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Test Code LAB3419 Centromere Antibodies, IgG, Serum

Reporting Name

Centromere Ab, IgG, S

Useful 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

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum


Specimen 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 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus OK
Heat-Treated Reject

NY State Approved

Yes

Method Name

Multiplex Flow Immunoassay

Secondary ID

9278