Test ID: CMA
Centromere Antibodies, IgG, Serum
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Evaluating patients with clinical signs and symptoms compatible with systemic sclerosis including skin involvement, Raynaud’s phenomenon, and arthralgias
As an aid in the diagnosis of calcinosis, Raynaud's phenomenon, esophageal dysfunction, sclerodactyly, and telangiectasis (CREST) syndrome
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
See Connective Tissue Disease Cascade (CTDC) in Special Instructions.
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Method Name A short description of the method used to perform the test
Multiplex Flow Immunoassay
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Anti-centromere Antibodies
Anticentromere Antibodies
Centromere Antibodies, IgG
CENTROMERE ANTIBODY
Centromere Autoantibodies
CREST
HEp-2
Scleroderma Antibodies (? FOR SPECIFIC TEST)
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Container/Tube:
Preferred: Red top
Acceptable: Serum gel
Specimen Volume: 0.5 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild OK; Gross reject |
| Lipemia | Mild OK; Gross reject |
| Icterus | Mild OK; Gross OK |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (preferred) | 21 days |
| Frozen | 21 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Centromere antibodies occur primarily in patients with the calcinosis, Raynaud's phenomenon, esophageal dysfunction, sclerodactyly, and telangiectasis (CREST) syndrome variant of systemic sclerosis (scleroderma). CREST syndrome is characterized by the following clinical features: calcinosis, Raynaud's phenomenon, esophageal hypomotility, sclerodactyly, and telangiectasia.(1) Centromere antibodies were originally detected by their distinctive pattern of fine-speckled nuclear staining on cell substrates used in the fluorescent antinuclear antibody test.(2) In subsequent studies, centromere antibodies were found to react with several centromere proteins of 18 kDa, 80 kDa, and 140 kDa named as CENP-A, CENP-B, and CENP-C, respectively.(3) Several putative epitopes associated with these autoantigens have been described. The CENP-B antigen is believed to be the primary autoantigen and is recognized by all sera that contain centromere antibodies.
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
In various reported clinical studies, centromere antibodies occur in 50% to 96% of patients with calcinosis, Raynaud's phenomenon, esophageal dysfunction, sclerodactyly, and telangiectasis (CREST) syndrome.
A positive test for centromere antibodies is strongly associated with CREST syndrome. The presence of detectable levels of centromere antibodies may antedate the appearance of diagnostic clinical features of CREST syndrome by several years.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Centromere antibodies have also been described in some patients with primary biliary cirrhosis, and may occur in patients with rheumatoid arthritis or lupus erythematosus.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. White B: Systemic sclerosis. In Clinical Immunology Principles and Practice. 2nd edition. Edited by R Rich, T Fleisher, W Shearer, et al. St. Louis, Mosby-Year Book, 2001, Chapter 64, pp 64.1-64.10
2. Tan EM, Rodnan GP, Garcia I, et al: Diversity of antinuclear antibodies in progressive systemic sclerosis. Anti-centromere antibody and its relationship to CREST syndrome. Arthritis Rheum 1980;23:617-625
3. Kallenberg CG: Anti-centromere antibodies (ACA). Clin Rheum 1990;9:136-139
Method Description Describes how the test is performed and provides a method-specific reference
Recombinant 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, Hercules, CA)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Saturday; 4 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
83520
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| CMA | Centromere Ab, IgG, S | 31290-0 |
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