Test Code LAB3419 Centromere Antibodies, IgG, Serum
Reporting Name
Centromere Ab, IgG, SUseful For
Evaluating patients with features of systemic autoimmune rheumatic disease, particularly systemic sclerosis, Sjogren’s syndrome, or overlap disease
Aiding in the phenotypic stratification of patients with systemic sclerosis (limited cutaneous vs diffuse cutaneous or risk for specific clinical manifestations)
Testing Algorithm
For more information see Connective Tissue Disease Cascade.
Performing Laboratory

Specimen Type
SerumSpecimen Required
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL
Collection Instructions: Centrifuge and aliquot serum into a plastic vial.
Specimen Minimum Volume
0.35 mL
Specimen Stability Information
Specimen Type | Temperature | Time |
---|---|---|
Serum | Refrigerated (preferred) | 21 days |
Frozen | 21 days |
Special Instructions
Reference Values
<1.0 U (negative)
≥1.0 U (positive)
Reference values apply to all ages.
Day(s) Performed
Monday through Saturday
Test Classification
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
83516
LOINC Code Information
Test ID | Test Order Name | Order LOINC Value |
---|---|---|
CMA | Centromere Ab, IgG, S | 31290-0 |
Result ID | Test Result Name | Result LOINC Value |
---|---|---|
CMA | Centromere Ab, IgG, S | 31290-0 |
Cautions
Absence of anti-centromere antibodies by any of the methods, especially solid-phase immunoassays, does not rule out a diagnosis of systemic sclerosis or associated diseases.
Low levels of anti-centromere antibodies detected using solid-phase immunoassays may have low predictive value for disease. Confirmation using HEp-2 substrate by immunofluorescence assay may be useful if clinical suspicion for systemic sclerosis is high.
Using HEp-2 substrate, the centromere pattern maybe positive and the CENP-B solid-phase negative due to differences in the expression of antigens between the two methods.
Report Available
Same day/1 to 3 daysReject Due To
Gross hemolysis | Reject |
Gross lipemia | Reject |
Gross icterus | OK |
Heat-Treated | Reject |
NY State Approved
YesMethod Name
Multiplex Flow Immunoassay