Ordering Recommendation

Aid in diagnosis of systemic sclerosis (SSc). Negative results do not rule out SSc. Preferred test is Comprehensive Systemic Sclerosis Panel (3000480).

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Serum separator tube.

Specimen Preparation

Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.25 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Plasma.  Contaminated, hemolyzed, or severely lipemic specimens.

Remarks
Stability

After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)

Methodology

Semi-Quantitative Multiplex Bead Assay

Performed

Sun-Sat

Reported

1-3 days

Reference Interval

Test Number
Components
Reference Interval
  Centromere Ab, IgG 0-40 AU/mL

Interpretive Data

When detected by this multiplex bead assay, the presence of centromere antibodies is mainly associated with CREST syndrome, a variant of systemic sclerosis (SSc). These antibodies target the centromere B, a dominant antigen of the centromeric complex associated with the centromere pattern observed in antinuclear antibody (ANA) testing by IFA. Centromere antibodies may also be seen in a varying percentage of patients with other autoimmune diseases, including diffuse cutaneous SSc, Raynaud syndrome, interstitial pulmonary fibrosis, autoimmune liver disease, systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA).

A negative result indicates no detectable IgG antibodies to centromere B. If the result is negative but clinical suspicion for SSc is strong, consider testing for ANA by IFA along with other antibodies associated with SSc, including Scl-70, U3-RNP, PM/Scl, or Th/To.


Component
Interpretation
Centromere Antibody, IgG 29 AU/mL or less            Negative
30-40 AU/mL                   Equivocal
41 AU/mL or greater      Positive

Compliance Category

FDA

Note

Hotline History

N/A

CPT Codes

83516

Components

Component Test Code* Component Chart Name LOINC
0050714 Centromere Ab, IgG 29966-9
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • ACA
  • Anti-centromere Antibodies
  • Anti-Centromere Antibody
  • Anticentromere Antibodies
  • Centromere Antibodies, IgG
  • CENTROMERE ANTIBODY
  • Centromere Autoantibodies
  • Centromere B
  • CREST
  • HEp-2
Centromere Antibody, IgG