Test Catalog

Test Id : CMA

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Centromere Antibodies, IgG, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

For more information see Connective Tissue Disease Cascade.

Method Name
A short description of the method used to perform the test

Multiplex Flow Immunoassay

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Centromere Ab, IgG, S

Aliases
Lists additional common names for a test, as an aid in searching

Anticentromere Antibodies

Centromere Antibodies, IgG

Centromere Autoantibodies

HEp-2

Centromere Antibody

Anti-Centromere Antibodies

ACA

Scleroderma Antibodies

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

For more information see Connective Tissue Disease Cascade.

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.35 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

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

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 21 days
Frozen 21 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

For more information see Connective Tissue Disease Cascade.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

The presence of anti-centromere antibody (ACA) is associated with antinuclear antibody and demonstrates a characteristic discrete nuclear speckled staining pattern of both interphase nuclei and metaphase chromatin on HEp-2 substrate by indirect immunofluorescence assay (IFA).(1,2) ACA has a broad specificity for the centromere–kinetochore macro-complex.(2) Several putative epitopes associated with this autoantigenic complex have been described with CENP-A (18 kDa), CENP-B (80 kDa), CENP-C (140 kDa, and CBX as the main targets.(1-4) The CENP-B antigen is believed to be the primary autoantigen in systemic autoimmune diseases and is recognized by most, if not all, sera that contain centromere antibodies.(1-4) Together with anti-Scl 70 and anti-RNA polymerase III autoantibodies, ACA is recommended for the diagnostic classification systemic sclerosis (SSc) by the American College of rheumatology/European League Against Rheumatism collaborative initiative.(5)

 

Historically, ACA has been associated with SSc but also occur in varying frequencies in autoimmune diseases such as Sjögren's syndrome (SjS), primary biliary cholangitis (PBC), PBC overlap disease, or overlap connective tissue disease (CTD), and rheumatoid arthritis.(1-7) ACA is the most detected SSc-specific autoantibody and it is typically associated with the limited cutaneous SSc (lcSSc), previously referred to as CREST syndrome which is comprised of calcinosis, Raynaud phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia.(1,3,6,8) In addition, ACA has a higher frequency in Caucasian than in African American or Asian cohorts.(1,7,8) The lcSSc is characterized by skin fibrosis of the fingers (sclerodactyly) and, in some cases, of the face and neck or the skin distal to the elbows and/or knees, sparring the upper arms, upper legs, or trunk.(1,7,8) Based on the autoantibody and cutaneous phenotypic characterization, ACA-positive patients with lcSSc generally have the highest 20-year survival, lowest incidence of clinically significant pulmonary fibrosis, scleroderma renal crisis, and lowest incidence of cardiac SSc.(2,5,7,8)

 

In addition to SSc, ACAs occur in patients with SjS, rheumatoid arthritis, PBC overlap, or overlap CTD.(1-7) Recent studies aimed at determining the fine specificities ACA in different CTD demonstrated comparative frequencies to CENP-B, the major ACA target.(2,4) In both studies, ACA recognize centromere “complex” rather than individual protein, and this feature is common among patients with Sjogren’s syndrome, SSc and PBC.

 

In routine clinical evaluation, ACA as well as ACA-specific for CENP-B and CENP-A, can be detected using a variety of methods.(1,9,10) The ACA detected using HEp-2 substrate by IFA, broadly defines a heterogeneous population of centromeric proteins (centromere-kinetochore macro-complex) while most solid-phase immunoassays for clinical evaluation are designed with mainly CENP-B antigen.(10)

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

<1.0 U (negative)

> or =1.0 U (positive)

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

Anti-centromere antibodies are mainly associated with systemic sclerosis and may be useful in the risk stratification for cutaneous and organ involvement as well as survival outcomes. They may also be observed in other autoimmune diseases such as Sjogren’s syndrome, rheumatoid arthritis, primary biliary cholangitis and overlap diseases.

 

Detectable levels of anti-centromere antibodies may predate overt clinical features of systemic sclerosis or related diseases.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Stochmal A, Czuwara J, Trojanowska M, et al. Antinuclear antibodies in systemic sclerosis: an update. Clin Rev Allergy Immunol 2020;58(1):40-51

2. Kajio N, Takeshita M, Suzuki K, et al. Anti-centromere antibodies target centromere-kinetochore macrocomplex: a comprehensive autoantigen profiling. Ann Rheum Dis. 2021;80(5):651-659

3. Earnshaw W, Bordwell B, Marino C, Rothfield N. Three human chromosomal autoantigens are recognized by sera from patients with anti-centromere antibodies. J Clin Invest. 1986;77(2):426-430

4. Takeshita M, Suzuki K, Kaneda Y, et al. Antigen-driven selection of antibodies against SSA, SSB and the centromere 'complex', including a novel antigen, MIS12 complex, in human salivary glands. Ann Rheum Dis. 2020;79(1):150-158

5. van den Hoogen F, Khanna D, Fransen J, et al. 2013 classification criteria for systemic sclerosis: an American College of rheumatology/European League against rheumatism collaborative initiative. Ann Rheum Dis 2013;72(11):1747-1755

6. Kuramoto N, Ohmura K, Ikari K, et al. Anti-centromere antibody exhibits specific distribution levels among anti-nuclear antibodies and may characterize a distinct subset in rheumatoid arthritis. Sci Rep. 2017;7(1):6911

7. Cavazzana I, Vojinovic T, Airo P, et al. Systemic sclerosis-specific antibodies: novel and classical biomarkers. Clin Rev Allergy Immunol. 2023;64(3):412-430

8. Nihtyanova SI, Sari A, Harvey JC, et al. Using autoantibodies and cutaneous subset to develop outcome-based disease classification in systemic sclerosis. Arthritis Rheumatol. 2020;72(3):465-476

9. Fritzler MJ, Rattner JB, Luft LM, et al. Historical perspectives on the discovery and elucidation of autoantibodies to centromere proteins (CENP) and the emerging importance of antibodies to CENP-F. Autoimmun Rev. 2011;10(4):194-200

10. Bossuyt X, De Langhe E, Borghi MO, Meroni PL. Understanding and interpreting antinuclear antibody tests in systemic rheumatic diseases. Nat Rev Rheumatol. 2020;16(12):715-726

Method Description
Describes how the test is performed and provides a method-specific reference

Recombinant centromere protein (CENP-B) antigen is coupled covalently to polystyrene microspheres, which are impregnated with fluorescent dyes to create a unique fluorescent signature. Centromere antibodies, if present in diluted serum, bind to the CENP-B antigen on the microspheres. The microspheres are washed to remove extraneous serum proteins. Phycoerythrin (PE)-conjugated antihuman IgG antibody is then added to detect IgG anti-CENP-B bound to the microspheres. The microspheres are washed to remove unbound conjugate, and bound conjugate is detected by laser photometry. A primary laser reveals the fluorescent signature of each microsphere to distinguish it from microspheres that are labeled with other antigens, and a secondary laser reveals the level of PE fluorescence associated with each microsphere. Results are calculated by comparing the median fluorescence response for CENP-B microspheres to a 4-point calibration curve.(Package insert: BioPlex 2200 ANA Screen. Bio-Rad Laboratories; 02/2019)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

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  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

83516

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
CMA Centromere Ab, IgG, S 31290-0
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
CMA Centromere Ab, IgG, S 31290-0

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports