Early diagnosis leads to better disease management when glands are still functional

Sjogren’s lab tests brochure

Immco Sjögren’s Panel

Combines novel and traditional markers for early diagnosis with higher sensitivity and specificity.

076 Sjogren Syndrome Profile (includes all tests below)
001 ANA Titer and Pattern (HEp2/Mouse kidney)
011 Rheumatoid Factor levels (IgG, IgA, IgM)
045 SS-A (Ro)
046 SS-B (La)
094 Salivary Protein-I (SP-1)
095 Carbonic Anhydrase – 6 (CA6)
095 Parotid Specific Protein (PSP)

093 Early Sjogren Syndrome Profile (includes all tests below)
094 Salivary Protein-I (SP-1)
095 Carbonic Anhydrase – 6 (CA6)
096 Parotid Specific Protein (PSP)

097 Comprehensive Sjogren Profile (includes all tests below)
001 ANA Titer and Pattern (HEp2/Mouse kidney)
011 Rheumatoid Factor levels (IgG, IgA, IgM)
045 SS-A (Ro)
046 SS-B (La)
094 Salivary Protein-I (SP-1)
095 Carbonic Anhydrase – 6 (CA6)
096 Parotid Specific Protein (PSP)
511 H&E studies of minor salivary gland biopsies with Focus Scores

Sample Submission

Collect 5-10 ml of blood in red top or serum separator tube. If possible, separate serum from clot and place serum in orange or clear tube provided. Do not puncture top of tube. If separation facilities are not available, the blood can be sent in the collection tube. Minor salivary glands need to be collected from normal appearing mucosal site. At least 6-7 minor salivary gland lobules need to be collected and placed in 10% Formalin and transported.

Ship to Immco Diagnostics

Pack Specimen Collection Kit following these simple steps:
1. Place tube(s) into specimen collection bag.
2. Place test requisition(completely filled out) and a copy of the patient’s medical insurance information and any other pertinent paperwork into the outside pocket of specimen bag.
3. Fold and roll specimen bag and contents into white mailer box and place in Orange FedEx Clinical Pak.
4. Place Pre-paid FedEx return airbill on the outside of Clinical Pak and call FedEx for a pick up at 1-800-463-3339.

Overnight Courier Service: Please follow instructions contained in the Specimen Collection Kit and send to: Immco Diagnostics, Inc. 640 Ellicott Street, Buffalo, NY 14203