Early Sjogren's Syndrome Profile

Test Code

93748

Alias/See Also

LAB00508

CPT Codes
83520 (x9)

Includes

Carbonic Anhydrase VI (CA VI) IgG Antibodies, Carbonic Anhydrase VI (CA VI) IgA Antibodies, Carbonic Anhydrase VI (CA VI) IgM Antibodies
Parotid Specific Protein (PSP) IgG Antibodies, Parotid Specific Protein (PSP) IgA Antibodies, Parotid Specific Protein (PSP) IgM Antibodies
Salivary Protein 1 (SP-1) IgG Antibodies, Salivary Protein 1 (SP-1) IgA Antibodies, Salivary Protein 1 (SP-1) IgM Antibodies

Preferred Specimen

2 mL serum

Minimum Volume

0.5 mL

Instructions

Specimen need not be refrigerated or frozen. Collect 2-3 mL of blood in a red-top or Serum separator tube (SST). If possible, separate serum from clot and place into white tube provided with Immco Diagnostics' collection kits.
If separation facilities are not available, the blood can be sent in the tube used for collection.

Transport Container

Transport tube

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 5 days
Refrigerated: 5 days
Frozen: 1 year

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Gross hemolysis • Grossly lipemic • Grossly icteric • Specimens other than serum

Methodology
Enzyme Linked Immunosorbent Assay (ELISA)

FDA Status
This test has been developed and performance parameters have been validated by IMMCO Diagnostics, Inc. This test has not been approved by the U.S. Food and Drug Administration (FDA); however, US FDA approval is not required for clinical use. It is not intended that clinical diagnosis and patient management decisions be made using these results alone.
This test has been validated using serum samples. The manufacturer has not determined the efficacy of this test when performed on CSF, plasma, joint, or pleural fluid specimens. The performance characteristics of this test were determined by IMMCO Diagnostics, Inc.

Setup Schedule

Once every 2 weeks

Report Available

2 weeks from specimen receipt

Reference Range

See Laboratory Report

Clinical Significance

Sjogren's syndrome (SS) is a systemic autoimmune disease in which loss of salivary gland and lachrymal gland function is associated with hypergammaglobulinemia, autoantibody production, mild kidney and lung disease and eventually lymphoma. SS involves dry eyes and dry mouth without systemic features that may be either primary or secondary to another autoimmune disease, such as SLE. Patients with SS and picked up at a late stage in their disease, after the salivary glands and lachrymal glands are already destroyed, because they are asymptomatic until that time. At this point, only symptomatic treatment can be offered for abnormal lachrymal and salivary gland function. The diagnosis for SS is currently at a crossroad with the American College of Rheumatology providing which requires characteristic autoantibodies (SS-A/SS-B) or minor salivary gland biopsy. Since lip biopsies are not frequently performed in clinical practice, there is increased emphasis placed on autoantibodies in diagnosis. The current Ro and La antibodies can delay the diagnosis by over 6 years.Recently novel antibodies identified to salivary gland protein 1 (SP-1), carbonic anhydrase 6 (CA6) and parotid secretory protein (PSP) using western blot methodology. Further studies have shown that the isotype differentiation of the markers adds to the sensitivity of diagnosis of SS. These autoantibodies occurred earlier in the course of the disease than antibodies to Ro or La. In addition antibodies to SP-1, CA-6 and PSP were found in patients meeting the criteria for SS who lacked antibodies to Ro or La. Furthermore, in patients with idiopathic xerostomia and xerophthalmia for less than 2 years, 76% had antibodies to SP-1 and/or CA6 while only 31% had antibodies to Ro or La.
Antibodies to different isotypes (IgG, IgM & IgA of SP-1, CA6 and PSP are useful markers for identifying patients with SS at early stages of the disease or those that lack antibodies to either Ro or La.

Performing Laboratory

Immco Diagnostics, Inc

10 Earhart Drive, Suite 100

Williamsville, NY 14221

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.