Centromere Antibodies, IgG, Serum
Use
The test for Centromere Antibodies, IgG is crucial in evaluating patients who exhibit symptoms of systemic autoimmune rheumatic diseases, especially conditions such as systemic sclerosis, Sjogren’s syndrome, or overlap diseases. It assists in phenotypic stratification of patients with systemic sclerosis, distinguishing between limited cutaneous and diffuse cutaneous forms or determining the risk for specific clinical manifestations. The presence of anti-centromere antibodies is primarily associated with systemic sclerosis and can help stratify risks for cutaneous and organ involvement as well as survival outcomes. They are also occasionally observed in other autoimmune diseases like Sjogren’s syndrome, rheumatoid arthritis, and primary biliary cholangitis.
Special Instructions
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used as per the manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements. The test requires the serum to be collected in a serum gel or red top tube. The preferred specimen volume is 0.5 mL, but a minimum volume of 0.35 mL is acceptable. It is crucial to centrifuge and aliquot the serum into a plastic vial for submission. Be aware of specific rejection criteria such as gross hemolysis, lipemia, or heat-treated samples.
Limitations
The absence of anti-centromere antibodies does not rule out a diagnosis of systemic sclerosis or associated diseases. Detection of anti-centromere antibodies using solid-phase immunoassays may not always correlate with clinical disease presence. These antibodies have a broad specificity for the centromere–kinetochore macro-complex and demonstrate a discrete nuclear speckled pattern using indirect immunofluorescence assay. False negatives may occur if the appropriate centromere antigens are not expressed equivalently in the assay platforms used.
FDA ApprovedNew York Approved
Methodology
Immunoassay (Multiplex Flow Immunoassay)
Biomarkers
LOINC Codes
- 31290-0
- 31290-0
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
0.5 mL
Minimum Volume
0.35 mL
Container
Plastic vial
Collection Instructions
Centrifuge and aliquot serum into a plastic vial.
Causes for Rejection
Gross hemolysis, gross lipemia, or heat-treated samples.
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 21 days |
| Frozen | 21 days |