Centromere Antibodies, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Evaluation of patients with clinical signs and symptoms compatible with systemic sclerosis
Immunofluorescence Assay (IFA)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Centromere Antibodies, S
Anti Centromere Ab, S
Centromere Antibody, Serum
Centromere Antibody, Serum
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.
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.
Mild OK; Gross reject
Mild OK; Gross OK
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum||Refrigerated (preferred)||14 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Antinuclear antibodies are seen in a number of autoimmune disorders such as systemic lupus erythematosus, mixed connective tissue disease, rheumatoid arthritis, Sjogren syndrome, and progressive systemic sclerosis.
One autoantibody that produces a distinct staining pattern is the anticentromere antibody (ACA). ACA occurs in patients with the calcinosis, Raynaud phenomenon, esophageal hypomotility, sclerodactyly, and telangiectasia (CREST) syndrome variant of progressive systemic sclerosis.
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.
Negative (titer of <1:40)
Positives will be titered.
A positive test for anticentromere antibody (ACA) is strongly associated with calcinosis, Raynaud phenomenon, esophageal hypomotility, sclerodactyly, and telangiectasia (CREST) syndrome. In various reported clinical studies, ACA occur in 50% to 96% of patients with CREST syndrome.
The presence of detectable levels of ACA may antedate the appearance of diagnostic clinical features of CREST syndrome, in some cases by several years.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Anticentromere antibody have also been described in some patients with primary biliary cirrhosis, and rarely, in patients with rheumatoid arthritis or lupus erythematosus.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
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
In this assay, autoantibodies in a test sample bind to antigens in the substrate (human epithelial cells, Hep-2). Washing removes excess serum from the substrate. Fluorescein conjugated (FITC) antiserum added to the substrate attaches to the bound autoantibody. After a second washing step to remove excess conjugate, the substrate is coverslipped and viewed for fluorescent patterns with a fluorescent microscope. Observation of a specific pattern on the substrate indicates the presence of autoantibodies in the test sample.(Package Insert: Zeus Scientific ANA/Hep-2 Cell Culture IFA Test System, Product Series 2400/24000. Issued April 27, 2004)
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 Friday, Sunday; 3rd shift
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.
1 day/2 days if positive
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.
This test has been cleared or approved by the U.S. 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
86256-Titer (if appropriate)
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|