Scleroderma Profile

Test Code

18310

CPT Codes
83516, 86038, 86331<br><strong>This test is not available for New York patient testing.</strong><br>Restricted Client Code

Preferred Specimen

2 mL serum collected in two red stopper tubes

Minimum Volume

0.5 mL

Other Acceptable Specimens

Serum separator tube (SST)

Instructions

Two red stopper (serum) tubes are preferred. After blood is collected, red stopper tubes must be kept at 37 C until blood has clotted in the tubes. Centrifuge and remove the serum, refrigerate until transported to our lab. Specimen can be sent at ambient temperature.

Specimen tubes should be labeled with the patient?s name, identification number if applicable, date of birth and the date of collection.

A requisition must be included, completed with the patient's name, identification number, date of birth, sex, requesting physician and address, billing address (or copy of insurance card), and date of collection.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 7 days
Refrigerated: 14 days
Frozen: 30 days

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

Contaminated sample • Quantity not sufficient • Improperly labeled specimen • Patient name, DOB, or other identifying information on the sample label does not match the information on the test order • Leaking or broken container

Methodology
Immunodiffusion • Immunofluorescence • Immunoprecipitation

FDA Status
This test was developed and its performance characteristics determined by the OMRF Clinical Immunology Laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary.

Setup Schedule

Set up: Weekly; Report available: 6-8 weeks

Reference Range

Negative

Clinical Significance

Scleroderma (systemic sclerosis) is a connective tissue disorder that involve the hardening and tightening of the skin. Scleroderma also may cause problems in the blood vessels, internal organs and digestive tract.

Anti-centromere antibodies (ACA) and anti-Scl-70 antibodies are useful in distinguishing patients with systemic sclerosis (SSc) from healthy controls, from patients with other connective tissue disease, and from unaffected family members. Whereas ACA often predict a limited skin involvement and the absence of pulmonary involvement, the presence of anti-Scl-70 antibodies increases the risk for diffuse skin involvement and scleroderma lung disease. Anti-fibrillarin autoantibodies (which share significant serologic overlap with anti-U3-ribonucleoprotein antibodies) and anti-RNA-polymerase autoantibodies occur less frequently and are also predictive of diffuse skin involvement and systemic disease. Anti-Th/To and PM-Scl are associated with limited skin disease, but anti-Th/To may be a marker for the development of pulmonary hypertension. Anti-U1-ribonucleoprotein, in high titer, is seen in patients with SSc/systemic lupus erythematosus/polymyositis overlap syndromes. Anti-Ku is detected in patients with SSc, idiopathic inflammatory myopathy (IIM), Sjogren's syndrome (SS), and systemic lupus erythematosus (SLE). Anti-Ku is a marker for overlap syndrome.

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.