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Scleroderma Comprehensive Profile (RDL)

CPT: 83516; 86038; 86235(x5); 86256

Synonyms

  • SCL Panel

Test Includes

Anti-Nuclear Ab (ANA) by IFA; Anti-Scl 70 Ab; Anti-RNA Polymerase III Ab; Anti-Centromere Ab; Anti-Th/To Ab; Anti-U1 RNP Ab; Anti-U3 RNP (Fibrillarin) Ab; and Anti-PM/Scl-100 Ab


Expected Turnaround Time

14 - 21 days


Specimen Requirements


Specimen

Serum


Volume

3 mL


Minimum Volume

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


Container

Red-top tube or gel-barrier tube


Collection

Separate serum from cells within one hour of collection. Transfer to a plastic transport tube before shipping. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.


Storage Instructions

Refrigerate or freeze.


Stability Requirements

Temperature

Period

Room temperature

7 days

Refrigerated

14 days

Frozen

60 days

Freeze/thaw cycles

Stable x1


Causes for Rejection

Grossly hemolyzed; bacterial contamination; lipemic specimen; icteric specimen; non-serum specimen types


Test Details


Use

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

• Anti-Th/To Abs are present in 2-6% of patients with limited SSC and are rarely found in diffuse SSc. They have specificity and are associated with isolated pulmonary arterial HTN, pulmonary fibrosis, and renal crisis.

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

• Anti-PM/SCL Abs are found in 25% of Scleroderma/myositis overlap, 10% of idiopathic inflammatory myopathy and 2% of Scleroderma cutaneous changes and ILD.

• Anti-RNA Polymerase III Abs 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 prevelance of IgG RNAP III antibodies is 20-35% in diffuse SSc and 9% in limited SSc.


Limitations

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


Methodology

See individual test components.


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