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Test Code FSCPR Scleroderma Comprehensive Profile


Specimen Required


Collection Container/Tube: 10 mL Red

Submission Container/Tube: Plastic vial

Specimen Volume: 3 mL

Acceptable: SST

Collection Instructions: Draw blood in a plain red-top tube(s), serum gel tube is acceptable. Spin down and send 3 mL of serum refrigerated in a plastic vial.


Method Name

RIPA Gel Radiography

Immunofluorescence Antibody

Enzyme-linked immunosorbent assay (ELISA)

Reporting Name

Scleroderma Comp Profile

Specimen Type

Serum

Specimen Minimum Volume

1 mL (volume does not allow for repeat testing)

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 14 days
  Frozen  60 days
  Ambient  7 days

Reject Due To

Gross hemolysis: Reject
Thawing: Warm OK; Cold OK
Gross lipemia: Reject
Gross icterus Reject
Other: Anything other than serum; bacterial contamination

Clinical Information

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 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 prevalence of IgG RNAP III antibodies is 20-35% in diffuse SSC and 9% in limited SSc.

Reference Values

Anti-Nuclear Ab by IFA, Anti-U3 RNP(Fibrillarin), Anti-Th/To Ab:

Reference Range: Negative

 

Anti-Centromere Ab:

Reference Range: <1:40

 

Anti-SCL-70 Ab:

Reference Range: <20

 

Anti-RNA Polymerase III, Anti-U1RNP Ab, and Anti-PM/Scl-100 Ab:

Reference Range: <20

Negative: <20 units

Weak Positive: 20-39 units

Moderate Positive: 40-80 units

Strong Positive: >80 units

Day(s) Performed

Monday through Friday

Report Available

14 to 25 days

Performing Laboratory

Esoterix Endocrinology

Test Classification

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

CPT Code Information

86038

83516

86235 x 5

86256

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
FANTP ANA Titer and Pattern No No
FCA70 Repeat Anti Scl-70 No No