Breast Carcinoma-Associated Antigen (CA 27.29), Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
The FDA has approved CA 27.29 for serial testing in women with prior stage II or III breast cancer who are clinically free of disease.
Predicting early recurrence of disease in women with treated carcinoma of the breast
As an indication that additional tests or procedures should be performed to confirm recurrence of breast cancer
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Breast Carcinoma Assoc Ag(CA 27.29)
Biomira Truquant BR
Breast Cancer Tumor Markers
Cancer Antigen 27.29 (CA 27.29)
Breast Cancer Tumor Markers
Cancer Antigen 27.29 (CA 27.29)
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: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL
Forms: If not ordering electronically, submit a General Request Form (Supply T239) with the specimen.
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
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||Frozen (preferred)||90 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Carcinoma of the breast is the most prevalent form of cancer in women. These tumors often produce mucinous antigens that are large-molecular-weight glycoproteins with O-linked oligosaccharide chains.
Monoclonal antibodies directed against these antigens have been developed, and several immunoassays are available to quantitate the levels of tumor-associated mucinous antigens in serum. The antibodies recognize epitopes of a breast cancer-associated antigen encoded by the human mucin 1 (MUC-1) gene, which is known by several names including MAM6, milk mucin antigen, CA 27.29, and cancer antigen 15-3 (CA 15-3).
While CA 27.29 is expressed at the apical surface of normal epithelial cells, it is present throughout malignant epithelial cells of the breast, lung, ovary, pancreas, and other sites. The cancer-associated form of the antigen is less extensively glycosylated than the normal form and more specific for tumor cells.
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.
> or =18 years: < or =38.0 U/mL (use not defined)
> or =18 years: < or =38.0 U/mL
Reference values have not been established for patients that are <18 years of age.
Serum markers are not specific for malignancy, and values may vary by method.
Increased levels of CA 27.29 (>38 U/mL) may indicate recurrent disease in a woman with treated breast carcinoma.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This test provides results on female patients only at this time.
The use of CA 27.29 has not been demonstrated to provide clinical benefit to these patients, which has led some Mayo clinical investigators to conclude there is insufficient justification for routine clinical use of this new marker.
Measurement of CA 27.29 is not useful to screen women for carcinoma of the breast.
Some patients who have been exposed to mouse antigens, either in the environment or as part of treatment or imaging procedure, may have circulating antimouse antibodies present. These antibodies may interfere with the assay reagents to produce unreliable CA 27.29 results.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Bon GG, Von Mensdorff-Pouilly S, Kenemans P, et al: Clinical and technical evaluation of ACS BR serum assay of MUC1 gene-derived glycoprotein in breast cancer, and comparison with CA 15-3 assays. Clin Chem 1997;43:585-593
2. Chan DW, Beveridge RA, Muss H, et al: Use of Truquant BR radioimmunoassay for early detection of breast cancer recurrence in patients with stage II and stage III disease. J Clin Oncol 1997;15:2322-2328
Method Description Describes how the test is performed and provides a method-specific reference
This is a chemiluminometric immunoassay, CA 27.29 is measured using an automated, competitive, chemiluminescent immunoassay on the Advia: Centaur instrument. The signal (Lite) reagent is a monoclonal antibody specific for CA 27.29, which is labeled with acridinium ester. Purified CA 27.29 antigen attached to paramagnetic particles (solid phase) competes with the antigen in the specimen for binding to the monoclonal antibody. An inverse relationship exists between the amount of CA 27.29 in the patient specimen and the amount of relative light units detected by the system.(Package insert: Bayer Advia Centaur CA 27.29. Bayer Diagnostics, East Walpole, MA)
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; 6 a.m.-6 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.
Same day/1 day
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.
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|
|C2729||Breast Carcinoma Assoc Ag(CA 27.29)||17842-6|