Scleroderma Comprehensive Plus Profile (RDL)

Serum

4 mL

3 mL (Note: This volume does not allow for repeat testing.)

Red-top tube or gel-barrier tube

The new Scleroderma Comprehensive Plus Profile is the most comprehensive Scleroderma panel available on the market, and when combined with typical clinical features, can assist in the diagnosis and management of early or established disease. Identifying autoantibodies earlier in the disease can aid in diagnosis, prognosis and predicting the risk for end-stage organ complications, allowing for more aggressive intervention. In Scleroderma patients, anti-PM/Scl-75 and anti-PM/Scl-100 antibodies can be found in diffuse or limited cutaneous disease. The presence of both antibodies is highly associated with inflammatory Myositis.

This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the Food and Drug Administration.

See individual test components.

Scleroderma Profile Interpretation

• Anti-Nuclear Abs: Positive in more than 95% of patients with Scleroderma.

• Anti-Centromere Abs are found in more than 95% of patients with Scleroderma.

• Anti-Centromere Abs are found in 46% of patients with limited Systemic Sclerosis and 11% in diffuse Systemic Sclerosis, as well as 12% of patients with primary biliary cirrhosis, and are rarely present in normal individuals. The antibodies recognize primarily Centromere B, a major centromere protein, and are associated with CREST Syndrome.

• Anti-Scl 70 are highly specific for scleroderma. They are present in about 20% of diffuse SSc, and 10% of limited SSc. The antibodies are associated with digital ulcers, Raynaulds, pulmonary fibrosis, renal crises, and heart disease. EIA testing can yield false positive results, therefore, all EIA positive tests are confirmed with immunodiffusion.

• Anti-U1 RNP abs can be found in 2-14% of limited SSc and 5% of diffuse SSc, They are associated with isolated pulmonary arterial hypertension, arthritis, and esophageal dysfunction.

• Anti-TH/TO abs can be found in 2-6% of patients with limited SSc and are rarely found in diffuse SSc. They are associated with isolated pulmonary arterial hypertension, arthritis, and esophageal dysfunction.

• Anti-Fibrillarin (U3 RNP) are highly specific for diffuse SSc with a sensitivity of 4-10%. They are associated with isolated arterial hypertension, myositis, and cardiac manifestations of SSc.

• Anti-RNA Polymerase III are useful in the diagnosis of SSc and for the identification of patients at risk for developing renal crisis, progressive skin thickening and cancer. The prevalence of IgG RNAP III antibodies is 20-30% in diffuse SSc and 9% in limited SSc.