Scleroderma Comprehensive Profile
Use
The Scleroderma Comprehensive Profile is critical in assessing patients with suspected systemic sclerosis (SSc), a disease characterized by fibrosis, vascular alterations, and autoantibodies. The presence of specific autoantibodies can assist in diagnosis, predict clinical subsets, and guide management. For instance, Anti-RNA Polymerase III antibodies are important markers for diagnosing SSc and identifying patients at a higher risk for renal crisis and skin thickening. The prevalence of these antibodies varies across diffuse and limited SSc, reflecting diverse disease presentations.
Special Instructions
This test includes multiple assays for distinct antibodies involved in scleroderma, such as Anti-Scl-70, Anti-Centromere, and Anti-RNA Polymerase III. Reflex testing may occur depending on specific antibody concentrations or presence, which will incur additional charges. For reliable results, follow precise collection guidelines and ensure specimen volumes meet the minimal requirements, as insufficient samples cannot be retested.
Limitations
This assay is limited by its reliance on serological techniques, which may produce false-negative results if antibody concentrations are below detection thresholds. Additionally, while specific, these antibodies are not exclusive to scleroderma and may appear in other connective tissue diseases, potentially complicating differential diagnoses. Test interpretations should consider clinical correlation and may require supplementary tests to confirm disease presence or aid in prognostication.
New York Approved
Methodology
Immunoassay (ELISA)
Biomarkers
Result Turnaround Time
14-25 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
3 mL
Minimum Volume
1 mL
Container
Plastic vial
Collection Instructions
Draw blood in a plain red-top tube(s). Spin down and send 3 mL of serum refrigerated in a plastic vial.
Causes for Rejection
Gross hemolysis, gross lipemia, gross icterus, bacterial contamination, anything other than serum.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 7 days |
| Refrigerated | 14 days |
| Frozen | 60 days |